Phase III Trial of BI 201335 (Faldaprevir) in Treatment Naive (TN) and Relapser Hepatitis C Virus (HCV)-Human Immunodeficiency Virus (HIV) Coinfected Patients (STARTverso 4)
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT01399619
Collaborator
(none)
310
71
3
33
4.4
0.1
Study Details
Study Description
Brief Summary
the aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 24-48 weeks, according to re-randomisation of Early Treatment Success (ETS) patients at 24 weeks to stop PegIFN/RBV or continue PegIFN/RBV until week 48. If no ETS, then PegIFN/RB for 48 weeks, in HCV treatment-naive or relapsers patients coinfected with HIV
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
310 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety and Efficacy of 120mg and 240mg BI 201335 Once Daily in Combination With Pegylated Interferon Alpha and Ribavirin for Treatment of Chronic Hepatitis C (HCV) Genotype 1 Infection in HIV/HCV Co-infected Patients. A Multinational, Randomised, Parallel Group, Open-label Trial.
Study Start Date
:
Sep 1, 2011
Actual Primary Completion Date
:
Sep 1, 2013
Actual Study Completion Date
:
Jun 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BI201335 12W patient to receive two capsules of BI 201335 once a day for 12 weeks and pegIFN/RBV for 24 or 48 weeks |
Drug: PegIFN/RBV
PegIFN/RBV for 24 or 48w
Drug: BI201335
BI201335 for 12w
|
| Experimental: BI 201335 24W patient to receive two capsules of BI 201335 once a day for 24 weeks and PegIFN/RBV for 24 or 48 weeks |
Drug: BI201335 24W
BI201335 for 24w
Drug: PegIFN/RBV
PegIFN/RBV for 24 or 48w
|
| Experimental: BI 201335 24 W patient to receive one capsule of BI 201335 once a day for 24 weeks and pegIFN/RBV for 24 or 48 weeks |
Drug: PegIFN/RBV
PegIFN/RBV for 24 or 48w
Drug: Bi 201335
BI 201335 for 24 w
|
Outcome Measures
Primary Outcome Measures
- Sustained Virological Response (SVR12) [60 weeks]
Percentage of participants with sustained Virological Response SVR12: Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) level <25 IU/mL, undetected 12 weeks after the planned end of treatment.
Secondary Outcome Measures
- Virological Response 24 Weeks Post Treatment (SVR24) [72 weeks]
Percentage of participants with virological response 24 weeks post treatment (SVR24): Plasma HCV RNA level<25IU/mL (undetected) 24 weeks after the planned end of treatment.
- Early Treatment Success (ETS) [Week 4, week 8 and week 60]
Early Treatment Success (ETS): Plasma HCV RNA level<25 IU/mL (detected or undetected) at Week 4 and HCV RNA< 25 IU/mL, undetected at Week 8
- The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes [48 weeks]
The number of participants with Alanine Aminotransferase (ALT) normalisation at End of Treatment (EoT) when SVR12=yes. BL stands for baseline.
- The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no [48 weeks]
The number of participants with Alanine Aminotransferase (ALT) normalisation: ALT in normal range at End of Treatment when SVR12=no. BL stands for baseline.
- The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes [60 weeks]
The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=yes. BL = baseline.
- The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no [60 weeks]
The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=no. BL = baseline.
- The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes [48 weeks]
The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=yes. BL = baseline.
- The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no [48 weeks]
The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=no. BL = baseline.
- The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes [60 weeks]
The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=yes. BL = baseline.
- The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no [60 weeks]
The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=no. BL = baseline.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:
-
Chronic hepatitis C (HCV) genotype 1 infection
-
Chronic Human Immunodeficiency Virus (HIV) -1 infection
-
HCV treatment naive or HCV treatment experienced but only relapsers
-
Age 18 to 70 years
-
Antiretroviral treatment naive or on stable Highly Active Antiretroviral Therapy (HAART)
-
Karnofsky score >70
-
HCV viral load >1.000 IU/mL
Exclusion criteria:
-
HCV infection of mixed genotype (1/2, 1/3, 1/4)
-
Evidence of acute or chronic liver due to chronic HCV infection
-
Hepatitis B virus (HBV) infection with presence of HBs-Ag
-
Active malignancy or history or malignancy within the last 5 years
-
Received concomitant systemic antiviral (other than antiretroviral), hematopoietic growth factor or immunomodulatory treatment in 28 days prior enrolment.
