Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)
Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00828750
Collaborator
(none)
19
6
1
33.1
3.2
0.1
Study Details
Study Description
Brief Summary
An open-label, dose-adjustment extension study to evaluate the safety and efficacy of eltrombopag for treatment of subjects with ITP who have previously been enrolled in the eltrombopag trial TRA108109 (NCT00540423).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
19 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)-An Extension Study of Eltrombopag in Subjects, With Idiopathic Thrombocytopenic Purpura (ITP), Previously Enrolled in an Eltrombopag Study TRA108109 (NCT00540423)-<Phase III Study>
Study Start Date
:
May 1, 2008
Actual Primary Completion Date
:
Feb 1, 2011
Actual Study Completion Date
:
Feb 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment Eltrombopag oral tablets once daily |
Drug: Eltrombopag oral tablets
Eltrombopag oral tablets once daily
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category [From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)]
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medical product, whether or not related to the product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or its prolongation, results in disability/incapacity, is a congenital anomaly/birth defect, or is another event considered serious. A drug-related AE is any AE that was judged to have a relationship with the study medication by the investigator. The severity of an AE is based on the investigator's clinical judgment.
Secondary Outcome Measures
- Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L [Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)]
Platelet counts were measured by blood draw.
- Median Platelet Counts [Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)]
Platelet counts were measured by blood draw.
- Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.) [From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)]
Maximum continuous week (MCW) is measured as the longest period (weeks) for which a participant continuously maintained platelet counts greater than or equal to 50 Gi/L and greater than or equal to twice the Baseline count.
- Median Number of Maximum Continuous Weeks of Maintaining Platelet Counts Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count at Three-Month Intervals [3, 6, 9, 12, 15, 18, 21, 24, 27, and 30 months (13, 26, 39, 52, 65, 78, 91, 104, 117, and 130 weeks)]
Maximum continuous week is measured as the longest period (weeks) for which a participant continuously maintained platelet counts greater than or equal to 50 Gi/L and greater than or equal to twice the Baseline count.
- Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication [Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)]
Any bleeding(s) with an onset on or after the start date of study medication was recorded as a bleeding episode(s).
- Percentage of Participants With a Reduction in Use of Baseline Idiopathic Thrombocytopenic Purpura (ITP) Medication [From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)]
Concomitant ITP medications included drugs such as steroids and immunosuppressive drugs. Reduction of concomitant ITP medication was defined as a reduction in dose and/or frequency of administration.
- Percentage of Participants Initiating Rescue Medication/Treatment During On-Therapy [From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)]
Rescue therapy included new ITP medication, an increased dose of a concomitant ITP medication from Baseline (B/L), platelet transfusion, and splenectomy.
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subject has signed and dated written informed consent.
-
Subject (>=20 years) diagnosed with ITP.
-
Subject previously enrolled in TRA108109 (NCT00540423) must have completed the treatment and follow-up periods as defined in that protocol.
-
Subject has no intercurrent medical event at risk of thrombosis such as thrombophilia.
-
Prolongation of prothrombin time and activated partial thromboplastin time (aPTT) must be within 1.2 times the upper limit of the normal range with no history of hypercoagulable state.
-
A complete blood count (CBC), within the reference range, with the following exceptions:
-
Hemoglobin: patients with haemoglobin level < the lower limit of normal are eligible for inclusion if hemorrhage is present.
-
Neutrophil count >= 1,500/L (1.5x10E9/L) is required for inclusion.
-
The following clinical chemistries MUST NOT exceed 1.2 times the upper limit of the normal reference range: creatinine, total bilirubin and alkaline phosphatase.
-
The following clinical chemistries MUST NOT exceed 2 times the upper limit of the normal reference range: ALT and AST.
-
Albumin must be not less than 80% of the lower limit of normal.
-
Female subjects must either be:
-
of non-childbearing potential (hysterectomy, bilateral oophorectomy, bilateral tubal ligation or post-menopausal > 1 year), or
-
of childbearing potential and have a negative pregnancy test and agree to use contraceptive methods specified in the GSK List of Highly Effective Methods for Avoidance of Pregnancy from two weeks prior to administration of study medication, throughout the study, and 28 days after completion or premature discontinuation from the study:
-
Reticulocyte count within the reference range or elevated in case of bleeding.
Exclusion Criteria:
-
Any severe medical condition (cardiac, hepatic or renal disorder) other than chronic ITP. (Note: "Severe" is defined as >= Grade 3 as a rule according to the "Classification of the Severity of Adverse Experiences (PAB/SD Notification No.80, dated 29 June 1992)
-
History of suspected or confirmed arterial or venous thrombosis (e.g., myocardial infarction, deep vein thrombosis) within the last 1 year.
