ENABLE-ALL: Clinical Trial for Non-responders Who Previously Participated in Eltrombopag Studies TPL 103922 or TPL 108390

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00996216
• Collaborator: (none)
• Enrollment: 27
• Locations: 28
• Arm: 1
• Duration (Months): 41
• Patients Per Site: 1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to test the safety and tolerability of eltrombopag when used to increase and maintain platelet count. Platelet count to be maintained at a level sufficient to facilitate initiation of antiviral therapy, to minimize antiviral therapy dose reductions, and to avoid permanent discontinuation of antiviral therapy.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C	Drug: Eltrombopag; Drug: Antiviral therapy	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Multi-centre Rollover Study to Assess the Safety and Efficacy of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2a or Peginterferon Alfa-2b Plus Ribavirin)
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Feb 1, 2013
• Actual Study Completion Date: Feb 1, 2013

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Open-label eltrombopag Open-label eltrombopag with dose titrations to support adequate platelet counts.

Drug: Eltrombopag; Eltrombopag starting at 25 mg dose and titrated in Part 1 of study to 50, 75, 100 mg. Platelet count must reach sufficient level to allow initiation of antiviral therapy. Eltrombopag dose may be adjusted during antiviral treatment phase of study to maintain platelet count to continue antiviral therapy without adjustment to antiviral dose.; Other Names: Promacta ; Drug: Antiviral therapy; Combination of either peginterferon alfa-2a or alfa-2b with ribavirin at investigator's discretion.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part 1 [From the start of investigational product up to the start of antiviral therapy (up to 9 weeks; median of 21 days)]

   An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.

2. Number of Participants With Any AE and Any SAE in Part 2 [From the date of initiation of antiviral therapy (Antiviral Baseline Visit [between Study Day 14 and Study Day 65]) to the completion of the follow-up period (up to Week 96/WD)]

   An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.

3. Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 [From Screening up to the start of antiviral therapy (up to 9 weeks; median of 21 days)]

   Blood samples were collected for the measurement of clinical chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.

4. Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 [From Day 0 of Part 2 (Antiviral Baseline Visit [between Study Day 14 and Study Day 65) to the completion of the follow-up period (up to Week 96/WD)]

   Blood samples were collected for the measurement of clinical chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.

5. Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 [From Screening up to the start of antiviral therapy (up to 9 weeks; median of 21 days)]

   Blood samples were collected for the measurement of hematology parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.

6. Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 [From Day 0 of Part 2 (Antiviral Baseline Visit [between Study Day 14 and Study Day 65) to the completion of the follow-up period (up to Week 96/WD)]

   Blood samples were collected for the measurement of hematology chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.

7. Number of Participants With a Decrease in Visual Acuity During Parts 1 and 2 [From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)]

   Visual acuity (VA) is defined as acuteness or clearness of vision.

8. Number of Participants With the Indicated Change in logMAR Scale Values During Parts 1 and 2 [From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)]

   LogMAR (logarithm of the minimum angle of resolution) charts are used to measure an individual's visual acuity. LogMAR, expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30), converts the geometric sequence of a traditional chart to a linear scale. As there are 5 letters per line, the total score for a line on the LogMAR chart represents a change of 0.1 log units.

9. Number of Participants With a logMAR Change >=0.15 During Parts 1 and 2 [From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)]

   LogMAR (logarithm of the minimum angle of resolution) charts are used to measure an individual's visual acuity. LogMAR, expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30), converts the geometric sequence of a traditional chart to a linear scale. As there are 5 letters per line, the total score for a line on the LogMAR chart represents a change of 0.1 log units.

Secondary Outcome Measures

1. Platelet Counts at the Indicated Time Points [From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)]

   Blood samples were collected for the measurement of platelet count. For each participant, the duration of Part 1 treatment varies between 2 and 9 weeks.

2. Number of Particpants Who Initiated Antiviral Therapy [From the start of the investigational product up to 9 weeks (median of 21 days)]

   The number of participants who completed the Pre-antiviral Phase (Part 1) and proceeded to the Antiviral Phase (Part 2) are summarized.