-
Decompensated liver disease,as evidenced by ascites, hepatic encephalopathy, esophageal variceal bleeding, and/or laboratory values that add up to >/= 7 points according tho the Child-Turcotte-Pugh classification
-
Hemoglobin </=11g/dL for women and </= 12 g/dL for men
-
Patients with stable cardiac disease and Hemoglobin <12g/dL
-
Known hypersensitivity to any ingredient of the study drugs
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 1220.19.0045 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | United States | |
| 2 | 1220.19.0007 Boehringer Ingelheim Investigational Site | Palm Springs | California | United States | |
| 3 | 1220.19.0031 Boehringer Ingelheim Investigational Site | San Francisco | California | United States | |
| 4 | 1220.19.0005 Boehringer Ingelheim Investigational Site | Washington | District of Columbia | United States | |
| 5 | 1220.19.0086 Boehringer Ingelheim Investigational Site | Fort Lauderdale | Florida | United States | |
| 6 | 1220.19.0044 Boehringer Ingelheim Investigational Site | Orlando | Florida | United States | |
| 7 | 1220.19.0004 Boehringer Ingelheim Investigational Site | Vero Beach | Florida | United States | |
| 8 | 1220.19.0079 Boehringer Ingelheim Investigational Site | Lutherville | Maryland | United States | |
| 9 | 1220.19.0027 Boehringer Ingelheim Investigational Site | Framingham | Massachusetts | United States | |
| 10 | 1220.19.0008 Boehringer Ingelheim Investigational Site | Camden | New Jersey | United States | |
| 11 | 1220.19.0009 Boehringer Ingelheim Investigational Site | Hillsborough | New Jersey | United States | |
| 12 | 1220.19.0011 Boehringer Ingelheim Investigational Site | Albany | New York | United States | |
| 13 | 1220.19.0006 Boehringer Ingelheim Investigational Site | New York | New York | United States | |
| 14 | 1220.19.0014 Boehringer Ingelheim Investigational Site | New York | New York | United States | |
| 15 | 1220.19.0084 Boehringer Ingelheim Investigational Site | New York | New York | United States | |
| 16 | 1220.19.0021 Boehringer Ingelheim Investigational Site | Winston-Salem | North Carolina | United States | |
| 17 | 1220.19.0013 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | United States | |
| 18 | 1220.19.0029 Boehringer Ingelheim Investigational Site | Austin | Texas | United States | |
| 19 | 1220.19.0012 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States | |
| 20 | 1220.19.0060 Boehringer Ingelheim Investigational Site | Fort Worth | Texas | United States | |
| 21 | 1220.19.0016 Boehringer Ingelheim Investigational Site | San Antonio | Texas | United States | |
| 22 | 1220.19.0026 Boehringer Ingelheim Investigational Site | Richmond | Virginia | United States | |
| 23 | 1220.19.5502 Boehringer Ingelheim Investigational Site | Rio de Janeiro - RJ | Brazil | ||
| 24 | 1220.19.5508 Boehringer Ingelheim Investigational Site | Rio de Janeiro | Brazil | ||
| 25 | 1220.19.5506 Boehringer Ingelheim Investigational Site | Salvador | Brazil | ||
| 26 | 1220.19.5503 Boehringer Ingelheim Investigational Site | Sao Paulo | Brazil | ||
| 27 | 1220.19.5501 Boehringer Ingelheim Investigational Site | São Paulo - SP | Brazil | ||
| 28 | 1220.19.5505 Boehringer Ingelheim Investigational Site | São Paulo | Brazil | ||
| 29 | 1220.19.3306 Boehringer Ingelheim Investigational Site | Lyon | France | ||
| 30 | 1220.19.3303 Boehringer Ingelheim Investigational Site | Marseille Cedex 08 | France | ||
| 31 | 1220.19.3304 Boehringer Ingelheim Investigational Site | Marseille cedex 9 | France | ||
| 32 | 1220.19.3307 Boehringer Ingelheim Investigational Site | Paris Cedex 12 | France | ||
| 33 | 1220.19.3301 Boehringer Ingelheim Investigational Site | Paris | France | ||
| 34 | 1220.19.3305 Boehringer Ingelheim Investigational Site | Paris | France | ||
| 35 | 1220.19.4902 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 36 | 1220.19.4921 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 37 | 1220.19.4901 Boehringer Ingelheim Investigational Site | Bonn | Germany | ||