-
History of drug/alcohol abuse or dependence within the last 1 year.
-
Suspected blood disorder other than ITP.
-
Suspected platelet aggregation abnormality.
-
Suspected cyclic thrombocytopenia.
-
Suspected Evans Syndrome.
-
Subjects who met the GSK Liver Stopping Criteria in the previous eltrombopag study TRA108109 (NCT00540423).
-
Current or history of HIV infection or hepatitis B virus or hepatitis C virus infections.
-
Current malignancy or history of malignancy that was treated with chemotherapy or radiotherapy.
-
Female subjects who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
-
Subjects who are deemed unsuitable for the study by the investigator (or subinvestigator).
-
Treatment with an investigational drug within 30 days preceding the first dose of study medication.
-
Pre-existing cardiovascular disease, or arrhythmia known to increase the risk of thromboembolic events (e.g. atrial fibrillation).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Gifu | Japan | 503-8502 | |
| 2 | GSK Investigational Site | Hiroshima | Japan | 734-8551 | |
| 3 | GSK Investigational Site | Ibaraki | Japan | 305-8576 | |
| 4 | GSK Investigational Site | Osaka | Japan | 565-0871 | |
| 5 | GSK Investigational Site | Osaka | Japan | 596-8501 | |
| 6 | GSK Investigational Site | Tokyo | Japan | 160-8582 |
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:
NCT00828750
Other Study ID Numbers:
- 111433
First Posted:
Jan 26, 2009
Last Update Posted:
Sep 17, 2018
Last Verified:
Oct 1, 2011
Keywords provided by GlaxoSmithKline
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | This study is an open-label, dose-adjustment extension study to evaluate the safety and efficacy of eltrombopag for the treatment of participants with idiopathic thrombocytopenic purpura (ITP) who had previously been enrolled in eltrombopag trial TRA108109 (NCT00540423). |
| Arm/Group Title | Eltrombopag |
|---|---|
| Arm/Group Description | Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count (PC) at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment. |
| Period Title: Overall Study | |
| STARTED | 19 |
| COMPLETED | 15 |
| NOT COMPLETED | 4 |
Baseline Characteristics
| Arm/Group Title | Eltrombopag |
|---|---|
| Arm/Group Description | Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment. |
| Overall Participants | 19 |
| Age (Years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Years] |
54.7
(13.57)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
12
63.2%
|
| Male |
7
36.8%
|
| Race/Ethnicity, Customized (participants) [Number] | |
| Asian - Japanese Heritage |
19
100%
|
Outcome Measures
| Title | Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category |
|---|---|
| Description | An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medical product, whether or not related to the product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or its prolongation, results in disability/incapacity, is a congenital anomaly/birth defect, or is another event considered serious. A drug-related AE is any AE that was judged to have a relationship with the study medication by the investigator. The severity of an AE is based on the investigator's clinical judgment. |
| Time Frame | From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population (SP): all participants who received at least one dose of study medication |
| Arm/Group Title | Eltrombopag |
