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Trial record 39 of 382 for:    IFNA2 AND RBV AND genotype

Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants

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ClinicalTrials.gov Identifier: NCT01215643
Recruitment Status : Completed
First Posted : October 6, 2010
Results First Posted : August 30, 2016
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):
Debiopharm International SA

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hepatitis C
Chronic Pain
Interventions Drug: Alisporivir
Drug: Peginterferon alfa-2a
Drug: Ribavirin
Enrollment 340
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
Hide Arm/Group Description Alisporivir (ALV) 600 mg twice daily (BID) for 1 week, followed by ALV 1000 mg once daily (QD) during Weeks 2 to 24. ALV 600 mg BID with ribavirin (RBV) for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with peginterferon alfa-2a (PEG) during Weeks 2 to 24. PEG and RBV during Weeks 1 to 24.
Period Title: Overall Study
Started 83 84 94 39 40
Completed 74 80 82 35 29
Not Completed 9 4 12 4 11
Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV Total
Hide Arm/Group Description ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24. PEG and RBV during Weeks 1 to 24. Total of all reporting groups
Overall Number of Baseline Participants 83 84 94 39 40 340
Hide Baseline Analysis Population Description
All randomized participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 83 participants 84 participants 94 participants 39 participants 40 participants 340 participants
40.2  (11.27) 42.8  (11.77) 42.6  (11.00) 43.2  (10.56) 39.9  (11.20) 41.8  (11.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 84 participants 94 participants 39 participants 40 participants 340 participants
Female
32
  38.6%
28
  33.3%
33
  35.1%
14
  35.9%
16
  40.0%
123
  36.2%
Male
51
  61.4%
56
  66.7%
61
  64.9%
25
  64.1%
24
  60.0%
217
  63.8%
1.Primary Outcome
Title Percentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ)
Hide Description RVR4LOQ was defined as RVR [serum hepatitis C virus (HCV) ribonucleic acid (RNA) < the limit of quantification (LOQ), i.e., < 25 IU/mL], after 4 weeks of treatment.
Time Frame after 4 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), defined as all participants to whom study treatment was correctly assigned.
Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
Hide Arm/Group Description:
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
PEG and RBV during Weeks 1 to 24.
Overall Number of Participants Analyzed 81 84 93 39 40
Measure Type: Number
Unit of Measure: percentage of participants
28.4 36.9 41.9 84.6 72.5
2.Secondary Outcome
Title Percentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD)
Hide Description RVR4LOD was defined as Rapid Viral Response (RVR) [serum HCV RNA < the limit of detection (LOD), i.e., < 10 IU/mL], after 4 weeks of treatment.
Time Frame after 4 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
Hide Arm/Group Description:
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
PEG and RBV during Weeks 1 to 24.
Overall Number of Participants Analyzed 81 84 93 39 40
Measure Type: Number
Unit of Measure: percentage of participants
18.5 14.3 23.7 69.2 60.0
3.Secondary Outcome
Title Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)
Hide Description [Not Specified]
Time Frame after 4 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with genotype 2 HCV infection
Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
Hide Arm/Group Description:
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
PEG and RBV during Weeks 1 to 24.
Overall Number of Participants Analyzed 23 30 26 11 13
Measure Type: Number
Unit of Measure: percentage of participants
RVR4LOQ 21.7 23.3 46.2 81.8 76.9
RVR4LOD 13.0 10.0 26.9 63.6 53.8
4.Secondary Outcome
Title Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)
Hide Description [Not Specified]
Time Frame after 4 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with genotype 3 HCV infection
Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
Hide Arm/Group Description:
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
PEG and RBV during Weeks 1 to 24.
Overall Number of Participants Analyzed 58 54 67 28 27
Measure Type: Number
Unit of Measure: percentage of participants
RVR4LOQ 31.0 44.4 40.3 85.7 70.4
RVR4LOD 20.7 16.7 22.4 71.4 63.0
5.Secondary Outcome
Title Percentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)
Hide Description cEVR12LOQ and cEVR12LOD were defined as cEVR [serum HCV RNA < LOQ and < LOD] after 12 weeks of treatment, respectively.
Time Frame after 12 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
Hide Arm/Group Description:
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
PEG and RBV during Weeks 1 to 24.