| 38 | 1220.19.4924 Boehringer Ingelheim Investigational Site | Frankfurt am Main | Germany | ||
| 39 | 1220.19.4919 Boehringer Ingelheim Investigational Site | Hamburg | Germany | ||
| 40 | 1220.19.4920 Boehringer Ingelheim Investigational Site | Hamburg | Germany | ||
| 41 | 1220.19.4905 Boehringer Ingelheim Investigational Site | München | Germany | ||
| 42 | 1220.19.4922 Boehringer Ingelheim Investigational Site | München | Germany | ||
| 43 | 1220.19.4923 Boehringer Ingelheim Investigational Site | Würzburg | Germany | ||
| 44 | 1220.19.3901 Boehringer Ingelheim Investigational Site | Antella (fi) | Italy | ||
| 45 | 1220.19.3902 Boehringer Ingelheim Investigational Site | Bari | Italy | ||
| 46 | 1220.19.3906 Boehringer Ingelheim Investigational Site | Brescia | Italy | ||
| 47 | 1220.19.3907 Boehringer Ingelheim Investigational Site | Milano | Italy | ||
| 48 | 1220.19.3905 Boehringer Ingelheim Investigational Site | Pavia | Italy | ||
| 49 | 1220.19.3903 Boehringer Ingelheim Investigational Site | Roma | Italy | ||
| 50 | 1220.19.3904 Boehringer Ingelheim Investigational Site | Torino | Italy | ||
| 51 | 1220.19.3404 Boehringer Ingelheim Investigational Site | Badalona | Spain | ||
| 52 | 1220.19.3401 Boehringer Ingelheim Investigational Site | Barcelona | Spain | ||
| 53 | 1220.19.3403 Boehringer Ingelheim Investigational Site | Barcelona | Spain | ||
| 54 | 1220.19.3409 Boehringer Ingelheim Investigational Site | Barcelona | Spain | ||
| 55 | 1220.19.3402 Boehringer Ingelheim Investigational Site | L'Hospitalet de Llobregat | Spain | ||
| 56 | 1220.19.3405 Boehringer Ingelheim Investigational Site | Madrid | Spain | ||
| 57 | 1220.19.3406 Boehringer Ingelheim Investigational Site | Madrid | Spain | ||
| 58 | 1220.19.3407 Boehringer Ingelheim Investigational Site | Madrid | Spain | ||
| 59 | 1220.19.3408 Boehringer Ingelheim Investigational Site | Sevilla | Spain | ||
| 60 | 1220.19.4101 Boehringer Ingelheim Investigational Site | Basel | Switzerland | ||
| 61 | 1220.19.4103 Boehringer Ingelheim Investigational Site | Bern | Switzerland | ||
| 62 | 1220.19.4102 Boehringer Ingelheim Investigational Site | Lugano | Switzerland | ||
| 63 | 1220.19.4104 Boehringer Ingelheim Investigational Site | Zürich | Switzerland | ||
| 64 | 1220.19.4406 Boehringer Ingelheim Investigational Site | Brighton | United Kingdom | ||
| 65 | 1220.19.4407 Boehringer Ingelheim Investigational Site | Edinburgh | United Kingdom | ||
| 66 | 1220.19.4401 Boehringer Ingelheim Investigational Site | London | United Kingdom | ||
| 67 | 1220.19.4402 Boehringer Ingelheim Investigational Site | London | United Kingdom | ||
| 68 | 1220.19.4403 Boehringer Ingelheim Investigational Site | London | United Kingdom | ||
| 69 | 1220.19.4404 Boehringer Ingelheim Investigational Site | London | United Kingdom | ||
| 70 | 1220.19.4408 Boehringer Ingelheim Investigational Site | London | United Kingdom | ||
| 71 | 1220.19.4405 Boehringer Ingelheim Investigational Site | Manchester | United Kingdom |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
- Study Chair: Boehringer Ingelheim, Boehringer Ingelheim
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01399619
Other Study ID Numbers:
- 1220.19
- 2010-021734-59
First Posted:
Jul 22, 2011
Last Update Posted:
Aug 29, 2016
Last Verified:
Jul 1, 2016
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Faldaprevir 120mg -24W | Faldaprevir 240mg -12W | Faldaprevir 240mg-24W | Faldaprevir 240 mg -NR (Prior to Re-randomization at Week 12) |
|---|---|---|---|---|
| Arm/Group Description | Faldaprevir (BI 201335) 120 mg once a day (QD) combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Patients initially assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at WK 12. |
| Period Title: Overall Study | ||||
| STARTED | 123 | 84 | 86 | 17 |
| COMPLETED | 98 | 84 | 74 | 0 |
| NOT COMPLETED | 25 | 0 | 12 | 17 |
Baseline Characteristics
| Arm/Group Title | Faldaprevir 120mg - 24W | Faldaprevir 240mg -T | Total |
|---|---|---|---|