|---|---|
| Arm/Group Description | Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment. |
| Measure Participants | 19 |
| AE |
19
100%
|
| SAE |
6
31.6%
|
| Drug-Related AE |
5
26.3%
|
| AE Leading to Withdrawal |
0
0%
|
| SAE Leading to Withdrawal |
0
0%
|
| Ongoing AE at the End of Study/Withdrawal |
15
78.9%
|
| Mild AE |
6
31.6%
|
| Moderate AE |
13
68.4%
|
| Severe AE |
0
0%
|
| Title | Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L |
|---|---|
| Description | Platelet counts were measured by blood draw. |
| Time Frame | Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS): all participants with the exception of those who did not receive any dose of study medication and those with no valid measurements of platelet count on therapy. The number of participants analyzed varies by week because some participants prematurely withdrew and the timing of the measurement differs among participants. |
| Arm/Group Title | Eltrombopag |
|---|---|
| Arm/Group Description | Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment. |
| Measure Participants | 19 |
| Baseline, n=19 |
5.3
27.9%
|
| Week 1, n=19 |
21.1
111.1%
|
| Week 2, n=19 |
63.2
332.6%
|
| Week 3, n=19 |
78.9
415.3%
|
| Week 4, n=19 |
73.7
387.9%
|
| Week 8, n=19 |
73.7
387.9%
|
| Week 12, n=16 |
68.8
362.1%
|
| Week 16, n=17 |
76.5
402.6%
|
| Week 20, n=15 |
73.3
385.8%
|
| Week 24, n=17 |
82.4
433.7%
|
| Week 28, n=16 |
81.3
427.9%
|
| Week 32, n=16 |
68.8
362.1%
|
| Week 36, n=18 |
66.7
351.1%
|
| Week 40, n=17 |
47.1
247.9%
|
| Week 44, n=17 |
58.8
309.5%
|
| Week 48, n=18 |
83.3
438.4%
|
| Week 52, n=16 |
62.5
328.9%
|
| Week 56, n=14 |
57.1
300.5%
|
| Week 60, n=16 |
50.0
263.2%
|
| Week 64, n=14 |
57.1
300.5%
|
| Week 68, n=14 |
57.1
300.5%
|
| Week 72, n=12 |
50.0
263.2%
|
| Week 76, n=12 |
75.0
394.7%
|
| Week 80, n=12 |
66.7
351.1%
|
| Week 84, n=13 |
69.2
364.2%
|
| Week 88, n=12 |
75.0
394.7%
|
| Week 92, n=11 |
72.7
382.6%
|
| Week 96, n=11 |
54.5
286.8%
|
| Week 100, n=13 |
46.2
243.2%
|
| Week 104, n=11 |
45.5
239.5%
|
| Week 108, n=11 |
72.7
382.6%
|
| Week 112, n=7 |
57.1
300.5%
|
| Week 116, n=7 |
85.7
451.1%
|
| Week 120, n=5 |
40.0
210.5%
|
| Week 124, n=6 |
16.7
87.9%
|
| Week 128, n=4 |
25.0
131.6%
|
| Week 132, n=2 |
50.0
263.2%
|
| Week 136, n=1 |
100
526.3%
|
| Last Visit/Early Withdrawal Visit, n=19 |
57.9
304.7%
|
| Title | Median Platelet Counts |
|---|---|
| Description | Platelet counts were measured by blood draw. |
| Time Frame | Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS. The number of participants analyzed varies by week because some participants prematurely withdrew and the timing of the measurement differs among participants. |
| Arm/Group Title | Eltrombopag |
|---|---|
| Arm/Group Description | Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment. |
| Measure Participants | 19 |
| Baseline, n=19 |
20.0
|
| Week 1, n=19 |
36.0
|
| Week 2, n=19 |
84.0
|
| Week 3, n=19 |
85.0
|
| Week 4, n=19 |
97.0
|
| Week 8, n=19 |
102.0
|
| Week 12, n=16 |
85.0
|
| Week 16, n=17 |
76.0
|
| Week 20, n=15 |
61.0
|
| Week 24, n=17 |
70.0
|
| Week 28, n=16 |
97.0
|
| Week 32, n=16 |
75.0
|
| Week 36, n=18 |
73.5
|
| Week 40, n=17 |
45.0
|
| Week 44, n=17 |
59.0
|
| Week 48, n=18 |
71.5
|
| Week 52, n=16 |
81.0
|
| Week 56, n=14 |
58.0
|
| Week 60, n=16 |
48.5
|
| Week 64, n=14 |
57.5
|
| Week 68, n=14 |
53.5
|
| Week 72, n=12 |
51.5
|
| Week 76, n=12 |