Overall Number of Participants Analyzed 81 84 93 39 40
Measure Type: Number
Unit of Measure: percentage of participants
cEVR12LOQ 93.8 95.2 90.3 94.9 85.0
cEVR12LOD 91.4 86.9 90.3 84.6 82.5
6.Secondary Outcome
Title Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)
Hide Description [Not Specified]
Time Frame after 12 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with genotype 2 HCV infection
Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
Hide Arm/Group Description:
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
PEG and RBV during Weeks 1 to 24.
Overall Number of Participants Analyzed 23 30 26 11 13
Measure Type: Number
Unit of Measure: percentage of participants
cEVR12LOQ 100.0 96.7 80.8 100.0 84.6
cEVR12LOD 100.0 83.3 80.8 90.9 84.6
7.Secondary Outcome
Title Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)
Hide Description [Not Specified]
Time Frame after 12 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with genotype 3 HCV infection
Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
Hide Arm/Group Description:
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
PEG and RBV during Weeks 1 to 24.
Overall Number of Participants Analyzed 58 54 67 28 27
Measure Type: Number
Unit of Measure: percentage of participants
cEVR12LOQ 91.4 94.4 94.0 92.9 85.2
cEVR12LOD 87.9 88.9 94.0 82.1 81.5
8.Secondary Outcome
Title Percentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)
Hide Description ETR24LOQ and ETR24LOD were defined as ETR [serum HCV RNA < LOQ and < LOD] after 24 weeks of treatment or when prematurely discontinued.
Time Frame at end of treatment, within 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
Hide Arm/Group Description:
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
PEG and RBV during Weeks 1 to 24.
Overall Number of Participants Analyzed 81 84 93 39 40
Measure Type: Number
Unit of Measure: percentage of participants
ETR24LOQ 95.1 96.4 95.7 94.9 87.5
ETR24LOD 92.6 94.0 92.5 92.3 82.5
9.Secondary Outcome
Title Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)
Hide Description [Not Specified]
Time Frame at end of treatment, within 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with genotype 2 HCV infection
Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
Hide Arm/Group Description:
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
PEG and RBV during Weeks 1 to 24.
Overall Number of Participants Analyzed 23 30 26 11 13
Measure Type: Number
Unit of Measure: percentage of participants
ETR24LOQ 100.0 96.7 84.6 100.0 92.3
ETR24LOD 100.0 96.7 76.9 100.0 84.6
10.Secondary Outcome
Title Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)
Hide Description [Not Specified]
Time Frame at end of treatment, within 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with genotype 3 HCV infection
Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
Hide Arm/Group Description:
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
PEG and RBV during Weeks 1 to 24.
Overall Number of Participants Analyzed 58 54 67 28 27
Measure Type: Number
Unit of Measure: percentage of participants
ETR24LOQ 93.1 96.3 100.0 92.9 85.2
ETR24LOD 89.7 92.6 98.5 89.3 81.5
11.Secondary Outcome
Title Percentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)
Hide Description SVR12LOQ and SVR12LOD were defined as Sustained Viral Response (SVR) [serum HCV RNA < LOQ and < LOD] 12 weeks after treatment, respectively.
Time Frame 12 weeks after the end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
Hide Arm/Group Description:
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
PEG and RBV during Weeks 1 to 24.
Overall Number of Participants Analyzed 81 84 93 39 40
Measure Type: Number
Unit of Measure: percentage of participants
SVR12LOQ 81.5 84.5 80.6 76.9 62.5
SVR12LOD 80.2 84.5 80.6 74.4 60.0
12.Secondary Outcome
Title Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)
Hide Description [Not Specified]
Time Frame 12 weeks after the end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with genotype 2 HCV infection
Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
Hide Arm/Group Description:
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
PEG and RBV during Weeks 1 to 24.
Overall Number of Participants Analyzed 23 30 26 11 13
Measure Type: Number
Unit of Measure: percentage of participants
SVR12LOQ 78.3 76.7 76.9 72.7 61.5
SVR12LOD 78.3 76.7 76.9 72.7 53.8
13.Secondary Outcome
Title Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)
Hide Description [Not Specified]
Time Frame 12 weeks after the end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with genotype 3 HCV infection
Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
Hide Arm/Group Description:
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
PEG and RBV during Weeks 1 to 24.