3. Number of Participants Achieving Antiviral Treatment Milestones of Sustained Virological Response (SVR), Rapid Virological Response (RVR), Early Virological Response (EVR), and End of Treatment Response (ETR) [From the start of investigational product in Part 2 up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)]

   SVR is defined as non-detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of the planned treatment period (i.e., Week 48 or 72 for genotype 2/3 or Week 72 for non-genotype 2/3). RVR is defined as undetectable HCV RNA after 4 weeks of antiviral treatment. EVR is defined as clinically significant reduction in HCV RNA (>=2 log10 drop or undetectable) after 12 weeks of antiviral treatment. ETR is defined as undetectable HCV RNA at the end of antiviral treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Prior participation in protocol TPL103922 or TPL108390 and completed the Week 24 Follow Up Visit in TPL103922 or TPL108390

• Male or female ≥18 years old

• Evidence of chronic HCV infection

• While participating in TPL103922 or TPL108390, discontinued from study drug due to thrombocytopenia

• Appropriate candidate for antiviral therapy with pegylated interferon plus ribavirin

• Platelet count <75,000

• Fertile males and females must use two forms of effective contraception during treatment and for 24 weeks after treatment

• Ability to understand and comply with the protocol requirements and instructions

• Ability to provide written informed consent

Exclusion Criteria:

• Decompensated liver disease

• Known hypersensitivity, intolerance, or allergy to interferon, ribavirin, eltrombopag, or their ingredients

• History of clinically significant bleeding from oesophageal or gastric varices

• History of arterial or venous thrombosis and two or more of the following risk factors: hereditary thrombophilic disorders; hormone replacement therapy; systemic contraception (containing estrogen); smoking; diabetes; hypercholesterolemia; medication for hypertension or cancer

• Pre-existing cardiac disease (congestive heart failure Grade III/IV) or arrhythmias known to involve the risk of thromboembolic events (e.g. atrial fibrillation)

• Evidence of hepatocellular carcinoma

• HIV or Hepatitis B infection

• Therapy with anti-neoplastic or immunomodulatory treatment within six months prior to eltrombopag therapy

• Malignancy diagnosed or treated within the past five years. Except for localized basal or squamous cell carcinoma treated by local excision or malignancies that were adequately treated and, in the opinion of the oncologist, have an excellent chance of cancer-free survival.

• Pregnant or nursing women

• Men with a female partner who is pregnant

• History of alcohol/drug abuse or dependence within six months of the study start unless participating in a controlled rehabilitation programme.

• Treatment with an investigational drug or interferon within 30 days or 5 half-lives (whichever is longer) of the screening visit

• History or platelet clumping that prevents reliable measurement of platelet counts

• Evidence of portal vein thrombosis within three months of baseline visit

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	San Diego	California	United States	92123
2	GSK Investigational Site	New Haven	Connecticut	United States	06520
3	GSK Investigational Site	Honolulu	Hawaii	United States	96817
4	GSK Investigational Site	Manhasset	New York	United States	11030
5	GSK Investigational Site	Nashville	Tennessee	United States	37212
6	GSK Investigational Site	Seattle	Washington	United States	98111
7	GSK Investigational Site	Camperdown	New South Wales	Australia	2050
8	GSK Investigational Site	Randwick	New South Wales	Australia	2031
9	GSK Investigational Site	Herston	Queensland	Australia	4029
10	GSK Investigational Site	Toronto	Ontario	Canada	M5G 2N2
11	GSK Investigational Site	Montreal	Quebec	Canada	H2X 3J4
12	GSK Investigational Site	Marseille Cedex 08		France	13285
13	GSK Investigational Site	Nice cedex 3		France	06202
14	GSK Investigational Site	Pessac Cedex		France	33604
15	GSK Investigational Site	Freiburg	Baden-Wuerttemberg	Germany	79106
16	GSK Investigational Site	Ulm	Baden-Wuerttemberg	Germany	89081
17	GSK Investigational Site	Muenchen	Bayern	Germany	81675
18	GSK Investigational Site	Duesseldorf	Nordrhein-Westfalen	Germany	40225
19	GSK Investigational Site	Berlin		Germany	10969
20	GSK Investigational Site	Athens		Greece	10676
21	GSK Investigational Site	Bologna	Emilia-Romagna	Italy	40138
22	GSK Investigational Site	Genova	Liguria	Italy	16132
23	GSK Investigational Site	Milano	Lombardia	Italy	20157
24	GSK Investigational Site	Lahore		Pakistan	54600
25	GSK Investigational Site	La Coruña		Spain	15006
26	GSK Investigational Site	Madrid		Spain	28029
27	GSK Investigational Site	Pontevedra		Spain	36071
28	GSK Investigational Site	Valencia		Spain	46010

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00996216
• Other Study ID Numbers: 108392
• First Posted: Oct 16, 2009
• Last Update Posted: Dec 6, 2013
• Last Verified: Aug 1, 2013