| Arm/Group Description | Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | patient to receive Faldaprevir 240 mg once a day for 12 or 24 weeks and PegIFN/RBV for 24 or 48 weeks + patients who received Faldaprevir 240 mg and discontinued prior to week 12. | Total of all reporting groups |
| Overall Participants | 123 | 185 | 308 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
47.6
(7.63)
|
46.5
(8.36)
|
46.9
(8.08)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
20
16.3%
|
40
21.6%
|
60
19.5%
|
| Male |
103
83.7%
|
145
78.4%
|
248
80.5%
|
Outcome Measures
| Title | Sustained Virological Response (SVR12) |
|---|---|
| Description | Percentage of participants with sustained Virological Response SVR12: Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) level <25 IU/mL, undetected 12 weeks after the planned end of treatment. |
| Time Frame | 60 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Faldaprevir 120mg - 24W | Faldaprevir 240mg - 12W | Faldaprevir 240mg - 24W | Faldaprevir 240mg -T | Faldaprevir - Total |
|---|---|---|---|---|---|
| Arm/Group Description | Faldaprevir 120 mg once a day (QD) combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue BI 201335 to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12. | Total subjects who were treated with Faldaprevir. |
| Measure Participants | 123 | 84 | 86 | 185 | 308 |
| Number (95% Confidence Interval) [percentage of participants] |
70.7
57.5%
|
78.6
42.5%
|
76.7
24.9%
|
72.4
NaN
|
71.8
NaN
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Faldaprevir - Total |
|---|---|---|
| Comments | the SVR12 rate in total Faldaprevir group compared with the historical rate of 40%. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | p-value corresponds to a two sided test against the historical rate of 40%. | |
| Method | normal approximation | |
| Comments | ||
| Title | Virological Response 24 Weeks Post Treatment (SVR24) |
|---|---|
| Description | Percentage of participants with virological response 24 weeks post treatment (SVR24): Plasma HCV RNA level<25IU/mL (undetected) 24 weeks after the planned end of treatment. |
| Time Frame | 72 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Faldaprevir 120mg - 24W | Faldaprevir 240mg - 12W | Faldaprevir 240mg - 24W | Faldaprevir 240mg -T | Faldaprevir - Total |
|---|---|---|---|---|---|
| Arm/Group Description | Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12. | Total subjects who were treated with Faldaprevir. |
| Measure Participants | 123 | 84 | 86 | 185 | 308 |
| Number (95% Confidence Interval) [percentage of participants] |
69.9
56.8%
|
78.6
42.5%
|
74.4
24.2%
|
71.4
NaN
|
70.8
NaN
|
| Title | Early Treatment Success (ETS) |
|---|---|
| Description | Early Treatment Success (ETS): Plasma HCV RNA level<25 IU/mL (detected or undetected) at Week 4 and HCV RNA< 25 IU/mL, undetected at Week 8 |
| Time Frame | Week 4, week 8 and week 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Faldaprevir 120mg - 24W | Faldaprevir 240mg -12W | Faldaprevir 240mg - 24W | Faldaprevir 240mg -T | Faldaprevir - Total |
|---|---|---|---|---|---|
| Arm/Group Description | Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12. | Total subjects who were treated with Faldaprevir. |
| Measure Participants | 123 | 84 | 86 | 185 | 308 |
| number of subjects with ETS =yes |
95
77.2%
|
70
37.8%
|
73
23.7%
|
150
NaN
|
245
NaN
|
| number of subjects with SVR12 among ETS=yes group |
83
67.5%
|
62
33.5%
|
63
20.5%
|
127
NaN
|
210
NaN
|
| Title | The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes |
|---|---|
| Description | The number of participants with Alanine Aminotransferase (ALT) normalisation at End of Treatment (EoT) when SVR12=yes. BL stands for baseline. |
| Time Frame | 48 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Faldaprevir 120mg - 24W | Faldaprevir 240mg - 12W | Faldaprevir 240mg - 24W | Faldaprevir 240mg -T | Faldaprevir - Total |
|---|---|---|---|---|---|
| Arm/Group Description | Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12. | Total subjects who were treated with Faldaprevir. |
