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Trial record 2 of 28 for:    RNA | BI 201335 OR faldaprevir

A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients

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ClinicalTrials.gov Identifier: NCT01330316
Recruitment Status : Completed
First Posted : April 6, 2011
Results First Posted : July 31, 2015
Last Update Posted : June 30, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: BI 201335
Drug: PegIFN/RBV
Enrollment 119
Recruitment Details This was a multi-national, open-label trial enrolling two cohorts of patients with chronic Hepatitis C Virus (HCV) infection of genotype 1 (GT-1) who were randomized to the placebo arm (+ Pegylated interferon α-2a/ Ribavirin) and experienced virologic failure in one of the 1220.7 (NCT01358864), 1220.30 (NCT01343888), 1220.47 (NCT01297270) trials.
Pre-assignment Details Eligible patients who entered the rollover trial within 14 weeks of their last study visit in one of the predecessor trials were not required to do a screening visit (treatment start: Day 1). Eligible patients who were outside of this 14-week window were required to do a screening visit (Visit 1) and started treatment at Visit 2 (Day 1).
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Faldaprevir (FDV) 240 mg once daily combined with Pegylated interferon α-2a (PegIFN)/ Ribavirin (RBV) for 24 weeks was administered for relapser patients.

At week 24, patients who did not achieve early treatment success (ETS) continue with an additional 24 weeks of PegIFN/RBV.

ETS is defined as Hepatitis C virus(HCV) Ribonucleic Acid (RNA) <25 Internalional Units (IU)/millilitre (ml) (detected or undetected) at week 4 and <25 IU/ml (undetected) at week 8.

Patients who had undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels at the end of treatment in one of the previous studies (see recruitment details) but had detectable levels in subsequent assessments are called relapser.

Faldaprevir (FDV) 240mg once daily combined with Pegylated interferon α-2a (PegIFN)/ Ribavirin (RBV) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV for non-relapser patients.

Non-relapser are non-responder (null and partial) and breakthrough patients. Null responders are patients who did not achieve > 2 log10 decrease in HCV RNA from baseline during the treatment period.

Partial non-responders are patients who achieved > 2 log10 decrease in HCV RNA from baseline but who never achieved an undetectable level of HCV RNA.

Breakthrough are patients who achieved an undetectable HCV RNA during the treatment period but had detectable HCV RNA at the end of treatment.