• Keywords provided by GlaxoSmithKline: Peginterferon; Platelets; Ribavirin; Hepatitis C-related thrombocytopenia; Thrombocytopenia; Hepatitis C; Thrombopoietin
• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Antiviral Agents

Study Results

Participant Flow

Recruitment Details	10^9 cells (Giga) per liter=Gi/L; participants=par.; polyethylene glycol=Peg; interferon=INF.
Pre-assignment Detail	In Part (P) 1, the treatment goal was to increase the platelet count to >=90 Gi/L. In P 2, par. continued on the selected P 1 dose of eltrombopag (dose effectively raising platelets to >=90 or >=100 Gi/L). Eltrombopag was given in combination with antiviral therapy (Peg INF alfa-2a or Peg INF alfa-2b and ribavirin) for the duration of treatment.

Arm/Group Title	Eltrombopag
Arm/Group Description	In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
Period Title: Part 1 (Pre-Antiviral Treatment Phase)
STARTED	27
COMPLETED	26
NOT COMPLETED	1
Period Title: Part 1 (Pre-Antiviral Treatment Phase)
STARTED	25
COMPLETED	21
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Eltrombopag
Arm/Group Description	In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
Overall Participants	27
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	51.3 (7.70)
Sex: Female, Male (Count of Participants)
Female	7 25.9%
Male	20 74.1%
Race/Ethnicity, Customized (participants) [Number]
Central/South Asian Heritage	2 7.4%
White	25 92.6%

Outcome Measures

1. Secondary Outcome

Title	Platelet Counts at the Indicated Time Points
Description	Blood samples were collected for the measurement of platelet count. For each participant, the duration of Part 1 treatment varies between 2 and 9 weeks.
Time Frame	From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)

Outcome Measure Data

Analysis Population Description

Pre-antiviral Safety Population

Arm/Group Title	Eltrombopag
Arm/Group Description	In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
Measure Participants	27
Screening, n=27	53.1 (12.90)
Part 1/Day 1, n=27	55.9 (18.69)
Part 1/Week 1, n=25	73.3 (29.27)
Part 1/Week 2, n=16	83.2 (27.90)
Part 1/Week 3, n=8	73.4 (26.53)
Part 1/Week 4, n=7	75.6 (19.95)
Part 1/Week 5, n=5	72.2 (18.29)
Part 1/Week 6, n=5	81.6 (14.45)
Part 1/Week 7, n=5	76.2 (19.88)
Part 1/Week 8, n=3	91.7 (22.81)
Part 2/Antiviral Baseline, n=25	132.9 (33.72)
Part 2/Week 1, n=25	106.7 (37.80)
Part 2/Week 2, n=25	93.2 (42.98)
Part 2/Week 4, n=23	80.5 (30.64)
Part 2/Week 8, n=21	80.3 (24.40)
Part 2/Week 12, n=20	83.1 (31.72)
Part 2/Week 16, n=16	85.8 (27.61)
Part 2/Week 20, n=14	75.3 (22.54)
Part 2/Week 24, n=11	78.6 (30.63)
Part 2/Week 28, n=9	90.3 (50.09)
Part 2/Week 32, n=7	86.1 (72.12)
Part 2/Week 36, n=6	76.8 (53.77)
Part 2/Week 40, n=5	55.8 (27.65)
Part 2/Week 44, n=5	54.4 (29.18)
Part 2/Week 48, n=2	68.0 (29.70)
Part 2/Week 52, n=1	49.0 (NA)
Part 2/Week 56, n=1	47.0 (NA)
Part 2/Week 60, n=1	43.0 (NA)
Part 2/Week 64, n=1	43.0 (NA)
Part 2/Week 68, n=1	44.0 (NA)
Post-treatment/4 Week Follow-up, n=23	77.8 (33.48)
Post-treatment/24 Week Follow-up, n=22	52.5 (17.91)
Investigational product discontinuation, n=26	91.3 (38.78)
Maximum value post-Baseline, n=26	145.5 (43.68)

2. Secondary Outcome

Title	Number of Particpants Who Initiated Antiviral Therapy
Description	The number of participants who completed the Pre-antiviral Phase (Part 1) and proceeded to the Antiviral Phase (Part 2) are summarized.
Time Frame	From the start of the investigational product up to 9 weeks (median of 21 days)

Outcome Measure Data

Analysis Population Description

Pre-antiviral Safety Population

Arm/Group Title	Eltrombopag
Arm/Group Description	In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
Measure Participants	27
Yes	25 92.6%
No	2 7.4%

3. Primary Outcome

Title	Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part 1
Description	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.
Time Frame	From the start of investigational product up to the start of antiviral therapy (up to 9 weeks; median of 21 days)