Overall Number of Participants Analyzed 58 54 67 28 27
Measure Type: Number
Unit of Measure: percentage of participants
SVR12LOQ 82.8 88.9 82.1 78.6 63.0
SVR12LOD 81.0 88.9 82.1 75.0 63.0
14.Secondary Outcome
Title Percentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)
Hide Description [Not Specified]
Time Frame 24 weeks after the end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
Hide Arm/Group Description:
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
PEG and RBV during Weeks 1 to 24.
Overall Number of Participants Analyzed 81 84 93 39 40
Measure Type: Number
Unit of Measure: percentage of participants
SVR24LOQ 80.2 84.5 80.6 79.5 57.5
SVR24LOD 80.2 84.5 79.6 79.5 57.5
15.Secondary Outcome
Title Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)
Hide Description [Not Specified]
Time Frame 24 weeks after the end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with genotype 2 HCV infection
Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
Hide Arm/Group Description:
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
PEG and RBV during Weeks 1 to 24.
Overall Number of Participants Analyzed 23 30 26 11 13
Measure Type: Number
Unit of Measure: percentage of participants
SVR24LOQ 78.3 76.7 76.9 72.7 53.8
SVR24LOD 78.3 76.7 76.9 72.7 53.8
16.Secondary Outcome
Title Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)
Hide Description [Not Specified]
Time Frame 24 weeks after the end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with genotype 3 HCV infection
Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
Hide Arm/Group Description:
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
PEG and RBV during Weeks 1 to 24.
Overall Number of Participants Analyzed 58 54 67 28 27
Measure Type: Number
Unit of Measure: percentage of participants
SVR24LOQ 81.0 88.9 82.1 82.1 59.3
SVR24LOD 81.0 88.9 80.6 82.1 59.3
17.Secondary Outcome
Title Percentage of Participants With On-treatment Viral Breakthrough
Hide Description

Viral breakthrough was defined as either:

  • Confirmed increase of HCV RNA ≥1 log10 above nadir (nadir = lowest HCV RNA value during treatment), or
  • HCV RNA becoming ≥ 100 IU/mL after previously being undetectable (< LOD) during treatment
Time Frame within 24 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
Hide Arm/Group Description:
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
PEG and RBV during Weeks 1 to 24.
Overall Number of Participants Analyzed 81 84 93 39 40
Measure Type: Number
Unit of Measure: percentage of participants
2.5 3.6 2.2 5.1 0.0
18.Secondary Outcome
Title Percentage of Participants With Viral Relapse
Hide Description Viral relapse was defined as having reappearance of detectable HCV RNA after previously being undetectable (< LOD) during treatment.
Time Frame within 24 weeks after the end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
Hide Arm/Group Description:
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
PEG and RBV during Weeks 1 to 24.
Overall Number of Participants Analyzed 81 84 93 39 40
Measure Type: Number
Unit of Measure: percentage of participants
0 to 12 weeks after the end of treatment 9.9 8.3 6.5 10.3 20.0
12 to 24 weeks after the end of treatment 1.2 0.0 0.0 0.0 5.0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ALV 1000 mg: On-treatment AEs ALV 600 mg+RBV: On-treatment AEs ALV 800 mg+RBV: On-treatment AEs ALV 600 mg+PEG: On-treatment AEs PEG+RBV: On-treatment AEs ALV 1000 mg: Post-treatment AEs ALV 600 mg+RBV: Post-treatment AEs ALV 800 mg+RBV: Post-treatment AEs ALV 600 mg+PEG: Post-treatment AEs PEG+RBV: Post-treatment AEs
Hide Arm/Group Description Adverse events (AEs) occurring while on treatment in participants receiving ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24. AEs occurring while on treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24. AEs occurring while on treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24. AEs occurring while on treatment in participants receiving ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24. AEs occurring while on treatment in participants receiving PEG and RBV during Weeks 1 to 24. AEs occurring after end of treatment in participants receiving ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24. AEs occurring after end of treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24. AEs occurring after end of treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24. AEs occurring after end of treatment in participants receiving ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24. AEs occurring after end of treatment in participants receiving PEG and RBV during Weeks 1 to 24.