90.0
|
| Week 80, n=12 |
67.5
|
| Week 84, n=13 |
86.0
|
| Week 88, n=12 |
65.0
|
| Week 92, n=11 |
78.0
|
| Week 96, n=11 |
57.0
|
| Week 100, n=13 |
45.0
|
| Week 104, n=11 |
44.0
|
| Week 108, n=11 |
69.0
|
| Week 112, n=7 |
56.0
|
| Week 116, n=7 |
84.0
|
| Week 120, n=5 |
21.0
|
| Week 124, n=6 |
32.0
|
| Week 128, n=4 |
37.0
|
| Week 132, n=2 |
34.0
|
| Week 136, n=1 |
51.0
|
| Last Visit/Early Withdrawal Visit, n=19 |
75.0
|
| Title | Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.) |
|---|---|
| Description | Maximum continuous week (MCW) is measured as the longest period (weeks) for which a participant continuously maintained platelet counts greater than or equal to 50 Gi/L and greater than or equal to twice the Baseline count. |
| Time Frame | From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS. The number of participants analyzed varies by category of weeks on study medication because the duration of study medication differs among participants. |
| Arm/Group Title | Eltrombopag |
|---|---|
| Arm/Group Description | Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment. |
| Measure Participants | 19 |
| Study Med. =<52 weeks (WKS), MCW=0 week (WK), n=2 |
0
0%
|
| Study Med. =<52 WKS, MCW >=1 WK, n=2 |
100
526.3%
|
| Study Med. =<52 WKS, MCW >=4 WKS, n=2 |
100
526.3%
|
| Study Med. =<52 WKS, MCW >=7 WKS, n=2 |
50.0
263.2%
|
| Study Med. =<52 WKS, MCW >=10 WKS, n=2 |
50.0
263.2%
|
| Study Med. =<52 WKS, MCW >=13 WKS, n=2 |
50.0
263.2%
|
| Study Med. =<52 WKS, MCW >=16 WKS, n=2 |
50.0
263.2%
|
| Study Med. =<52 WKS, MCW >=19 WKS, n=2 |
50.0
263.2%
|
| Study Med. =<52 WKS, MCW >=22 WKS, n=2 |
50.0
263.2%
|
| Study Med. =<52 WKS, MCW >=25 WKS, n=2 |
50.0
263.2%
|
| Study Med. =<52 WKS, MCW >=28 WKS, n=2 |
50.0
263.2%
|
| Study Med. =<52 WKS, MCW >=31 WKS, n=2 |
50.0
263.2%
|
| Study Med. =<52 WKS, MCW >=34 WKS, n=2 |
50.0
263.2%
|
| Study Med. =<52 WKS, MCW >=37 WKS, n=2 |
0
0%
|
| Study Med. =<52 WKS, MCW >=40 WKS, n=2 |
0
0%
|
| Study Med. =<52 WKS, MCW >=43 WKS, n=2 |
0
0%
|
| Study Med. >52 to =<78 WKS, MCW=0 WK, n=1 |
0
0%
|
| Study Med. >52 to =<78 WKS, MCW >=1 WK, n=1 |
100
526.3%
|
| Study Med. >52 to =<78 WKS, MCW >=4 WKS, n=1 |
100
526.3%
|
| Study Med. >52 to =<78 WKS, MCW >=7 WKS, n=1 |
100
526.3%
|
| Study Med. >52 to =<78 WKS, MCW >=10 WKS, n=1 |
0
0%
|
| Study Med. >52 to =<78 WKS, MCW >=13 WKS, n=1 |
0
0%
|
| Study Med. >52 to =<78 WKS, MCW >=16 WKS, n=1 |
0
0%
|
| Study Med. >52 to =<78 WKS, MCW >=19 WKS, n=1 |
0
0%
|
| Study Med. >52 to =<78 WKS, MCW >=22 WKS, n=1 |
0
0%
|
| Study Med. >52 to =<78 WKS, MCW >=25 WKS, n=1 |
0
0%
|
| Study Med. >52 to =<78 WKS, MCW >=28 WKS, n=1 |
0
0%
|
| Study Med. >52 to =<78 WKS, MCW >=31 WKS, n=1 |
0
0%
|
| Study Med. >52 to =<78 WKS, MCW >=34 WKS, n=1 |
0
0%
|
| Study Med. >52 to =<78 WKS, MCW >=37 WKS, n=1 |
0
0%
|
| Study Med. >52 to =<78 WKS, MCW >=40 WKS, n=1 |
0
0%
|
| Study Med. >52 to =<78 WKS, MCW >=43 WKS, n=1 |
0
0%
|
| Study Med. >52 to =<78 WKS, MCW >=52 WKS, n=1 |
0
0%
|
| Study Med. >52 to =<78 WKS, MCW >=65 WKS, n=1 |
0
0%
|
| Study Med. >78 to =<104 WKS, MCW=0 WK, n=1 |
0
0%
|
| Study Med. >78 to =<104 WKS, MCW >=1 WK, n=1 |
100
526.3%
|
| Study Med. >78 to =<104 WKS, MCW >=4 WKS, n=1 |
100
526.3%
|
| Study Med. >78 to =<104 WKS, MCW >=7 WKS, n=1 |
100
526.3%
|
| Study Med. >78 to =<104 WKS, MCW >=10 WKS, n=1 |
100
526.3%
|
| Study Med. >78 to =<104 WKS, MCW >=13 WKS, n=1 |