Outcome Measure Data

Analysis Population Description

Pre-antiviral Safety Population: all participants who received study drug in the Pre-antiviral Treatment Phase (Part 1) of the study

Arm/Group Title	Eltrombopag
Arm/Group Description	In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
Measure Participants	27
Any SAE	0 0%
Any AE	9 33.3%

4. Primary Outcome

Title	Number of Participants With Any AE and Any SAE in Part 2
Description	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.
Time Frame	From the date of initiation of antiviral therapy (Antiviral Baseline Visit [between Study Day 14 and Study Day 65]) to the completion of the follow-up period (up to Week 96/WD)

Outcome Measure Data

Analysis Population Description

Antiviral Safety Population: all participants who entered the Antiviral Treatment Phase (Part 2) of the study and who received at least one dose of antiviral therapy

Arm/Group Title	Eltrombopag
Arm/Group Description	In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
Measure Participants	25
Any SAE	5 18.5%
Any AE	25 92.6%

5. Primary Outcome

Title	Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1
Description	Blood samples were collected for the measurement of clinical chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.
Time Frame	From Screening up to the start of antiviral therapy (up to 9 weeks; median of 21 days)

Outcome Measure Data

Analysis Population Description

Pre-antiviral Safety Population. Only participants with data available at the specified time point were analyzed.

Arm/Group Title	Eltrombopag
Arm/Group Description	In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
Measure Participants	26
Alanine amino transferase, Any Increase	2 7.4%
Alanine amino transferase, Increase to Grade 1	1 3.7%
Alanine amino transferase, Increase to Grade 2	0 0%
Alanine amino transferase, Increase to Grade 3	1 3.7%
Alanine amino transferase, Increase to Grade 4	0 0%
Albumin, Any Increase	1 3.7%
Albumin, Increase to Grade 1	1 3.7%
Albumin, Increase to Grade 2	0 0%
Albumin, Increase to Grade 3	0 0%
Albumin, Increase to Grade 4	0 0%
Alkaline phosphatase, Any Increase	1 3.7%
Alkaline phosphatase, Increase to Grade 1	1 3.7%
Alkaline phosphatase, Increase to Grade 2	0 0%
Alkaline phosphatase, Increase to Grade 3	0 0%
Alkaline phosphatase, Increase to Grade 4	0 0%
Aspartate amino transferase, Any Increase	2 7.4%
Aspartate amino transferase, Increase to Grade 1	2 7.4%
Aspartate amino transferase, Increase to Grade 2	0 0%
Aspartate amino transferase, Increase to Grade 3	0 0%
Aspartate amino transferase, Increase to Grade 4	0 0%
Creatinine, Any Increase	0 0%
Creatinine, Increase to Grade 1	0 0%
Creatinine, Increase to Grade 2	0 0%
Creatinine, Increase to Grade 3	0 0%
Creatinine, Increase to Grade 4	0 0%
Total bilirubin, Any Increase	10 37%
Total bilirubin, Increase to Grade 1	6 22.2%
Total bilirubin, Increase to Grade 2	4 14.8%
Total bilirubin, Increase to Grade 3	0 0%
Total bilirubin, Increase to Grade 4	0 0%
Uric acid, Any Increase	3 11.1%
Uric acid, Increase to Grade 1	3 11.1%
Uric acid, Increase to Grade 2	0 0%
Uric acid, Increase to Grade 3	0 0%
Uric acid, Increase to Grade 4	0 0%

6. Primary Outcome

Title	Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2
Description	Blood samples were collected for the measurement of clinical chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.
Time Frame	From Day 0 of Part 2 (Antiviral Baseline Visit [between Study Day 14 and Study Day 65) to the completion of the follow-up period (up to Week 96/WD)