Period Title: Overall Study
Started 43 75
Completed 41 60
Not Completed 2 15
Reason Not Completed
Adverse Event             2             2
Lack of Efficacy             0             10
Lost to Follow-up             0             1
Withdrawal by Subject             0             1
other than above             0             1
Arm/Group Title Relapse Non-relapse Total
Hide Arm/Group Description FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV. FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV. Total of all reporting groups
Overall Number of Baseline Participants 43 75 118
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Full analysis set (FAS): This set included all patients who entered the trial, were dispensed study medication, and were documented to have taken at least one dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 75 participants 118 participants
55.4  (7.38) 53.4  (9.46) 54.1  (8.78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 75 participants 118 participants
Female
16
  37.2%
25
  33.3%
41
  34.7%
Male
27
  62.8%
50
  66.7%
77
  65.3%
1.Primary Outcome
Title Sustained Virological Response (SVR): Plasma HCV RNA Level < 25 IU/mL
Hide Description The primary endpoint was SVR12, defined as a plasma Hepatitis C virus (HCV) Ribonucleic acid (RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.
Time Frame 12 weeks post treatment, up to 60 weeks
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FAS
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FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
Overall Number of Participants Analyzed 43 75
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
95.3
(89.1 to 100)
54.7
(43.4 to 65.9)
2.Secondary Outcome
Title Sustained Virological Response After 24 Weeks of Treatment Discontinuation (SVR24)
Hide Description Sustained virologic response 24 weeks, defined as a plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.
Time Frame 24 weeks post treatment, up to 72 weeks
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FAS
Arm/Group Title Relapse Non-relapse
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FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
Overall Number of Participants Analyzed 43 75
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
95.3
(89.1 to 100.0)
54.7
(43.4 to 65.9)
3.Secondary Outcome
Title Early Treatment Success (ETS)
Hide Description ETS, defined as a 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 and week 8
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FAS
Arm/Group Title Relapse Non-relapse
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FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
Overall Number of Participants Analyzed 43 75
Measure Type: Number
Unit of Measure: percentage of participants
97.7 65.3
4.Secondary Outcome
Title Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT)
Hide Description This will be presented as the number of patients in/not in normal range from baseline EoT. SVR12 is sustained virological response 12 weeks post-treatment.
Time Frame Week 24 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers
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FAS
Arm/Group Title Relapse Non-relapse
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FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
Overall Number of Participants Analyzed 43 75
Measure Type: Number
Unit of Measure: participants
SVR12 = Yes 41 41
SVR12 = Yes, Baseline Normal to EOT Normal 12 10
SVR12 = Yes, Baseline Elevated to EOT Normal 16 15
SVR12 = No 2 34
SVR12 = No, Baseline Normal to EOT Normal 0 11
SVR12 = No, Baseline Elevated to EOT Normal 2 9
5.Secondary Outcome
Title Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at 12 Weeks Post-treatment.
Hide Description This will be presented as the number of patients in/not in normal range from baseline to 12 weeks post treatment. SVR12 is sustained virological response 12 weeks post-treatment.
Time Frame 48 weeks for relapsers with ETS; 60 weeks for non-relapsers and relapsers without ETS
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FAS
Arm/Group Title Relapse Non-relapse
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FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
Overall Number of Participants Analyzed 43 75
Measure Type: Number
Unit of Measure: participants
SVR12 = Yes 41 41
SVR12 = Yes, Baseline Normal to SVR12 Normal 12 11
SVR12 = Yes, Baseline Elevated to SVR12 Normal 27 27
SVR12 = No 2 34
SVR12 = No, Baseline Normal to SVR12 Normal 0 8
SVR12 = No, Baseline Elevated to SVR12 Normal 1 2
6.Secondary Outcome
Title Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT)
Hide Description This will be presented as the number of patients in/not in normal range from baseline to EoT. SVR12 is sustained virological response 12 weeks post-treatment.
Time Frame Week 24 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers.
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FAS
Arm/Group Title Relapse Non-relapse
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FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
Overall Number of Participants Analyzed 43 75
Measure Type: Number
Unit of Measure: participants
SVR12 = Yes 41 41
SVR12 = Yes, Baseline Normal to EOT Normal 15 13
SVR12 = Yes, Baseline Elevated to EOT Normal 14 11
SVR12 = No 2 34
SVR12 = No, Baseline Normal to EOT Normal 1 12
SVR12 = No, Baseline Elevated to EOT Normal 1 7
7.Secondary Outcome
Title Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at 12 Weeks Post-treatment.
Hide Description This will be presented as the number of patients in/not in normal range from baseline to 12 weeks post treatment. SVR12 is sustained virological response 12 weeks post-treatment.
Time Frame Week 48 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers
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FAS
Arm/Group Title Relapse Non-relapse
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FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
Overall Number of Participants Analyzed 43 75
Measure Type: Number
Unit of Measure: participants
SVR12 = Yes 41 41
SVR12 = Yes, Baseline Normal to SVR12 Normal 15 14
SVR12 = Yes, Baseline Elevated to SVR12 Normal 22 24
SVR12 = No 2 34
SVR12 = No, Baseline Normal to SVR12 Normal 1 10
SVR12 = No, Baseline Elevated to SVR12 Normal 0 3
8.Secondary Outcome
Title Occurrence of Adverse Events (Overall and by DAIDS Grade)
Hide Description

This outcome measure will be presented as the percentage of subjects with any adverse event (AE).

Percentages are calculated using total number of subjects per treatment cohort as the denominator.

The intensity of all AEs was evaluated according to the DAIDS (Division of Acquired Immunodeficiency Syndrome) grading scale with AEs of mild, moderate, or severe intensity receiving Grades 1, 2, or 3, respectively. Adverse events judged potentially life threatening received a Grade 4 assessment.