100
526.3%
|
| Study Med. >78 to =<104 WKS, MCW >=16 WKS, n=1 |
100
526.3%
|
| Study Med. >78 to =<104 WKS, MCW >=19 WKS, n=1 |
100
526.3%
|
| Study Med. >78 to =<104 WKS, MCW >=22 WKS, n=1 |
100
526.3%
|
| Study Med. >78 to =<104 WKS, MCW >=25 WKS, n=1 |
100
526.3%
|
| Study Med. >78 to =<104 WKS, MCW >=28 WKS, n=1 |
100
526.3%
|
| Study Med. >78 to =<104 WKS, MCW >=31 WKS, n=1 |
100
526.3%
|
| Study Med. >78 to =<104 WKS, MCW >=34 WKS, n=1 |
100
526.3%
|
| Study Med. >78 to =<104 WKS, MCW >=37 WKS, n=1 |
100
526.3%
|
| Study Med. >78 to =<104 WKS, MCW >=40 WKS, n=1 |
100
526.3%
|
| Study Med. >78 to =<104 WKS, MCW >=43 WKS, n=1 |
0
0%
|
| Study Med. >78 to =<104 WKS, MCW >=52 WKS, n=1 |
0
0%
|
| Study Med. >78 to =<104 WKS, MCW >=65 WKS, n=1 |
0
0%
|
| Study Med. >78 to =<104 WKS, MCW >=78 WKS, n=1 |
0
0%
|
| Study Med. >104 to =<130 WKS, MCW=0 WK, n=11 |
0
0%
|
| Study Med. >104 to =<130 WKS, MCW >=1 WK, n=11 |
100
526.3%
|
| Study Med. >104 to =<130 WKS, MCW >=4 WKS, n=11 |
90.9
478.4%
|
| Study Med. >104 to =<130 WKS, MCW >=7 WKS, n=11 |
90.9
478.4%
|
| Study Med. >104 to =<130 WKS, MCW >=10 WKS, n=11 |
90.9
478.4%
|
| Study Med. >104 to =<130 WKS, MCW >=13 WKS, n=11 |
90.9
478.4%
|
| Study Med. >104 to =<130 WKS, MCW >=16 WKS, n=11 |
81.8
430.5%
|
| Study Med. >104 to =<130 WKS, MCW >=19 WKS, n=11 |
63.6
334.7%
|
| Study Med. >104 to =<130 WKS, MCW >=22 WKS, n=11 |
54.5
286.8%
|
| Study Med. >104 to =<130 WKS, MCW >=25 WKS, n=11 |
45.5
239.5%
|
| Study Med. >104 to =<130 WKS, MCW >=28 WKS, n=11 |
45.5
239.5%
|
| Study Med. >104 to =<130 WKS, MCW >=31 WKS, n=11 |
36.4
191.6%
|
| Study Med. >104 to =<130 WKS, MCW >=34 WKS, n=11 |
36.4
191.6%
|
| Study Med. >104 to =<130 WKS, MCW >=37 WKS, n=11 |
18.2
95.8%
|
| Study Med. >104 to =<130 WKS, MCW >=40 WKS, n=11 |
18.2
95.8%
|
| Study Med. >104 to =<130 WKS, MCW >=43 WKS, n=11 |
18.2
95.8%
|
| Study Med. >104 to =<130 WKS, MCW >=52 WKS, n=11 |
18.2
95.8%
|
| Study Med. >104 to =<130 WKS, MCW >=65 WKS, n=11 |
9.1
47.9%
|
| Study Med. >104 to =<130 WKS, MCW >=78 WKS, n=11 |
9.1
47.9%
|
| Study Med. >104 to =<130 WKS, MCW >=91 WKS, n=11 |
9.1
47.9%
|
| Study Med. >104 to =<130 WKS, MCW >=104 WKS, n=11 |
0
0%
|
| Study Med. >104 to =<130 WKS, MCW >=117 WKS, n=6 |
0
0%
|
| Study Med. >130 WKS, MCW=0 WK, n=4 |
0
0%
|
| Study Med. >130 WKS, MCW >=1 WK, n=4 |
100
526.3%
|
| Study Med. >130 WKS, MCW >=4 WKS, n=4 |
50.0
263.2%
|
| Study Med. >130 WKS, MCW >=7 WKS, n=4 |
50.0
263.2%
|
| Study Med. >130 WKS, MCW >=10 WKS, n=4 |
50.0
263.2%
|
| Study Med. >130 WKS, MCW >=13 WKS, n=4 |
25.0
131.6%
|
| Study Med. >130 WKS, MCW >=16 WKS, n=4 |
25.0
131.6%
|
| Study Med. >130 WKS, MCW >=19 WKS, n=4 |
25.0
131.6%
|
| Study Med. >130 WKS, MCW >=22 WKS, n=4 |
25.0
131.6%
|
| Study Med. >130 WKS, MCW >=25 WKS, n=4 |
25.0
131.6%
|
| Study Med. >130 WKS, MCW >=28 WKS, n=4 |
25.0
131.6%
|
| Study Med. >130 WKS, MCW >=31 WKS, n=4 |
25.0
131.6%
|
| Study Med. >130 WKS, MCW >=34 WKS, n=4 |
25.0
131.6%
|
| Study Med. >130 WKS, MCW >=37 WKS, n=4 |
25.0
131.6%
|
| Study Med. >130 WKS, MCW >=40 WKS, n=4 |
25.0
131.6%
|
| Study Med. >130 WKS, MCW >=43 WKS, n=4 |
0
0%
|
| Study Med. >130 WKS, MCW >=52 WKS, n=4 |
0
0%
|
| Study Med. >130 WKS, MCW >=65 WKS, n=4 |
0
0%
|
| Study Med. >130 WKS, MCW >=78 WKS, n=4 |
0
0%
|
| Study Med. >130 WKS, MCW >=91 WKS, n=4 |
0
0%
|
| Study Med. >130 WKS, MCW >=104 WKS, n=4 |
0