Outcome Measure Data

Analysis Population Description

Antiviral Safety Population

Arm/Group Title	Eltrombopag
Arm/Group Description	In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
Measure Participants	25
Alanine amino transferase, Any Increase	4 14.8%
Alanine amino transferase, Increase to Grade 1	3 11.1%
Alanine amino transferase, Increase to Grade 2	0 0%
Alanine amino transferase, Increase to Grade 3	1 3.7%
Alanine amino transferase, Increase to Grade 4	0 0%
Albumin, Any Increase	9 33.3%
Albumin, Increase to Grade 1	4 14.8%
Albumin, Increase to Grade 2	5 18.5%
Albumin, Increase to Grade 3	0 0%
Albumin, Increase to Grade 4	0 0%
Alkaline phosphatase, Any Increase	7 25.9%
Alkaline phosphatase, Increase to Grade 1	7 25.9%
Alkaline phosphatase, Increase to Grade 2	0 0%
Alkaline phosphatase, Increase to Grade 3	0 0%
Alkaline phosphatase, Increase to Grade 4	0 0%
Aspartate amino transferase, Any Increase	9 33.3%
Aspartate amino transferase, Increase to Grade 1	1 3.7%
Aspartate amino transferase, Increase to Grade 2	8 29.6%
Aspartate amino transferase, Increase to Grade 3	0 0%
Aspartate amino transferase, Increase to Grade 4	0 0%
Creatinine, Any Increase	1 3.7%
Creatinine, Increase to Grade 1	0 0%
Creatinine, Increase to Grade 2	0 0%
Creatinine, Increase to Grade 3	1 3.7%
Creatinine, Increase to Grade 4	0 0%
Total bilirubin, Any Increase	16 59.3%
Total bilirubin, Increase to Grade 1	1 3.7%
Total bilirubin, Increase to Grade 2	5 18.5%
Total bilirubin, Increase to Grade 3	10 37%
Total bilirubin, Increase to Grade 4	0 0%
Uric acid, Any Increase	5 18.5%
Uric acid, Increase to Grade 1	4 14.8%
Uric acid, Increase to Grade 2	1 3.7%
Uric acid, Increase to Grade 3	0 0%
Uric acid, Increase to Grade 4	0 0%

7. Primary Outcome

Title	Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1
Description	Blood samples were collected for the measurement of hematology parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.
Time Frame	From Screening up to the start of antiviral therapy (up to 9 weeks; median of 21 days)

Outcome Measure Data

Analysis Population Description

Pre-antiviral Safety Population. Only participants with data available at the specified time point were analyzed.

Arm/Group Title	Eltrombopag
Arm/Group Description	In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
Measure Participants	26
Hemoglobin, Any Increase	2 7.4%
Hemoglobin, Increase to Grade 1	2 7.4%
Hemoglobin, Increase to Grade 2	0 0%
Hemoglobin, Increase to Grade 3	0 0%
Hemoglobin, Increase to Grade 4	0 0%
Lymphocytes, Any Increase	3 11.1%
Lymphocytes, Increase to Grade 1	1 3.7%
Lymphocytes, Increase to Grade 2	1 3.7%
Lymphocytes, Increase to Grade 3	1 3.7%
Lymphocytes, Increase to Grade 4	0 0%
Total neutrophils, Any Increase	3 11.1%
Total neutrophils, Increase to Grade 1	3 11.1%
Total neutrophils, Increase to Grade 2	0 0%
Total neutrophils, Increase to Grade 3	0 0%
Total neutrophils, Increase to Grade 4	0 0%
White Blood cell count, Any Increase	2 7.4%
White Blood cell count, Increase to Grade 1	0 0%
White Blood cell count, Increase to Grade 2	2 7.4%
White Blood cell count, Increase to Grade 3	0 0%
White Blood cell count, Increase to Grade 4	0 0%

8. Primary Outcome

Title	Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2
Description	Blood samples were collected for the measurement of hematology chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.
Time Frame	From Day 0 of Part 2 (Antiviral Baseline Visit [between Study Day 14 and Study Day 65) to the completion of the follow-up period (up to Week 96/WD)

Outcome Measure Data

Analysis Population Description

Antiviral Safety Population

Arm/Group Title	Eltrombopag
Arm/Group Description	In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
Measure Participants	25
Hemoglobin, Any Increase	12 44.4%
Hemoglobin, Increase to Grade 1	1 3.7%
Hemoglobin, Increase to Grade 2	5 18.5%
Hemoglobin, Increase to Grade 3	5 18.5%
Hemoglobin, Increase to Grade 4	1 3.7%
Lymphocytes, Any Increase	15 55.6%
Lymphocytes, Increase to Grade 1	1 3.7%
Lymphocytes, Increase to Grade 2	3 11.1%
Lymphocytes, Increase to Grade 3	3 11.1%
Lymphocytes, Increase to Grade 4	8 29.6%
Total neutrophils, Any Increase	23 85.2%
Total neutrophils, Increase to Grade 1	4 14.8%
Total neutrophils, Increase to Grade 2	10 37%
Total neutrophils, Increase to Grade 3	8 29.6%
Total neutrophils, Increase to Grade 4	1 3.7%
White Blood Cell count, Any Increase	20 74.1%
White Blood Cell count, Increase to Grade 1	5 18.5%
White Blood Cell count, Increase to Grade 2	7 25.9%
White Blood Cell count, Increase to Grade 3	7 25.9%
White Blood Cell count, Increase to Grade 4	1 3.7%