| Measure Participants | 123 | 84 | 86 | 185 | 308 |
| SVR12=yes |
87
70.7%
|
66
35.7%
|
66
21.4%
|
134
NaN
|
221
NaN
|
| SVR12=yes, BL normal to EOT normal |
29
23.6%
|
16
8.6%
|
26
8.4%
|
43
NaN
|
72
NaN
|
| SVR12=yes, BL elevated to EOT normal |
45
36.6%
|
34
18.4%
|
32
10.4%
|
66
NaN
|
111
NaN
|
| SVR12=yes, No BL or EoT data |
0
0%
|
0
0%
|
0
0%
|
1
NaN
|
1
NaN
|
| Title | The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no |
|---|---|
| Description | The number of participants with Alanine Aminotransferase (ALT) normalisation: ALT in normal range at End of Treatment when SVR12=no. BL stands for baseline. |
| Time Frame | 48 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Faldaprevir 120mg - 24W | Faldaprevir 240mg -12W | Faldaprevir 240mg - 24W | Faldaprevir 240mg -T | Faldaprevir - Total |
|---|---|---|---|---|---|
| Arm/Group Description | Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12. | Total subjects who were treated with Faldaprevir. |
| Measure Participants | 123 | 84 | 86 | 185 | 308 |
| SVR12=no |
36
29.3%
|
18
9.7%
|
20
6.5%
|
51
NaN
|
87
NaN
|
| SVR12=no, BL normal to EoT normal |
18
14.6%
|
5
2.7%
|
5
1.6%
|
18
NaN
|
36
NaN
|
| SVR12=no, BL elevated to EoT normal |
12
9.8%
|
8
4.3%
|
9
2.9%
|
21
NaN
|
33
NaN
|
| SVR12=no, no BL or EoT data available |
2
1.6%
|
0
0%
|
0
0%
|
0
NaN
|
2
NaN
|
| Title | The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes |
|---|---|
| Description | The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=yes. BL = baseline. |
| Time Frame | 60 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Faldaprevir 120mg -24W | Faldaprevir 240mg -12W | Faldaprevir 240mg - 24W | Faldaprevir 240mg -T | Faldaprevir - Total |
|---|---|---|---|---|---|
| Arm/Group Description | Faldaprevir 120 mg once a day (QD) combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12. | Total subjects who were treated with Faldaprevir. |
| Measure Participants | 123 | 84 | 86 | 185 | 308 |
| SVR12=yes |
87
70.7%
|
66
35.7%
|
66
21.4%
|
134
NaN
|
221
NaN
|
| SVR12=yes, BL normal to SVR12 normal |
28
22.8%
|
17
9.2%
|
26
8.4%
|
45
NaN
|
73
NaN
|
| SVR12=yes, BL elevated to SVR12 normal |
52
42.3%
|
46
24.9%
|
35
11.4%
|
81
NaN
|
133
NaN
|
| SVR12=yes, no ALT data available at SVR12 visit |
4
3.3%
|
0
0%
|
1
0.3%
|
1
NaN
|
5
NaN
|
| Title | The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no |
|---|---|
| Description | The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=no. BL = baseline. |
| Time Frame | 60 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Faldaprevir 120mg - 24W | Faldaprevir 240mg - 12W | Faldaprevir 240mg - 24W | Faldaprevir 240mg -T | Faldaprevir - Total |
|---|---|---|---|---|---|
| Arm/Group Description | Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12. | Total subjects who were treated with Faldaprevir. |
| Measure Participants | 123 | 84 | 86 | 185 | 308 |
| SVR12=no |
36
29.3%
|
18
9.7%
|
20
6.5%
|
51
NaN
|
87
NaN
|
| SVR12=no, BL normal to SVR12 normal |
8
6.5%
|
1
0.5%
|
3
1%
|
6
NaN
|
14
NaN
|
| SVR12=no, BL elevated to SVR12 normal |
1
0.8%
|
6
3.2%
|
3
1%
|
9
NaN
|
10
NaN
|
| SVR12=no, no ALT data available at SVR12 visit |
16
13%
|
4
2.2%
|
6
1.9%
|
20
NaN
|
36
NaN
|
| Title | The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes |
|---|---|
| Description | The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=yes. BL = baseline. |
| Time Frame | 48 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Faldaprevir 120mg - 24W | Faldaprevir 240mg - 12W | Faldaprevir 240mg - 24W | Faldaprevir 240mg -T | Faldaprevir - Total |
|---|---|---|---|---|---|
| Arm/Group Description | Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12. | Total subjects who were treated with Faldaprevir. |
| Measure Participants | 123 | 84 | 86 | 185 | 308 |
| SVR12=yes |
87
70.7%
|
66
35.7%
|
66
21.4%
|
134
NaN
|
221
NaN
|
| SVR12=yes, BL normal to EoT normal |
41
33.3%
|
25
13.5%
|
28
9.1%
|
54
NaN
|
95
NaN
|
| SVR12=yes, BL elevated to EoT normal |
32
26%
|
25
13.5%
|
27
8.8%
|
52
NaN
|
84
NaN
|
| SVR12=yes, no BL or EoT data available |