0%
|
| Study Med. >130 WKS, MCW >=117 WKS, n=4 |
0
0%
|
| Total, MCW=0 WK, n=19 |
0
0%
|
| Total, MCW >=1 WK, n=19 |
100
526.3%
|
| Total, MCW >=4 WKS, n=19 |
84.2
443.2%
|
| Total, MCW >=7 WKS, n=19 |
78.9
415.3%
|
| Total, MCW >=10 WKS, n=19 |
73.7
387.9%
|
| Total, MCW >=13 WKS, n=19 |
68.4
360%
|
| Total, MCW >=16 WKS, n=19 |
63.2
332.6%
|
| Total, MCW >=19 WKS, n=19 |
52.6
276.8%
|
| Total, MCW >=22 WKS, n=19 |
47.4
249.5%
|
| Total, MCW >=25 WKS, n=19 |
42.1
221.6%
|
| Total, MCW >=28 WKS, n=19 |
42.1
221.6%
|
| Total, MCW >=31 WKS, n=19 |
36.8
193.7%
|
| Total, MCW >=34 WKS, n=19 |
36.8
193.7%
|
| Total, MCW >=37 WKS, n=19 |
21.1
111.1%
|
| Total, MCW >=40 WKS, n=19 |
21.1
111.1%
|
| Total, MCW >=43 WKS, n=19 |
10.5
55.3%
|
| Total, MCW >=52 WKS, n=17 |
11.8
62.1%
|
| Total, MCW >=65 WKS, n=17 |
5.9
31.1%
|
| Total, MCW >=78 WKS, n=16 |
6.3
33.2%
|
| Total, MCW >=91 WKS, n=15 |
6.7
35.3%
|
| Total, MCW >=104 WKS, n=15 |
0
0%
|
| Total, MCW >=117 WKS, n=10 |
0
0%
|
| Title | Median Number of Maximum Continuous Weeks of Maintaining Platelet Counts Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count at Three-Month Intervals |
|---|---|
| Description | Maximum continuous week is measured as the longest period (weeks) for which a participant continuously maintained platelet counts greater than or equal to 50 Gi/L and greater than or equal to twice the Baseline count. |
| Time Frame | 3, 6, 9, 12, 15, 18, 21, 24, 27, and 30 months (13, 26, 39, 52, 65, 78, 91, 104, 117, and 130 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS. The number of participants analyzed varies by category of months (weeks) on study medication because the duration of study medication differs among participants. |
| Arm/Group Title | Eltrombopag |
|---|---|
| Arm/Group Description | Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment. |
| Measure Participants | 19 |
| Total, n=19 |
19.0
|
| 3 Months (13 Weeks), n=18 |
5.0
|
| 6 Months (26 Weeks), n=19 |
10.0
|
| 9 Months (39 Weeks), n=19 |
12.0
|
| 12 Months (52 Weeks), n=17 |
14.0
|
| 15 Months (65 Weeks), n=17 |
14.0
|
| 18 Months (78 Weeks), n=16 |
15.0
|
| 21 Months (91 Weeks), n=15 |
14.0
|
| 24 Months (104 Weeks), n=15 |
19.0
|
| 27 Months (117 Weeks), n=10 |
17.5
|
| 30 Months (130 Weeks), n=4 |
7.5
|
| Title | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication |
|---|---|
| Description | Any bleeding(s) with an onset on or after the start date of study medication was recorded as a bleeding episode(s). |
| Time Frame | Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS. The number of participants analyzed varies by week because some participants prematurely withdrew and the timing of the evaluation differs among participants. |
| Arm/Group Title | Eltrombopag |
|---|---|
| Arm/Group Description | Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment. |
| Measure Participants | 19 |
| Baseline, n=19 |
63
331.6%
|
| Week 1, n=19 |
32
168.4%
|
| Week 2, n=19 |
21
110.5%
|
| Week 3, n=19 |
16
84.2%
|
| Week 4, n=19 |
5
26.3%
|
| Week 8, n=19 |
11
57.9%
|
| Week 12, n=16 |
13
68.4%
|
| Week 16, n=17 |
12
63.2%
|
| Week 20, n=15 |
40
210.5%
|
| Week 24, n=17 |
6
31.6%
|
| Week 28, n=16 |
25
131.6%
|
| Week 32, n=16 |
19
100%
|
| Week 36, n=18 |
39
205.3%
|
| Week 40, n=17 |
35
184.2%
|
| Week 44, n=17 |
24
126.3%
|
| Week 48, n=18 |
22
115.8%
|
| Week 52, n=16 |
31
163.2%
|
| Week 56, n=14 |
29