9. Primary Outcome

Title	Number of Participants With a Decrease in Visual Acuity During Parts 1 and 2
Description	Visual acuity (VA) is defined as acuteness or clearness of vision.
Time Frame	From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)

Outcome Measure Data

Analysis Population Description

Entire Safety Population: all participants in the Pre-antiviral Safety Population

Arm/Group Title	Eltrombopag
Arm/Group Description	In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
Measure Participants	27
Decrease in Visual Acuity, Yes	10 37%
Decrease in Visual Acuity, No	15 55.6%
Decrease in Visual Acuity, Missing or Unknown	2 7.4%

10. Primary Outcome

Title	Number of Participants With the Indicated Change in logMAR Scale Values During Parts 1 and 2
Description	LogMAR (logarithm of the minimum angle of resolution) charts are used to measure an individual's visual acuity. LogMAR, expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30), converts the geometric sequence of a traditional chart to a linear scale. As there are 5 letters per line, the total score for a line on the LogMAR chart represents a change of 0.1 log units.
Time Frame	From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)

Outcome Measure Data

Analysis Population Description

Entire Safety Population

Arm/Group Title	Eltrombopag
Arm/Group Description	In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
Measure Participants	27
logMAR Changes, <0.10 (No Change or Improvement)	15 55.6%
logMAR Changes, >=0.10 to <0.20 (Loss of 1 Line)	6 22.2%
logMAR Changes, >=0.20 to <0.30 (Loss of 2 Lines)	3 11.1%
logMAR Changes, >=0.30 (Loss of 3 Lines or more)	1 3.7%
logMAR Changes, Missing or Unknown	2 7.4%

11. Primary Outcome

Title	Number of Participants With a logMAR Change >=0.15 During Parts 1 and 2
Description	LogMAR (logarithm of the minimum angle of resolution) charts are used to measure an individual's visual acuity. LogMAR, expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30), converts the geometric sequence of a traditional chart to a linear scale. As there are 5 letters per line, the total score for a line on the LogMAR chart represents a change of 0.1 log units.
Time Frame	From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)

Outcome Measure Data

Analysis Population Description

Entire Safety Population

Arm/Group Title	Eltrombopag
Arm/Group Description	In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
Measure Participants	27
logMAR change, Yes	4 14.8%
logMAR change, No	21 77.8%
logMAR change, Missing or Unknown	2 7.4%

12. Secondary Outcome

Title	Number of Participants Achieving Antiviral Treatment Milestones of Sustained Virological Response (SVR), Rapid Virological Response (RVR), Early Virological Response (EVR), and End of Treatment Response (ETR)
Description	SVR is defined as non-detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of the planned treatment period (i.e., Week 48 or 72 for genotype 2/3 or Week 72 for non-genotype 2/3). RVR is defined as undetectable HCV RNA after 4 weeks of antiviral treatment. EVR is defined as clinically significant reduction in HCV RNA (>=2 log10 drop or undetectable) after 12 weeks of antiviral treatment. ETR is defined as undetectable HCV RNA at the end of antiviral treatment.
Time Frame	From the start of investigational product in Part 2 up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)

Outcome Measure Data

Analysis Population Description

Antiviral Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Antiviral Safety Population.

Arm/Group Title	Eltrombopag
Arm/Group Description	In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
Measure Participants	25
SVR, Yes, n=17	4 14.8%
SVR, No, n=17	13 48.1%
RVR, Yes, n=12	3 11.1%
RVR, No, n=12	9 33.3%
EVR, Yes, n=15	15 55.6%
EVR, No, n=15	0 0%
ETR, Yes, n=21	9 33.3%
ETR, No, n=21	12 44.4%