All-Cause Mortality
ALV 1000 mg: On-treatment AEs ALV 600 mg+RBV: On-treatment AEs ALV 800 mg+RBV: On-treatment AEs ALV 600 mg+PEG: On-treatment AEs PEG+RBV: On-treatment AEs ALV 1000 mg: Post-treatment AEs ALV 600 mg+RBV: Post-treatment AEs ALV 800 mg+RBV: Post-treatment AEs ALV 600 mg+PEG: Post-treatment AEs PEG+RBV: Post-treatment AEs
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ALV 1000 mg: On-treatment AEs ALV 600 mg+RBV: On-treatment AEs ALV 800 mg+RBV: On-treatment AEs ALV 600 mg+PEG: On-treatment AEs PEG+RBV: On-treatment AEs ALV 1000 mg: Post-treatment AEs ALV 600 mg+RBV: Post-treatment AEs ALV 800 mg+RBV: Post-treatment AEs ALV 600 mg+PEG: Post-treatment AEs PEG+RBV: Post-treatment AEs
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/82 (4.88%)   1/84 (1.19%)   9/94 (9.57%)   4/39 (10.26%)   2/37 (5.41%)   2/82 (2.44%)   4/84 (4.76%)   1/94 (1.06%)   0/39 (0.00%)   0/37 (0.00%) 
Cardiac disorders                     
Acute myocardial infarction  1  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  1/94 (1.06%)  0/39 (0.00%)  0/37 (0.00%) 
Myocardial infarction  1  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%)  0/82 (0.00%)  1/84 (1.19%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Tachycardia  1  0/82 (0.00%)  0/84 (0.00%)  1/94 (1.06%)  0/39 (0.00%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Endocrine disorders                     
Hyperthyroidism  1  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%)  1/82 (1.22%)  1/84 (1.19%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Eye disorders                     
Retinopathy  1  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  1/39 (2.56%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Gastrointestinal disorders                     
Abdominal pain  1  1/82 (1.22%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Abdominal pain upper  1  1/82 (1.22%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Diarrhoea  1  1/82 (1.22%)  0/84 (0.00%)  1/94 (1.06%)  0/39 (0.00%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Inguinal hernia  1  1/82 (1.22%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Vomiting  1  0/82 (0.00%)  0/84 (0.00%)  1/94 (1.06%)  0/39 (0.00%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Infections and infestations                     
Cellulitis  1  0/82 (0.00%)  0/84 (0.00%)  1/94 (1.06%)  0/39 (0.00%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Muscle abscess  1  1/82 (1.22%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Pneumonia  1  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  1/39 (2.56%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Pyelonephritis  1  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  1/37 (2.70%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Tubo-ovarian abscess  1  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%)  1/82 (1.22%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Urinary tract infection  1  0/82 (0.00%)  0/84 (0.00%)  1/94 (1.06%)  0/39 (0.00%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Injury, poisoning and procedural complications                     
Alcohol poisoning  1  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  1/39 (2.56%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Head injury  1  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  1/39 (2.56%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Maternal exposure during pregnancy  1  0/82 (0.00%)  0/84 (0.00%)  1/94 (1.06%)  0/39 (0.00%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Toxicity to various agents  1  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  1/37 (2.70%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Metabolism and nutrition disorders                     