Time Frame from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days
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FAS
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FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
Overall Number of Participants Analyzed 43 75
Measure Type: Number
Unit of Measure: percentage of participants
Overall 90.7 93.3
Subjects with DAIDS Grade 2, 3 or 4 AEs 65.1 56.0
Subjects with DAIDS Grade 3 or 4 AEs 27.9 17.3
Subjects with DAIDS Grade 4 AEs 7.0 1.3
9.Secondary Outcome
Title Occurrence of Adverse Events Leading to Treatment Discontinuation
Hide Description This outcome measure will be presented as the percentage of subjects with adverse events leading to discontinuation of Faldaprevir and all study medication. Percentages are calculated using total number of subjects per treatment cohort as the denominator.
Time Frame from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days
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FAS
Arm/Group Title Relapse Non-relapse
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FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
Overall Number of Participants Analyzed 43 75
Measure Type: Number
Unit of Measure: percentage of participants
discontinuation of faldaprevir 4.7 2.7
discontinuation of all study medication 2.3 0.0
10.Secondary Outcome
Title Occurrence of Serious Adverse Events (SAEs)
Hide Description This outcome measure will be presented as the percentage of subjects with any serious adverse event (SAE). Percentages are calculated using total number of subjects per treatment cohort as the denominator.
Time Frame from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days
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FAS
Arm/Group Title Relapse Non-relapse
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FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
Overall Number of Participants Analyzed 43 75
Measure Type: Number
Unit of Measure: percentage of participants
2.3 8.0
11.Secondary Outcome
Title Occurrence of Drug-related AEs as Assessed by the Investigator
Hide Description This outcome measure will be presented as the percentage of subjects with any drug-related AEs as assessed by the investigator. Percentages are calculated using total number of subjects per treatment cohort as the denominator.
Time Frame from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days
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FAS
Arm/Group Title Relapse Non-relapse
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FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
Overall Number of Participants Analyzed 43 75
Measure Type: Number
Unit of Measure: percentage of participants
88.4 88.0
12.Secondary Outcome
Title Laboratory Test Abnormalities by DAIDS Grades
Hide Description This Outcome measure will be presented as summary of the percentage of patients with worst on-treatment Division of Acquired Immunodeficiency Syndrome (DAIDS) grade laboratory abnormalities for selected analytes (Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total) with particular relevance to patients with HCV.
Time Frame baseline (day 1, after first dose of randomised treatment) up to 7 days after the last intake of study
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FAS
Arm/Group Title Relapse Non-relapse
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FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
Overall Number of Participants Analyzed 43 75
Measure Type: Number
Unit of Measure: percentage of participants
Haemoglobin, Grade 2 14.0 18.9
Haemoglobin, Grade 3 11.6 8.1
Haemoglobin, Grade 4 0.0 0.0
ALT, Grade 2 7.0 6.7
ALT, Grade 3 2.3 4.0
ALT, Grade 4 2.3 0.0
AST, Grade 2 4.7 10.7
AST, Grade 3 2.3 2.7
AST, Grade 4 2.3 0.0
Bilirubin, total, Grade 2 32.6 37.3
Bilirubin, total, Grade 3 39.5 29.3
Bilirubin, total, Grade 4 11.6 13.3
13.Secondary Outcome
Title Changes From Baseline in Laboratory Test Values Over Time [Haemoglobin]
Hide Description

This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total.

In this outcome measure Haemoglobin is presented.

Time Frame baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)
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FAS
Arm/Group Title Relapse Non-relapse
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FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
Overall Number of Participants Analyzed 43 75
Mean (Standard Deviation)
Unit of Measure: gram (g)/decilitre (dL)
Baseline (N=43, 74) 14.8  (1.3) 14.8  (1.4)
week 4 (N=41, 69) 12.6  (1.6) 12.7  (1.4)
week 12 (N=43, 66) 11.7  (1.6) 11.5  (1.5)
min value on treatment (N=43, 74) 11.1  (1.5) 11.3  (1.7)
max value on treatment (N=43, 74) 13.7  (1.2) 14.0  (1.4)
last value on treatment (N=43, 74) 11.4  (1.5) 11.8  (1.6)
14.Secondary Outcome
Title Changes From Baseline in Laboratory Test Values Over Time [ALT]
Hide Description

This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total.