0
0%
|
0
0%
|
0
0%
|
1
NaN
|
1
NaN
|
| Title | The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no |
|---|---|
| Description | The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=no. BL = baseline. |
| Time Frame | 48 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Faldaprevir 120mg - 24W | Faldaprevir 240mg - 12W | Faldaprevir 240mg - 24W | Faldaprevir 240mg -T | Faldaprevir - Total |
|---|---|---|---|---|---|
| Arm/Group Description | Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12. | Total subjects who were treated with Faldaprevir. |
| Measure Participants | 123 | 84 | 86 | 185 | 308 |
| SVR12=no |
36
29.3%
|
18
9.7%
|
20
6.5%
|
51
NaN
|
87
NaN
|
| SVR12=no, BL normal to EoT normal |
14
11.4%
|
6
3.2%
|
7
2.3%
|
19
NaN
|
33
NaN
|
| SVR12=no, BL elevated to EoT normal |
12
9.8%
|
6
3.2%
|
8
2.6%
|
19
NaN
|
31
NaN
|
| SVR12=no, no BL or EoT data available |
2
1.6%
|
0
0%
|
0
0%
|
0
NaN
|
2
NaN
|
| Title | The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes |
|---|---|
| Description | The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=yes. BL = baseline. |
| Time Frame | 60 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Faldaprevir 120mg - 24W | Faldaprevir 240mg - 12W | Faldaprevir 240mg - 24W | Faldaprevir 240mg -T | Faldaprevir - Total |
|---|---|---|---|---|---|
| Arm/Group Description | Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12. | Total subjects who were treated with Faldaprevir. |
| Measure Participants | 123 | 84 | 86 | 185 | 308 |
| SVR12=yes |
87
70.7%
|
66
35.7%
|
66
21.4%
|
134
NaN
|
221
NaN
|
| SVR12=yes, BL normal to SVR12 normal |
41
33.3%
|
27
14.6%
|
28
9.1%
|
57
NaN
|
98
NaN
|
| SVR12=yes, BL elevated to SVR12 normal |
36
29.3%
|
36
19.5%
|
33
10.7%
|
69
NaN
|
105
NaN
|
| SVR12=yes, no AST data available at SVR12 visit |
4
3.3%
|
0
0%
|
1
0.3%
|
1
NaN
|
5
NaN
|
| Title | The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no |
|---|---|
| Description | The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=no. BL = baseline. |
| Time Frame | 60 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Faldaprevir 120mg - 24W | Faldaprevir 240mg - 12W | Faldaprevir 240mg - 24W | Faldaprevir 240mg -T | Faldaprevir - Total |
|---|---|---|---|---|---|
| Arm/Group Description | Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12. | Total subjects who were treated with Faldaprevir. |
| Measure Participants | 123 | 84 | 86 | 185 | 308 |
| SVR12=no |
36
29.3%
|
18
9.7%
|
20
6.5%
|
51
NaN
|
87
NaN
|
| SVR12=no, BL normal to SVR12 normal |
6
4.9%
|
4
2.2%
|
6
1.9%
|
13
NaN
|
19
NaN
|
| SVR12=no, BL elevated to SVR12 normal |
2
1.6%
|
3
1.6%
|
0
0%
|
3
NaN
|
5
NaN
|
| SVR12=no, no AST data available at SVR12 visit |
16
13%
|
4
2.2%
|
6
1.9%
|
20
NaN
|
36
NaN
|
Adverse Events
| Time Frame | from the start date of trial medication up to 52 weeks ( AEs occurred from the start date of trial medication up to four weeks after all treatment discontinuation). | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Faldaprevir 120mg - 24W | Faldaprevir 240mg - 12W | Faldaprevir 240mg - 24W | Faldaprevir 240mg -T | ||||
| Arm/Group Description | Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. | Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12. | ||||
All Cause Mortality |
||||||||
| Faldaprevir 120mg - 24W | Faldaprevir 240mg - 12W | Faldaprevir 240mg - 24W | Faldaprevir 240mg -T | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Faldaprevir 120mg - 24W | Faldaprevir 240mg - 12W | Faldaprevir 240mg - 24W | Faldaprevir 240mg -T | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 17/123 (13.8%) | 5/84 (6%) | 5/86 (5.8%) | 15/185 (8.1%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 0/123 (0%) | 0/84 (0%) | 1/86 (1.2%) | 2/185 (1.1%) | ||||
| Thrombocytopenia | 0/123 (0%) | 0/84 (0%) | 1/86 (1.2%) | 1/185 (0.5%) | ||||
| Cardiac disorders | ||||||||
| Acute coronary syndrome | 1/123 (0.8%) | 0/84 (0%) | 0/86 (0%) | 0/185 (0%) | ||||
| Acute myocardial infarction | 1/123 (0.8%) | 0/84 (0%) | 0/86 (0%) | 0/185 (0%) | ||||