Dehydration  1  0/82 (0.00%)  0/84 (0.00%)  1/94 (1.06%)  0/39 (0.00%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Hypercalcaemia  1  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%)  1/82 (1.22%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Musculoskeletal and connective tissue disorders                     
Muscle spasms  1  0/82 (0.00%)  1/84 (1.19%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                     
Hepatic neoplasm malignant  1  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%)  0/82 (0.00%)  1/84 (1.19%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Psychiatric disorders                     
Anxiety  1  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%)  0/82 (0.00%)  1/84 (1.19%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Homicidal ideation  1  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  1/39 (2.56%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Major depression  1  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  1/39 (2.56%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Panic attack  1  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%)  0/82 (0.00%)  1/84 (1.19%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Suicidal ideation  1  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  1/39 (2.56%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Renal and urinary disorders                     
Calculus ureteric  1  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%)  0/82 (0.00%)  1/84 (1.19%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Renal colic  1  0/82 (0.00%)  0/84 (0.00%)  1/94 (1.06%)  0/39 (0.00%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Respiratory, thoracic and mediastinal disorders                     
Chronic obstructive pulmonary disease  1  0/82 (0.00%)  0/84 (0.00%)  1/94 (1.06%)  0/39 (0.00%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Hyperventilation  1  0/82 (0.00%)  0/84 (0.00%)  1/94 (1.06%)  0/39 (0.00%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Hypoxia  1  0/82 (0.00%)  0/84 (0.00%)  1/94 (1.06%)  0/39 (0.00%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Skin and subcutaneous tissue disorders                     
Erythema nodosum  1  0/82 (0.00%)  0/84 (0.00%)  1/94 (1.06%)  0/39 (0.00%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Vascular disorders                     
Hypertension  1  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  1/39 (2.56%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ALV 1000 mg: On-treatment AEs ALV 600 mg+RBV: On-treatment AEs ALV 800 mg+RBV: On-treatment AEs ALV 600 mg+PEG: On-treatment AEs PEG+RBV: On-treatment AEs ALV 1000 mg: Post-treatment AEs ALV 600 mg+RBV: Post-treatment AEs ALV 800 mg+RBV: Post-treatment AEs ALV 600 mg+PEG: Post-treatment AEs PEG+RBV: Post-treatment AEs
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   64/82 (78.05%)   69/84 (82.14%)   76/94 (80.85%)   37/39 (94.87%)   30/37 (81.08%)   10/82 (12.20%)   10/84 (11.90%)   13/94 (13.83%)   5/39 (12.82%)   2/37 (5.41%) 
Blood and lymphatic system disorders                     
Anaemia  1  8/82 (9.76%)  11/84 (13.10%)  10/94 (10.64%)  4/39 (10.26%)  3/37 (8.11%)  0/82 (0.00%)  0/84 (0.00%)  1/94 (1.06%)  0/39 (0.00%)  0/37 (0.00%) 
Leukopenia  1  3/82 (3.66%)  2/84 (2.38%)  2/94 (2.13%)  2/39 (5.13%)  3/37 (8.11%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Neutropenia  1  9/82 (10.98%)  8/84 (9.52%)  13/94 (13.83%)  10/39 (25.64%)  4/37 (10.81%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Thrombocytopenia  1  0/82 (0.00%)  5/84 (5.95%)  3/94 (3.19%)  6/39 (15.38%)  2/37 (5.41%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Cardiac disorders                     
Palpitations  1  0/82 (0.00%)  2/84 (2.38%)  6/94 (6.38%)  1/39 (2.56%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  1/94 (1.06%)  0/39 (0.00%)  0/37 (0.00%) 