In this outcome measure ALT is presented.

Time Frame baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)
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FAS
Arm/Group Title Relapse Non-relapse
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FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
Overall Number of Participants Analyzed 43 75
Mean (Standard Deviation)
Unit of Measure: Units (U)/Litre (L)
Baseline (N=43, 75) 72  (79) 88  (63)
week 4 (N=43, 73) 51  (71) 57  (49)
week 12 (N=43, 67) 43  (40) 55  (62)
min value on treatment (N=43, 75) 30  (20) 39  (38)
max value on treatment (N=43, 75) 68  (91) 70  (62)
last value on treatment (N=43, 75) 40  (26) 54  (52)
15.Secondary Outcome
Title Changes From Baseline in Laboratory Test Values Over Time [AST]
Hide Description

This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total.

In this outcome measure AST is presented.

Time Frame baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)
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FAS
Arm/Group Title Relapse Non-relapse
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FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
Overall Number of Participants Analyzed 43 75
Mean (Standard Deviation)
Unit of Measure: U/L
Baseline (N=43, 75) 54  (41) 68  (42)
week 4 (N=43, 73) 48  (71) 46  (33)
week 12 (N=43, 67) 41  (37) 48  (45)
min value on treatment (N=43, 75) 30  (16) 35  (25)
max value on treatment (N=43, 75) 63  (89) 62  (50)
last value on treatment (N=43, 75) 40  (23) 49  (39)
16.Secondary Outcome
Title Changes From Baseline in Laboratory Test Values Over Time [Bilirubin Total]
Hide Description

This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total.

In this outcome measure Bilirubin total is presented.