| Endocrine disorders | ||||||||
| Hyperthyroidism | 0/123 (0%) | 1/84 (1.2%) | 0/86 (0%) | 1/185 (0.5%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal pain | 1/123 (0.8%) | 1/84 (1.2%) | 1/86 (1.2%) | 2/185 (1.1%) | ||||
| Diarrhoea | 0/123 (0%) | 0/84 (0%) | 0/86 (0%) | 1/185 (0.5%) | ||||
| Enterovesical fistula | 0/123 (0%) | 1/84 (1.2%) | 0/86 (0%) | 1/185 (0.5%) | ||||
| Nausea | 0/123 (0%) | 0/84 (0%) | 0/86 (0%) | 1/185 (0.5%) | ||||
| Vomiting | 1/123 (0.8%) | 0/84 (0%) | 0/86 (0%) | 1/185 (0.5%) | ||||
| General disorders | ||||||||
| Asthenia | 1/123 (0.8%) | 0/84 (0%) | 0/86 (0%) | 0/185 (0%) | ||||
| Pyrexia | 3/123 (2.4%) | 0/84 (0%) | 0/86 (0%) | 1/185 (0.5%) | ||||
| Hepatobiliary disorders | ||||||||
| Cholecystitis | 0/123 (0%) | 1/84 (1.2%) | 0/86 (0%) | 1/185 (0.5%) | ||||
| Immune system disorders | ||||||||
| Sarcoidosis | 0/123 (0%) | 0/84 (0%) | 0/86 (0%) | 1/185 (0.5%) | ||||
| Infections and infestations | ||||||||
| Appendicitis | 1/123 (0.8%) | 0/84 (0%) | 0/86 (0%) | 0/185 (0%) | ||||
| Diverticulitis | 0/123 (0%) | 1/84 (1.2%) | 0/86 (0%) | 1/185 (0.5%) | ||||
| Escherichia urinary tract infection | 1/123 (0.8%) | 0/84 (0%) | 0/86 (0%) | 0/185 (0%) | ||||
| Gastroenteritis | 1/123 (0.8%) | 0/84 (0%) | 0/86 (0%) | 0/185 (0%) | ||||
| Gastroenteritis viral | 0/123 (0%) | 1/84 (1.2%) | 0/86 (0%) | 1/185 (0.5%) | ||||
| Infected cyst | 1/123 (0.8%) | 0/84 (0%) | 0/86 (0%) | 0/185 (0%) | ||||
| Leishmaniasis | 0/123 (0%) | 0/84 (0%) | 1/86 (1.2%) | 1/185 (0.5%) | ||||
| Neurosyphilis | 1/123 (0.8%) | 0/84 (0%) | 0/86 (0%) | 0/185 (0%) | ||||
| Pneumonia | 0/123 (0%) | 0/84 (0%) | 0/86 (0%) | 1/185 (0.5%) | ||||
| Pneumonia bacterial | 1/123 (0.8%) | 0/84 (0%) | 0/86 (0%) | 0/185 (0%) | ||||
| Pulmonary tuberculosis | 0/123 (0%) | 0/84 (0%) | 0/86 (0%) | 1/185 (0.5%) | ||||
| Sepsis | 1/123 (0.8%) | 0/84 (0%) | 0/86 (0%) | 0/185 (0%) | ||||
| Urosepsis | 1/123 (0.8%) | 0/84 (0%) | 0/86 (0%) | 0/185 (0%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Accidental overdose | 0/123 (0%) | 0/84 (0%) | 1/86 (1.2%) | 1/185 (0.5%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Decreased appetite | 1/123 (0.8%) | 0/84 (0%) | 0/86 (0%) | 0/185 (0%) | ||||
| Dehydration | 1/123 (0.8%) | 0/84 (0%) | 0/86 (0%) | 1/185 (0.5%) | ||||
| Hypokalaemia | 0/123 (0%) | 0/84 (0%) | 1/86 (1.2%) | 1/185 (0.5%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Lymphoma | 0/123 (0%) | 0/84 (0%) | 0/86 (0%) | 1/185 (0.5%) | ||||
| Nervous system disorders | ||||||||
| Epilepsy | 0/123 (0%) | 1/84 (1.2%) | 0/86 (0%) | 1/185 (0.5%) | ||||
| Renal and urinary disorders | ||||||||
| Nephrolithiasis | 1/123 (0.8%) | 0/84 (0%) | 0/86 (0%) | 0/185 (0%) | ||||
| Reproductive system and breast disorders | ||||||||
| Benign prostatic hyperplasia | 1/123 (0.8%) | 0/84 (0%) | 0/86 (0%) | 0/185 (0%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Drug reaction with eosinophilia and systemic symptoms | 0/123 (0%) | 0/84 (0%) | 0/86 (0%) | 1/185 (0.5%) | ||||
| Rash | 1/123 (0.8%) | 0/84 (0%) | 0/86 (0%) | 1/185 (0.5%) | ||||
| Rash erythematous | 1/123 (0.8%) | 0/84 (0%) | 0/86 (0%) | 0/185 (0%) | ||||
| Rash maculo-papular | 2/123 (1.6%) | 0/84 (0%) | 0/86 (0%) | 0/185 (0%) | ||||
| Toxic skin eruption | 0/123 (0%) | 0/84 (0%) | 0/86 (0%) | 1/185 (0.5%) | ||||
| Social circumstances | ||||||||
| Substance use | 0/123 (0%) | 0/84 (0%) | 0/86 (0%) | 1/185 (0.5%) | ||||
| Vascular disorders | ||||||||
| Haematoma | 1/123 (0.8%) | 0/84 (0%) | 0/86 (0%) | 0/185 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Faldaprevir 120mg - 24W | Faldaprevir 240mg - 12W | Faldaprevir 240mg - 24W | Faldaprevir 240mg -T | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 116/123 (94.3%) | 80/84 (95.2%) | 84/86 (97.7%) | 178/185 (96.2%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 27/123 (22%) | 13/84 (15.5%) | 15/86 (17.4%) | 30/185 (16.2%) | ||||
| Neutropenia | 27/123 (22%) | 6/84 (7.1%) | 15/86 (17.4%) | 22/185 (11.9%) | ||||
| Eye disorders | ||||||||