Tachycardia  1  2/82 (2.44%)  2/84 (2.38%)  4/94 (4.26%)  2/39 (5.13%)  2/37 (5.41%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Ear and labyrinth disorders                     
Motion sickness  1  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  2/37 (5.41%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Vertigo  1  1/82 (1.22%)  1/84 (1.19%)  1/94 (1.06%)  0/39 (0.00%)  2/37 (5.41%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  1/39 (2.56%)  0/37 (0.00%) 
Endocrine disorders                     
Hyperthyroidism  1  1/82 (1.22%)  2/84 (2.38%)  1/94 (1.06%)  2/39 (5.13%)  0/37 (0.00%)  1/82 (1.22%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Hypothyroidism  1  2/82 (2.44%)  1/84 (1.19%)  3/94 (3.19%)  4/39 (10.26%)  0/37 (0.00%)  1/82 (1.22%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Eye disorders                     
Abnormal sensation in eye  1  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  2/39 (5.13%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Gastrointestinal disorders                     
Abdominal distension  1  3/82 (3.66%)  5/84 (5.95%)  6/94 (6.38%)  3/39 (7.69%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Abdominal pain  1  6/82 (7.32%)  4/84 (4.76%)  7/94 (7.45%)  2/39 (5.13%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Abdominal pain upper  1  6/82 (7.32%)  6/84 (7.14%)  7/94 (7.45%)  2/39 (5.13%)  1/37 (2.70%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Constipation  1  5/82 (6.10%)  5/84 (5.95%)  8/94 (8.51%)  3/39 (7.69%)  0/37 (0.00%)  2/82 (2.44%)  1/84 (1.19%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Diarrhoea  1  13/82 (15.85%)  6/84 (7.14%)  10/94 (10.64%)  9/39 (23.08%)  1/37 (2.70%)  1/82 (1.22%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Dry mouth  1  3/82 (3.66%)  2/84 (2.38%)  3/94 (3.19%)  2/39 (5.13%)  1/37 (2.70%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Dyspepsia  1  7/82 (8.54%)  8/84 (9.52%)  7/94 (7.45%)  0/39 (0.00%)  1/37 (2.70%)  1/82 (1.22%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Gastritis  1  0/82 (0.00%)  2/84 (2.38%)  0/94 (0.00%)  2/39 (5.13%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Mouth ulceration  1  5/82 (6.10%)  0/84 (0.00%)  3/94 (3.19%)  4/39 (10.26%)  2/37 (5.41%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Nausea  1  17/82 (20.73%)  15/84 (17.86%)  23/94 (24.47%)  9/39 (23.08%)  5/37 (13.51%)  0/82 (0.00%)  1/84 (1.19%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Vomiting  1  7/82 (8.54%)  7/84 (8.33%)  7/94 (7.45%)  2/39 (5.13%)  2/37 (5.41%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
General disorders                     
Asthenia  1  10/82 (12.20%)  7/84 (8.33%)  11/94 (11.70%)  3/39 (7.69%)  8/37 (21.62%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Chills  1  5/82 (6.10%)  3/84 (3.57%)  5/94 (5.32%)  4/39 (10.26%)  1/37 (2.70%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Fatigue  1  21/82 (25.61%)  23/84 (27.38%)  30/94 (31.91%)  18/39 (46.15%)  10/37 (27.03%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Feeling cold  1  0/82 (0.00%)  0/84 (0.00%)  2/94 (2.13%)  0/39 (0.00%)  2/37 (5.41%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Influenza like illness  1  8/82 (9.76%)  6/84 (7.14%)  9/94 (9.57%)  8/39 (20.51%)  4/37 (10.81%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Injection site erythema  1  2/82 (2.44%)  0/84 (0.00%)  0/94 (0.00%)  2/39 (5.13%)  2/37 (5.41%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Irritability  1  2/82 (2.44%)  5/84 (5.95%)  8/94 (8.51%)  2/39 (5.13%)  2/37 (5.41%)  0/82 (0.00%)  1/84 (1.19%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Malaise  1  2/82 (2.44%)  3/84 (3.57%)  0/94 (0.00%)  2/39 (5.13%)  2/37 (5.41%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Pain  1  3/82 (3.66%)  3/84 (3.57%)  5/94 (5.32%)  2/39 (5.13%)  1/37 (2.70%)  1/82 (1.22%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Pyrexia  1  14/82 (17.07%)  16/84 (19.05%)  15/94 (15.96%)  12/39 (30.77%)  9/37 (24.32%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Hepatobiliary disorders                     