152.6%
|
| Week 60, n=16 |
13
68.4%
|
| Week 64, n=14 |
21
110.5%
|
| Week 68, n=14 |
29
152.6%
|
| Week 72, n=12 |
8
42.1%
|
| Week 76, n=12 |
8
42.1%
|
| Week 80, n=12 |
25
131.6%
|
| Week 84, n=13 |
0
0%
|
| Week 88, n=12 |
8
42.1%
|
| Week 92, n=11 |
9
47.4%
|
| Week 96, n=11 |
9
47.4%
|
| Week 100, n=13 |
8
42.1%
|
| Week 104, n=11 |
27
142.1%
|
| Week 108, n=11 |
27
142.1%
|
| Week 112, n=7 |
14
73.7%
|
| Week 116, n=7 |
0
0%
|
| Week 120, n=5 |
0
0%
|
| Week 124, n=6 |
33
173.7%
|
| Week 128, n=4 |
25
131.6%
|
| Week 132, n=2 |
50
263.2%
|
| Week 136, n=1 |
0
0%
|
| Last Visit/Early Withdrawal, n=19 |
21
110.5%
|
| Title | Percentage of Participants With a Reduction in Use of Baseline Idiopathic Thrombocytopenic Purpura (ITP) Medication |
|---|---|
| Description | Concomitant ITP medications included drugs such as steroids and immunosuppressive drugs. Reduction of concomitant ITP medication was defined as a reduction in dose and/or frequency of administration. |
| Time Frame | From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS. A total of 15 participants who received at least one concomitant ITP medication at Baseline were included in the analysis. |
| Arm/Group Title | Eltrombopag |
|---|---|
| Arm/Group Description | Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment. |
| Measure Participants | 15 |
| Number [percentage of participants] |
87
457.9%
|
| Title | Percentage of Participants Initiating Rescue Medication/Treatment During On-Therapy |
|---|---|
| Description | Rescue therapy included new ITP medication, an increased dose of a concomitant ITP medication from Baseline (B/L), platelet transfusion, and splenectomy. |
| Time Frame | From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Eltrombopag |
|---|---|
| Arm/Group Description | Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment. |
| Measure Participants | 19 |
| Any Rescue Therapy |
21
110.5%
|
| New ITP Medication |
11
57.9%
|
| Increase in Concomitant ITP Medication from B/L |
11
57.9%
|
| Platelet Transfusion |
0
0%
|
| Splenectomy |
0
0%
|
Adverse Events
| Time Frame | Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days). | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Eltrombopag | |
| Arm/Group Description | Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment. | |
All Cause Mortality |
||
| Eltrombopag | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Eltrombopag | ||
| Affected / at Risk (%) | # Events | |
| Total | 6/19 (31.6%) | |
| Eye disorders | ||
| Cataract | 2/19 (10.5%) | |
| Gastrointestinal disorders | ||
| Abdominal pain | 1/19 (5.3%) | |
| Mallory-Weiss syndrome | 1/19 (5.3%) | |
| Musculoskeletal and connective tissue disorders | ||
| Lumbar spinal stenosis | 1/19 (5.3%) | |
| Osteonecrosis | 1/19 (5.3%) | |
| Spinal osteoarthritis | 1/19 (5.3%) | |
| Renal and urinary disorders | ||
| Cystitis-like symptom | 1/19 (5.3%) | |
| Reproductive system and breast disorders | ||
| Menorrhagia | 1/19 (5.3%) | |
Other (Not Including Serious) Adverse Events |
||
| Eltrombopag | ||
| Affected / at Risk (%) | # Events | |
| Total | 19/19 (100%) | |
| Blood and lymphatic system disorders | ||
| Iron deficiency anaemia | 3/19 (15.8%) | |
| Anaemia | 2/19 (10.5%) | |
| Idiopathic thrombocytopenic purpura | 1/19 (5.3%) | |
| Ear and labyrinth disorders | ||
| Presbyacusis | 1/19 (5.3%) | |
| Eye disorders | ||
| Cataract | 2/19 (10.5%) | |