| Dry eye | 3/123 (2.4%) | 5/84 (6%) | 0/86 (0%) | 6/185 (3.2%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal pain | 7/123 (5.7%) | 11/84 (13.1%) | 4/86 (4.7%) | 17/185 (9.2%) | ||||
| Abdominal pain upper | 7/123 (5.7%) | 7/84 (8.3%) | 3/86 (3.5%) | 10/185 (5.4%) | ||||
| Cheilitis | 8/123 (6.5%) | 4/84 (4.8%) | 3/86 (3.5%) | 7/185 (3.8%) | ||||
| Diarrhoea | 31/123 (25.2%) | 24/84 (28.6%) | 23/86 (26.7%) | 51/185 (27.6%) | ||||
| Dry mouth | 6/123 (4.9%) | 5/84 (6%) | 2/86 (2.3%) | 7/185 (3.8%) | ||||
| Dyspepsia | 6/123 (4.9%) | 4/84 (4.8%) | 7/86 (8.1%) | 11/185 (5.9%) | ||||
| Nausea | 34/123 (27.6%) | 38/84 (45.2%) | 36/86 (41.9%) | 81/185 (43.8%) | ||||
| Vomiting | 12/123 (9.8%) | 14/84 (16.7%) | 23/86 (26.7%) | 43/185 (23.2%) | ||||
| General disorders | ||||||||
| Asthenia | 31/123 (25.2%) | 21/84 (25%) | 17/86 (19.8%) | 39/185 (21.1%) | ||||
| Chills | 5/123 (4.1%) | 2/84 (2.4%) | 7/86 (8.1%) | 11/185 (5.9%) | ||||
| Fatigue | 39/123 (31.7%) | 29/84 (34.5%) | 30/86 (34.9%) | 65/185 (35.1%) | ||||
| Influenza like illness | 14/123 (11.4%) | 17/84 (20.2%) | 12/86 (14%) | 31/185 (16.8%) | ||||
| Injection site reaction | 3/123 (2.4%) | 2/84 (2.4%) | 6/86 (7%) | 8/185 (4.3%) | ||||
| Irritability | 19/123 (15.4%) | 8/84 (9.5%) | 5/86 (5.8%) | 13/185 (7%) | ||||
| Pyrexia | 29/123 (23.6%) | 11/84 (13.1%) | 10/86 (11.6%) | 24/185 (13%) | ||||
| Hepatobiliary disorders | ||||||||
| Jaundice | 7/123 (5.7%) | 8/84 (9.5%) | 10/86 (11.6%) | 19/185 (10.3%) | ||||
| Infections and infestations | ||||||||
| Oral herpes | 8/123 (6.5%) | 0/84 (0%) | 2/86 (2.3%) | 2/185 (1.1%) | ||||
| Investigations | ||||||||
| Weight decreased | 16/123 (13%) | 10/84 (11.9%) | 13/86 (15.1%) | 25/185 (13.5%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Decreased appetite | 29/123 (23.6%) | 14/84 (16.7%) | 18/86 (20.9%) | 36/185 (19.5%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 11/123 (8.9%) | 6/84 (7.1%) | 6/86 (7%) | 13/185 (7%) | ||||
| Muscle spasms | 3/123 (2.4%) | 3/84 (3.6%) | 6/86 (7%) | 9/185 (4.9%) | ||||
| Myalgia | 17/123 (13.8%) | 9/84 (10.7%) | 15/86 (17.4%) | 27/185 (14.6%) | ||||
| Nervous system disorders | ||||||||
| Dizziness | 9/123 (7.3%) | 10/84 (11.9%) | 6/86 (7%) | 20/185 (10.8%) | ||||
| Headache | 29/123 (23.6%) | 21/84 (25%) | 22/86 (25.6%) | 47/185 (25.4%) | ||||
| Lethargy | 1/123 (0.8%) | 3/84 (3.6%) | 5/86 (5.8%) | 8/185 (4.3%) | ||||
| Psychiatric disorders | ||||||||
| Anxiety | 9/123 (7.3%) | 5/84 (6%) | 2/86 (2.3%) | 8/185 (4.3%) | ||||
| Depressed mood | 6/123 (4.9%) | 4/84 (4.8%) | 7/86 (8.1%) | 12/185 (6.5%) | ||||
| Depression | 11/123 (8.9%) | 9/84 (10.7%) | 13/86 (15.1%) | 24/185 (13%) | ||||
| Insomnia | 29/123 (23.6%) | 11/84 (13.1%) | 14/86 (16.3%) | 28/185 (15.1%) | ||||
| Sleep disorder | 4/123 (3.3%) | 3/84 (3.6%) | 5/86 (5.8%) | 8/185 (4.3%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Cough | 13/123 (10.6%) | 8/84 (9.5%) | 10/86 (11.6%) | 18/185 (9.7%) | ||||
| Dyspnoea | 12/123 (9.8%) | 8/84 (9.5%) | 3/86 (3.5%) | 12/185 (6.5%) | ||||
| Oropharyngeal pain | 3/123 (2.4%) | 6/84 (7.1%) | 2/86 (2.3%) | 9/185 (4.9%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Alopecia | 7/123 (5.7%) | 4/84 (4.8%) | 6/86 (7%) | 10/185 (5.4%) | ||||
| Dry skin | 17/123 (13.8%) | 9/84 (10.7%) | 18/86 (20.9%) | 27/185 (14.6%) | ||||
| Erythema | 8/123 (6.5%) | 5/84 (6%) | 5/86 (5.8%) | 10/185 (5.4%) | ||||
| Night sweats | 7/123 (5.7%) | 6/84 (7.1%) | 3/86 (3.5%) | 9/185 (4.9%) | ||||
| Pruritus | 19/123 (15.4%) | 16/84 (19%) | 17/86 (19.8%) | 34/185 (18.4%) | ||||
| Rash | 22/123 (17.9%) | 16/84 (19%) | 13/86 (15.1%) | 31/185 (16.8%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Results Point of Contact
| Name/Title | Boehringer Ingelheim Call Center |
|---|---|
| Organization | Boehringer Ingelheim |
| Phone | 1-800-243-0127 |
| clintriage.rdg@boehringer-ingelheim.com |
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01399619
Other Study ID Numbers:
- 1220.19
- 2010-021734-59
First Posted:
Jul 22, 2011
Last Update Posted:
Aug 29, 2016
Last Verified:
Jul 1, 2016