Hyperbilirubinaemia  1  3/82 (3.66%)  2/84 (2.38%)  5/94 (5.32%)  0/39 (0.00%)  2/37 (5.41%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Immune system disorders                     
Hypersensitivity  1  0/82 (0.00%)  0/84 (0.00%)  2/94 (2.13%)  1/39 (2.56%)  2/37 (5.41%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Infections and infestations                     
Nasopharyngitis  1  5/82 (6.10%)  4/84 (4.76%)  5/94 (5.32%)  0/39 (0.00%)  0/37 (0.00%)  0/82 (0.00%)  1/84 (1.19%)  1/94 (1.06%)  1/39 (2.56%)  0/37 (0.00%) 
Upper respiratory tract infection  1  2/82 (2.44%)  3/84 (3.57%)  4/94 (4.26%)  4/39 (10.26%)  3/37 (8.11%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  1/39 (2.56%)  0/37 (0.00%) 
Urinary tract infection  1  5/82 (6.10%)  1/84 (1.19%)  1/94 (1.06%)  0/39 (0.00%)  2/37 (5.41%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Injury, poisoning and procedural complications                     
Wound  1  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  2/39 (5.13%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Investigations                     
Gamma-glutamyltransferase increased  1  1/82 (1.22%)  1/84 (1.19%)  1/94 (1.06%)  2/39 (5.13%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Neutrophil count decreased  1  0/82 (0.00%)  0/84 (0.00%)  1/94 (1.06%)  2/39 (5.13%)  3/37 (8.11%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Platelet count decreased  1  1/82 (1.22%)  3/84 (3.57%)  2/94 (2.13%)  2/39 (5.13%)  1/37 (2.70%)  0/82 (0.00%)  0/84 (0.00%)  1/94 (1.06%)  0/39 (0.00%)  0/37 (0.00%) 
Weight decreased  1  4/82 (4.88%)  2/84 (2.38%)  4/94 (4.26%)  3/39 (7.69%)  4/37 (10.81%)  0/82 (0.00%)  1/84 (1.19%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Metabolism and nutrition disorders                     
Decreased appetite  1  15/82 (18.29%)  14/84 (16.67%)  14/94 (14.89%)  10/39 (25.64%)  9/37 (24.32%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Musculoskeletal and connective tissue disorders                     
Arthralgia  1  9/82 (10.98%)  2/84 (2.38%)  15/94 (15.96%)  10/39 (25.64%)  5/37 (13.51%)  2/82 (2.44%)  3/84 (3.57%)  2/94 (2.13%)  0/39 (0.00%)  0/37 (0.00%) 
Back pain  1  5/82 (6.10%)  4/84 (4.76%)  10/94 (10.64%)  4/39 (10.26%)  0/37 (0.00%)  1/82 (1.22%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Muscle spasms  1  4/82 (4.88%)  3/84 (3.57%)  3/94 (3.19%)  2/39 (5.13%)  1/37 (2.70%)  1/82 (1.22%)  0/84 (0.00%)  1/94 (1.06%)  0/39 (0.00%)  0/37 (0.00%) 
Musculoskeletal pain  1  5/82 (6.10%)  3/84 (3.57%)  0/94 (0.00%)  0/39 (0.00%)  1/37 (2.70%)  0/82 (0.00%)  0/84 (0.00%)  1/94 (1.06%)  0/39 (0.00%)  0/37 (0.00%) 
Myalgia  1  10/82 (12.20%)  7/84 (8.33%)  13/94 (13.83%)  8/39 (20.51%)  8/37 (21.62%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  1/37 (2.70%) 
Nervous system disorders                     
Disturbance in attention  1  3/82 (3.66%)  1/84 (1.19%)  4/94 (4.26%)  2/39 (5.13%)  1/37 (2.70%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Dizziness  1  6/82 (7.32%)  11/84 (13.10%)  16/94 (17.02%)  5/39 (12.82%)  4/37 (10.81%)  1/82 (1.22%)  0/84 (0.00%)  1/94 (1.06%)  1/39 (2.56%)  0/37 (0.00%) 
Dysgeusia  1  4/82 (4.88%)  3/84 (3.57%)  3/94 (3.19%)  2/39 (5.13%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Headache  1  19/82 (23.17%)  18/84 (21.43%)  27/94 (28.72%)  16/39 (41.03%)  7/37 (18.92%)  0/82 (0.00%)  1/84 (1.19%)  0/94 (0.00%)  0/39 (0.00%)  1/37 (2.70%) 
Hypoaesthesia  1  0/82 (0.00%)  2/84 (2.38%)  1/94 (1.06%)  2/39 (5.13%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Memory impairment  1  1/82 (1.22%)  1/84 (1.19%)  2/94 (2.13%)  2/39 (5.13%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Paraesthesia  1  1/82 (1.22%)  1/84 (1.19%)  3/94 (3.19%)  2/39 (5.13%)  1/37 (2.70%)  0/82 (0.00%)  1/84 (1.19%)  1/94 (1.06%)  0/39 (0.00%)  0/37 (0.00%) 