| Asthenopia | 1/19 (5.3%) | |
| Chalazion | 1/19 (5.3%) | |
| Conjunctival haemorrhage | 1/19 (5.3%) | |
| Conjunctivitis | 1/19 (5.3%) | |
| Conjunctivitis allergic | 1/19 (5.3%) | |
| Eye pruritus | 1/19 (5.3%) | |
| Vision blurred | 1/19 (5.3%) | |
| Gastrointestinal disorders | ||
| Diarrhoea | 3/19 (15.8%) | |
| Abdominal pain lower | 1/19 (5.3%) | |
| Dental caries | 1/19 (5.3%) | |
| Food poisoning | 1/19 (5.3%) | |
| Gastric ulcer | 1/19 (5.3%) | |
| Gastritis | 1/19 (5.3%) | |
| Gastritis atrophic | 1/19 (5.3%) | |
| Gastritis erosive | 1/19 (5.3%) | |
| Haemorrhoids | 1/19 (5.3%) | |
| Reflux oesophagitis | 1/19 (5.3%) | |
| Tongue discolouration | 1/19 (5.3%) | |
| Toothache | 1/19 (5.3%) | |
| Vomiting | 1/19 (5.3%) | |
| General disorders | ||
| Chest pain | 2/19 (10.5%) | |
| Fatigue | 2/19 (10.5%) | |
| Pyrexia | 2/19 (10.5%) | |
| Chills | 1/19 (5.3%) | |
| Oedema | 1/19 (5.3%) | |
| Infections and infestations | ||
| Nasopharyngitis | 12/19 (63.2%) | |
| Bronchitis | 3/19 (15.8%) | |
| Cystitis | 2/19 (10.5%) | |
| Influenza | 2/19 (10.5%) | |
| Cellulitis | 1/19 (5.3%) | |
| Fungal infection | 1/19 (5.3%) | |
| Parotitis | 1/19 (5.3%) | |
| Pharyngitis | 1/19 (5.3%) | |
| Rhinitis | 1/19 (5.3%) | |
| Sinusitis | 1/19 (5.3%) | |
| Tinea infection | 1/19 (5.3%) | |
| Injury, poisoning and procedural complications | ||
| Compression fracture | 2/19 (10.5%) | |
| Excoriation | 1/19 (5.3%) | |
| Lip injury | 1/19 (5.3%) | |
| Procedural pain | 1/19 (5.3%) | |
| Upper limb fracture | 1/19 (5.3%) | |
| Investigations | ||
| Aspartate aminotransferase increased | 2/19 (10.5%) | |
| Alanine aminotransferase increased | 1/19 (5.3%) | |
| Glucose urine present | 1/19 (5.3%) | |
| Haemoglobin decreased | 1/19 (5.3%) | |
| Metabolism and nutrition disorders | ||
| Hyperglycaemia | 1/19 (5.3%) | |
| Metabolic disorder | 1/19 (5.3%) | |
| Musculoskeletal and connective tissue disorders | ||
| Myalgia | 3/19 (15.8%) | |
| Tenosynovitis | 2/19 (10.5%) | |
| Arthralgia | 1/19 (5.3%) | |
| Intervertebral disc protrusion | 1/19 (5.3%) | |
| Osteoarthritis | 1/19 (5.3%) | |
| Periarthritis | 1/19 (5.3%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Lip neoplasm | 1/19 (5.3%) | |
| Nervous system disorders | ||
| Headache | 4/19 (21.1%) | |
| Hypoaesthesia | 1/19 (5.3%) | |
| Psychiatric disorders | ||
| Insomnia | 3/19 (15.8%) | |
| Reproductive system and breast disorders | ||
| Genital haemorrhage | 1/19 (5.3%) | |
| Uterine prolapse | 1/19 (5.3%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Oropharyngeal pain | 2/19 (10.5%) | |
| Rhinitis allergic | 1/19 (5.3%) | |
| Upper respiratory tract inflammation | 1/19 (5.3%) | |
| Skin and subcutaneous tissue disorders | ||
| Eczema | 3/19 (15.8%) | |
| Dry skin | 1/19 (5.3%) | |
| Heat rash | 1/19 (5.3%) | |
| Papule | 1/19 (5.3%) | |
| Pruritus | 1/19 (5.3%) | |
| Seborrhoeic dermatitis | 1/19 (5.3%) | |
| Urticaria | 1/19 (5.3%) | |
| Vascular disorders | ||
| Hypertension | 3/19 (15.8%) | |
| Hot flush | 1/19 (5.3%) | |
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.
Results Point of Contact
| Name/Title | GSK Response Center |
|---|---|
| Organization | GlaxoSmithKline |
| Phone | 866-435-7343 |
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00828750
Other Study ID Numbers:
- 111433
First Posted:
Jan 26, 2009
Last Update Posted:
Sep 17, 2018
Last Verified:
Oct 1, 2011