Adverse Events

Time Frame	Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of the 24-week follow up period (up to Week 96/WD).
Arm/Group Title	Eltrombopag (Part 1)		Eltrombopag (Part 2)
Arm/Group Description	In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study.		Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
All Cause Mortality
	Eltrombopag (Part 1)		Eltrombopag (Part 2)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Eltrombopag (Part 1)		Eltrombopag (Part 2)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		5/25 (20%)
Blood and lymphatic system disorders
Thrombocytopenia	0/27 (0%)		1/25 (4%)
Gastrointestinal disorders
Upper gastrointestinal haemorrhage	0/27 (0%)		1/25 (4%)
Infections and infestations
Cellulitis	0/27 (0%)		1/25 (4%)
Metabolism and nutrition disorders
Metabolic disorder	0/27 (0%)		1/25 (4%)
Nervous system disorders
Hepatic encephalopathy	0/27 (0%)		1/25 (4%)
Myoclonic epilepsy	0/27 (0%)		1/25 (4%)
Other (Not Including Serious) Adverse Events
	Eltrombopag (Part 1)		Eltrombopag (Part 2)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/27 (33.3%)		25/25 (100%)
Blood and lymphatic system disorders
Anaemia	1/27 (3.7%)		6/25 (24%)
Neutropenia	1/27 (3.7%)		3/25 (12%)
Leukopenia	0/27 (0%)		7/25 (28%)
Thrombocytopenia	0/27 (0%)		4/25 (16%)
Lymphadenopathy	0/27 (0%)		1/25 (4%)
Lymphopenia	0/27 (0%)		1/25 (4%)
Eye disorders
Vision blurred	0/27 (0%)		2/25 (8%)
Cataract	0/27 (0%)		1/25 (4%)
Conjunctival haemorrhage	0/27 (0%)		1/25 (4%)
Eye discharge	0/27 (0%)		1/25 (4%)
Retinal exudates	0/27 (0%)		1/25 (4%)
Retinal haemorrhage	0/27 (0%)		1/25 (4%)
Retinopathy	0/27 (0%)		1/25 (4%)
Visual acuity reduced	0/27 (0%)		1/25 (4%)
Gastrointestinal disorders
Nausea	2/27 (7.4%)		7/25 (28%)
Abdominal distension	1/27 (3.7%)		1/25 (4%)
Abdominal pain lower	1/27 (3.7%)		2/25 (8%)
Abdominal pain upper	1/27 (3.7%)		3/25 (12%)
Constipation	1/27 (3.7%)		0/25 (0%)
Dry mouth	1/27 (3.7%)		2/25 (8%)
Flatulence	1/27 (3.7%)		1/25 (4%)
Varices oesophageal	1/27 (3.7%)		0/25 (0%)
Diarrhoea	0/27 (0%)		4/25 (16%)
Vomiting	0/27 (0%)		4/25 (16%)
Ascites	0/27 (0%)		3/25 (12%)
Haematemesis	0/27 (0%)		2/25 (8%)
Abdominal discomfort	0/27 (0%)		1/25 (4%)
Abdominal pain	0/27 (0%)		1/25 (4%)
Dyspepsia	0/27 (0%)		1/25 (4%)
Faeces discoloured	0/27 (0%)		1/25 (4%)
Gastrooesophageal reflux disease	0/27 (0%)		1/25 (4%)
Hypertrophy of tongue papillae	0/27 (0%)		1/25 (4%)
Mouth ulceration	0/27 (0%)		1/25 (4%)
Upper gastrointestinal haemorrhage	0/27 (0%)		1/25 (4%)
General disorders
Asthenia	1/27 (3.7%)		5/25 (20%)
Pyrexia	0/27 (0%)		9/25 (36%)
Fatigue	0/27 (0%)		7/25 (28%)
Influenza like illness	0/27 (0%)		5/25 (20%)
Chills	0/27 (0%)		3/25 (12%)
Irritability	0/27 (0%)		2/25 (8%)
Oedema	0/27 (0%)		2/25 (8%)
Oedema peripheral	0/27 (0%)		2/25 (8%)
Chest pain	0/27 (0%)		1/25 (4%)
Injection site erythema	0/27 (0%)		1/25 (4%)
Injection site pruritus	0/27 (0%)		1/25 (4%)
Malaise	0/27 (0%)		1/25 (4%)
Hepatobiliary disorders
Hepatic pain	0/27 (0%)		1/25 (4%)
Immune system disorders
Drug hypersensitivity	1/27 (3.7%)		0/25 (0%)
Infections and infestations
Nasopharyngitis	1/27 (3.7%)		2/25 (8%)