Time Frame baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)
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FAS
Arm/Group Title Relapse Non-relapse
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FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
Overall Number of Participants Analyzed 43 75
Mean (Standard Deviation)
Unit of Measure: milligram (mg)/dL
Baseline (N=43, 75) 0.5  (0.2) 0.5  (0.2)
week 4 (N=43, 74) 2.8  (1.6) 2.6  (1.7)
week 12 (N=43, 67) 2.7  (1.8) 2.7  (1.9)
min value on treatment (N=43, 75) 1.9  (1.3) 1.9  (1.5)
max value on treatment (N=43, 75) 3.6  (2.1) 3.5  (2.2)
last value on treatment (N=43, 75) 2.6  (1.8) 2.6  (1.9)
Time Frame from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Relapse Non-relapse
Hide Arm/Group Description FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV. FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
All-Cause Mortality
Relapse Non-relapse
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Relapse Non-relapse
Affected / at Risk (%) Affected / at Risk (%)
Total   1/43 (2.33%)   6/75 (8.00%) 
Gastrointestinal disorders     
Ascites  1  0/43 (0.00%)  1/75 (1.33%) 
Diarrhoea  1  0/43 (0.00%)  1/75 (1.33%) 
Mallory-Weiss syndrome  1  1/43 (2.33%)  0/75 (0.00%) 
Hepatobiliary disorders     
Hepatic failure  1  1/43 (2.33%)  0/75 (0.00%) 
Infections and infestations     
Gastroenteritis  1  0/43 (0.00%)  1/75 (1.33%) 
Oral fungal infection  1  0/43 (0.00%)  1/75 (1.33%) 
Pneumonia  1  1/43 (2.33%)  0/75 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  0/43 (0.00%)  1/75 (1.33%) 
Dehydration  1  0/43 (0.00%)  1/75 (1.33%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal chest pain  1  0/43 (0.00%)  1/75 (1.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer  1  0/43 (0.00%)  1/75 (1.33%) 
Nervous system disorders     
Presyncope  1  0/43 (0.00%)  1/75 (1.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Relapse Non-relapse
Affected / at Risk (%) Affected / at Risk (%)
Total   38/43 (88.37%)   68/75 (90.67%) 
Blood and lymphatic system disorders     
Anaemia  1  9/43 (20.93%)  20/75 (26.67%) 
Neutropenia  1  2/43 (4.65%)  7/75 (9.33%) 
Thrombocytopenia  1  1/43 (2.33%)  5/75 (6.67%) 
Eye disorders     
Dry eye  1  1/43 (2.33%)  4/75 (5.33%) 
Gastrointestinal disorders     
Abdominal discomfort  1  0/43 (0.00%)  4/75 (5.33%) 
Abdominal pain  1  6/43 (13.95%)  3/75 (4.00%) 
Abdominal pain upper  1  2/43 (4.65%)  8/75 (10.67%) 
Diarrhoea  1  14/43 (32.56%)  21/75 (28.00%) 
Dry mouth  1  0/43 (0.00%)  4/75 (5.33%) 
Dyspepsia  1  2/43 (4.65%)  5/75 (6.67%) 
Nausea  1  22/43 (51.16%)  34/75 (45.33%) 
Stomatitis  1  3/43 (6.98%)  2/75 (2.67%) 
Vomiting  1  11/43 (25.58%)  15/75 (20.00%) 
General disorders     
Asthenia  1  7/43 (16.28%)  13/75 (17.33%) 
Chills  1  3/43 (6.98%)  2/75 (2.67%) 
Fatigue  1  14/43 (32.56%)  11/75 (14.67%) 
Influenza like illness  1  5/43 (11.63%)  4/75 (5.33%) 
Malaise  1  1/43 (2.33%)  6/75 (8.00%) 
Pyrexia  1  4/43 (9.30%)  8/75 (10.67%) 
Hepatobiliary disorders     
Hyperbilirubinaemia  1  12/43 (27.91%)  6/75 (8.00%) 
Jaundice  1  5/43 (11.63%)  10/75 (13.33%) 
Infections and infestations     
Urinary tract infection  1  3/43 (6.98%)  1/75 (1.33%) 
Investigations     
Haemoglobin decreased  1  3/43 (6.98%)  1/75 (1.33%) 
Weight decreased  1  3/43 (6.98%)  3/75 (4.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  3/43 (6.98%)  16/75 (21.33%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/43 (4.65%)  4/75 (5.33%) 
Back pain  1  0/43 (0.00%)  4/75 (5.33%) 
Muscle spasms  1  2/43 (4.65%)  4/75 (5.33%) 
Myalgia  1  3/43 (6.98%)  9/75 (12.00%) 
Nervous system disorders     
Dizziness  1  3/43 (6.98%)  5/75 (6.67%) 
Dysgeusia  1  2/43 (4.65%)  4/75 (5.33%) 
Headache  1  10/43 (23.26%)  15/75 (20.00%) 
Psychiatric disorders     
Depression  1  3/43 (6.98%)  4/75 (5.33%) 
Insomnia  1  5/43 (11.63%)  14/75 (18.67%) 
Irritability  1  2/43 (4.65%)  6/75 (8.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  5/43 (11.63%)  11/75 (14.67%) 
Dyspnoea  1  4/43 (9.30%)  3/75 (4.00%) 
Oropharyngeal pain  1  2/43 (4.65%)  4/75 (5.33%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  4/43 (9.30%)  6/75 (8.00%) 
Dry skin  1  4/43 (9.30%)  8/75 (10.67%) 
Eczema  1  1/43 (2.33%)  5/75 (6.67%) 
Photosensitivity reaction  1  3/43 (6.98%)  1/75 (1.33%) 
Pruritus  1  13/43 (30.23%)  23/75 (30.67%) 
Rash  1  12/43 (27.91%)  21/75 (28.00%) 
Vascular disorders     
Hypertension  1  3/43 (6.98%)  1/75 (1.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 17.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Other - 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
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01330316     History of Changes
Other Study ID Numbers: 1220.48
2011-000141-20 ( EudraCT Number: EudraCT )
First Submitted: April 5, 2011
First Posted: April 6, 2011
Results First Submitted: July 3, 2015
Results First Posted: July 31, 2015
Last Update Posted: June 30, 2016