Somnolence  1  2/82 (2.44%)  1/84 (1.19%)  1/94 (1.06%)  4/39 (10.26%)  1/37 (2.70%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Syncope  1  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  3/39 (7.69%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  1/39 (2.56%)  0/37 (0.00%) 
Psychiatric disorders                     
Anxiety  1  8/82 (9.76%)  9/84 (10.71%)  5/94 (5.32%)  1/39 (2.56%)  5/37 (13.51%)  1/82 (1.22%)  0/84 (0.00%)  1/94 (1.06%)  0/39 (0.00%)  0/37 (0.00%) 
Depressed mood  1  2/82 (2.44%)  2/84 (2.38%)  3/94 (3.19%)  2/39 (5.13%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Depression  1  12/82 (14.63%)  7/84 (8.33%)  9/94 (9.57%)  3/39 (7.69%)  3/37 (8.11%)  0/82 (0.00%)  0/84 (0.00%)  4/94 (4.26%)  0/39 (0.00%)  0/37 (0.00%) 
Insomnia  1  11/82 (13.41%)  12/84 (14.29%)  14/94 (14.89%)  4/39 (10.26%)  6/37 (16.22%)  0/82 (0.00%)  2/84 (2.38%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Sleep disorder  1  2/82 (2.44%)  4/84 (4.76%)  3/94 (3.19%)  2/39 (5.13%)  1/37 (2.70%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Respiratory, thoracic and mediastinal disorders                     
Cough  1  11/82 (13.41%)  13/84 (15.48%)  12/94 (12.77%)  3/39 (7.69%)  4/37 (10.81%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Dyspnoea  1  3/82 (3.66%)  6/84 (7.14%)  3/94 (3.19%)  2/39 (5.13%)  2/37 (5.41%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Dyspnoea exertional  1  1/82 (1.22%)  6/84 (7.14%)  4/94 (4.26%)  1/39 (2.56%)  3/37 (8.11%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Oropharyngeal Pain  1  5/82 (6.10%)  2/84 (2.38%)  5/94 (5.32%)  2/39 (5.13%)  1/37 (2.70%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Productive cough  1  0/82 (0.00%)  1/84 (1.19%)  1/94 (1.06%)  2/39 (5.13%)  1/37 (2.70%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Skin and subcutaneous tissue disorders                     
Alopecia  1  10/82 (12.20%)  8/84 (9.52%)  4/94 (4.26%)  9/39 (23.08%)  7/37 (18.92%)  0/82 (0.00%)  1/84 (1.19%)  1/94 (1.06%)  0/39 (0.00%)  0/37 (0.00%) 
Dry skin  1  8/82 (9.76%)  5/84 (5.95%)  6/94 (6.38%)  3/39 (7.69%)  3/37 (8.11%)  1/82 (1.22%)  1/84 (1.19%)  1/94 (1.06%)  0/39 (0.00%)  0/37 (0.00%) 
Eczema  1  2/82 (2.44%)  0/84 (0.00%)  2/94 (2.13%)  0/39 (0.00%)  3/37 (8.11%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Erythema  1  0/82 (0.00%)  1/84 (1.19%)  2/94 (2.13%)  2/39 (5.13%)  0/37 (0.00%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  0/39 (0.00%)  0/37 (0.00%) 
Pruritus  1  14/82 (17.07%)  14/84 (16.67%)  12/94 (12.77%)  7/39 (17.95%)  6/37 (16.22%)  1/82 (1.22%)  0/84 (0.00%)  0/94 (0.00%)  1/39 (2.56%)  0/37 (0.00%) 
Rash  1  11/82 (13.41%)  9/84 (10.71%)  14/94 (14.89%)  2/39 (5.13%)  3/37 (8.11%)  0/82 (0.00%)  0/84 (0.00%)  0/94 (0.00%)  1/39 (2.56%)  0/37 (0.00%) 
Vascular disorders                     
Hypertension  1  9/82 (10.98%)  10/84 (11.90%)  8/94 (8.51%)  5/39 (12.82%)  1/37 (2.70%)  0/82 (0.00%)  0/84 (0.00%)  1/94 (1.06%)  0/39 (0.00%)  0/37 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.0)
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.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vice President Clinical Research & Development
Organization: Debiopharm International S.A.
Phone: 4121 321 01 11
EMail: info-international@debiopharm.com
Layout table for additonal information
Responsible Party: Debiopharm International SA
ClinicalTrials.gov Identifier: NCT01215643     History of Changes
Other Study ID Numbers: CDEB025A2211
2010-020034-26 ( EudraCT Number )
First Submitted: October 5, 2010
First Posted: October 6, 2010
Results First Submitted: July 20, 2016
Results First Posted: August 30, 2016
Last Update Posted: August 30, 2016