Viral rhinitis	1/27 (3.7%)		0/25 (0%)
Urinary tract infection	0/27 (0%)		4/25 (16%)
Upper respiratory tract infection	0/27 (0%)		3/25 (12%)
Candidiasis	0/27 (0%)		2/25 (8%)
Cellulitis	0/27 (0%)		1/25 (4%)
Ear infection	0/27 (0%)		1/25 (4%)
Furuncle	0/27 (0%)		1/25 (4%)
Gastroenteritis	0/27 (0%)		1/25 (4%)
Influenza	0/27 (0%)		1/25 (4%)
Localised infection	0/27 (0%)		1/25 (4%)
Oral herpes	0/27 (0%)		1/25 (4%)
Rhinitis	0/27 (0%)		1/25 (4%)
Urinary tract infection bacterial	0/27 (0%)		1/25 (4%)
Injury, poisoning and procedural complications
Contusion	0/27 (0%)		1/25 (4%)
Investigations
Blood bilirubin increased	1/27 (3.7%)		0/25 (0%)
Haemoglobin decreased	0/27 (0%)		1/25 (4%)
Weight decreased	0/27 (0%)		1/25 (4%)
White blood cell count decreased	0/27 (0%)		1/25 (4%)
Metabolism and nutrition disorders
Hyperglycaemia	0/27 (0%)		2/25 (8%)
Decreased appetite	0/27 (0%)		1/25 (4%)
Hyperkalaemia	0/27 (0%)		1/25 (4%)
Hypoglycaemia	0/27 (0%)		1/25 (4%)
Metabolic disorder	0/27 (0%)		1/25 (4%)
Musculoskeletal and connective tissue disorders
Pain in extremity	1/27 (3.7%)		1/25 (4%)
Back pain	0/27 (0%)		4/25 (16%)
Arthralgia	0/27 (0%)		1/25 (4%)
Bursitis	0/27 (0%)		1/25 (4%)
Flank pain	0/27 (0%)		1/25 (4%)
Muscular weakness	0/27 (0%)		1/25 (4%)
Musculoskeletal pain	0/27 (0%)		1/25 (4%)
Myalgia	0/27 (0%)		1/25 (4%)
Nervous system disorders
Headache	2/27 (7.4%)		7/25 (28%)
Parkinsonism	1/27 (3.7%)		0/25 (0%)
Hepatic encephalopathy	0/27 (0%)		2/25 (8%)
Disturbance in attention	0/27 (0%)		1/25 (4%)
Dizziness	0/27 (0%)		1/25 (4%)
Dysgeusia	0/27 (0%)		1/25 (4%)
Hyperaesthesia	0/27 (0%)		1/25 (4%)
Lethargy	0/27 (0%)		1/25 (4%)
Myoclonic epilepsy	0/27 (0%)		1/25 (4%)
Nervousness	0/27 (0%)		1/25 (4%)
Psychiatric disorders
Anxiety	1/27 (3.7%)		0/25 (0%)
Insomnia	0/27 (0%)		3/25 (12%)
Sleep disorder	0/27 (0%)		2/25 (8%)
Aggression	0/27 (0%)		1/25 (4%)
Anger	0/27 (0%)		1/25 (4%)
Confusional state	0/27 (0%)		1/25 (4%)
Depressed mood	0/27 (0%)		1/25 (4%)
Depression	0/27 (0%)		1/25 (4%)
Mood swings	0/27 (0%)		1/25 (4%)
Renal and urinary disorders
Haematuria	0/27 (0%)		2/25 (8%)
Nephrolithiasis	0/27 (0%)		1/25 (4%)
Nocturia	0/27 (0%)		1/25 (4%)
Pollakiuria	0/27 (0%)		1/25 (4%)
Reproductive system and breast disorders
Testicular pain	0/27 (0%)		2/25 (8%)
Respiratory, thoracic and mediastinal disorders
Cough	2/27 (7.4%)		3/25 (12%)
Nasal congestion	1/27 (3.7%)		1/25 (4%)
Sneezing	1/27 (3.7%)		0/25 (0%)
Oropharyngeal pain	0/27 (0%)		3/25 (12%)
Epistaxis	0/27 (0%)		2/25 (8%)
Dyspnoea	0/27 (0%)		1/25 (4%)
Dyspnoea exertional	0/27 (0%)		1/25 (4%)
Productive cough	0/27 (0%)		1/25 (4%)
Sinus congestion	0/27 (0%)		1/25 (4%)
Skin and subcutaneous tissue disorders
Pruritus	0/27 (0%)		4/25 (16%)
Dry skin	0/27 (0%)		3/25 (12%)
Alopecia	0/27 (0%)		2/25 (8%)
Blister	0/27 (0%)		1/25 (4%)
Erythema	0/27 (0%)		1/25 (4%)
Rash	0/27 (0%)		1/25 (4%)
Skin hyperpigmentation	0/27 (0%)		1/25 (4%)
Skin ulcer	0/27 (0%)		1/25 (4%)
Night sweats	1/27 (3.7%)		0/25 (0%)
Vascular disorders
Haematoma	0/27 (0%)		2/25 (8%)
Pallor	0/27 (0%)		1/25 (4%)
Phlebitis	0/27 (0%)		1/25 (4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.