Efficacy and Safety of Adding Alisporivir (DEB025) to Peg... | NCT01183169 | Trialant
NCT01183169
Sponsor
Debiopharm International SA
Status
Completed
Last Update Posted
Aug 25, 2016Estimated
Enrollment
459Actual
Phase
Phase 2
Conditions
Hepatitis C
Interventions
Alisporivir
Peginterferon alfa-2a
Ribavirin
Placebo
Countries
United States
Australia
Belgium
France
Germany
Hungary
Italy
Poland
Puerto Rico
Romania
Spain
Taiwan
Turkey (Türkiye)
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01183169
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CDEB025A2210
Secondary IDs
ID
Type
Description
Link
2010-020033-14
EudraCT Number
Brief Title
Efficacy and Safety of Adding Alisporivir (DEB025) to Peginterferon (IFN) Alfa-2a (Peg-IFN Alfa-2a) and Ribavirin in Chronic HCV Genotype 1 Patients Who Relapsed or Did Not Respond to Previous Treatment
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Study on Efficacy and Safety of DEB025 Combined With Peg-IFN Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Relapsers and Non-responders to Previous Peg-IFN Alfa-2 Plus Ribavirin Treatment
Acronym
Not provided
Organization
Debiopharm International SAINDUSTRY
Status Module
Record Verification Date
Jul 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 2010
Primary Completion Date
May 2013Actual
Completion Date
May 2013Actual
First Submitted Date
Aug 16, 2010
First Submission Date that Met QC Criteria
Aug 16, 2010
First Posted Date
Aug 17, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 14, 2016
Results First Submitted that Met QC Criteria
Jul 14, 2016
Results First Posted Date
Aug 25, 2016Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 14, 2016
Last Update Posted Date
Aug 25, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Debiopharm International SAINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The study is to investigate whether participants with hepatitis C virus (HCV) genotype 1 who have a history of non-response/relapse to peginterferon alfa-2a (PEG) and ribavirin (RBV) may benefit from treatment with triple therapy alisporivir (ALV; DEB025) with PEG and RBV versus placebo with PEG and RBV.
Detailed Description
Not provided
Conditions Module
Conditions
Hepatitis C
Keywords
Chronic hepatitis C
Cyclophilin inhibitor
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
459Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Treatment A: ALV 600 mg QD
Experimental
Alisporivir (ALV) 600 mg once daily (QD) with Peginterferon alfa-2a (PEG) and Ribavirin (RBV) for up to 48 weeks
Drug: Alisporivir
Drug: Peginterferon alfa-2a
Drug: Ribavirin
Treatment B: ALV 800 mg QD
Experimental
Alisporivir (ALV) 800 mg QD with PEG and RBV for up to 48 weeks
Drug: Alisporivir
Drug: Peginterferon alfa-2a
Drug: Ribavirin
Treatment C1: ALV Placebo - 600 mg QD
Experimental
ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving complete early virologic response (cEVR) after 12 weeks of treatment may switch to active ALV 600 mg QD with PEG and RBV.
Drug: Alisporivir
Drug: Peginterferon alfa-2a
Drug: Ribavirin
Drug: Placebo
Treatment C2: ALV Placebo - 400 mg BID
Experimental
ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR after 12 weeks of treatment may switch to active ALV 400 mg twice daily (BID) with PEG and RBV.
Drug: Alisporivir
Drug: Peginterferon alfa-2a
Drug: Ribavirin
Drug: Placebo
Treatment D: ALV 400 mg BID
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Alisporivir
Drug
ALV 200 mg soft gel capsules administered orally
Treatment A: ALV 600 mg QD
Treatment B: ALV 800 mg QD
Treatment C1: ALV Placebo - 600 mg QD
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ)
cEVR-LOQ was defined as serum HCV RNA below the limit of quantification (< LOQ; i.e., 25 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.
after 12 weeks of treatment
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD)
cEVR-LOD was defined as serum HCV RNA below the limit of detection (< LOD; i.e., 10 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.
after 12 weeks of treatment
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Chronic HCV genotype 1 viral infection
HCV RNA ≥ 1,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening
Previous non-responders/relapsers to PEG and RBV after treatment for at least 12 weeks
Exclusion criteria:
Treatment with any anti-HCV drug (whether approved or investigational) within 3 months prior to screening
Women of child-bearing potential unless using highly effective
Any other cause of relevant liver disease other than HCV
Other protocol-defined inclusion/exclusion criteria may apply
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
70 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Novartis Investigative Site
San Diego
California
92101
United States
Novartis Investigative Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Treatment A
Alisporivir (ALV; DEB025) 600 mg once daily (QD) with peginterferon alfa-2a (PEG) and ribavirin (RBV) for up to 48 weeks.
FG001
Treatment B
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
Periods
Title
Milestones
Reasons Not Completed
Main Phase
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Experimental
Alisporivir (ALV) 400 mg twice daily BID with PEG and RBV for up to 48 weeks
Drug: Alisporivir
Drug: Peginterferon alfa-2a
Drug: Ribavirin
Treatment C2: ALV Placebo - 400 mg BID
Treatment D: ALV 400 mg BID
DEB025
ALV
Peginterferon alfa-2a
Drug
PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
Treatment A: ALV 600 mg QD
Treatment B: ALV 800 mg QD
Treatment C1: ALV Placebo - 600 mg QD
Treatment C2: ALV Placebo - 400 mg BID
Treatment D: ALV 400 mg BID
Pegasys®
PEG
Ribavirin
Drug
RBV 200 mg tablets (weight-based dose: < 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose
Treatment A: ALV 600 mg QD
Treatment B: ALV 800 mg QD
Treatment C1: ALV Placebo - 600 mg QD
Treatment C2: ALV Placebo - 400 mg BID
Treatment D: ALV 400 mg BID
Copegus®
RBV
Placebo
Drug
ALV placebo soft gel capsules administered orally
Treatment C1: ALV Placebo - 600 mg QD
Treatment C2: ALV Placebo - 400 mg BID
ALV Placebo
Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD
SVR12-LOQ and SVR12-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD 12 weeks after treatment, respectively.
12 weeks after treatment
Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD
SVR24-LOQ and SVR24-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD 24 weeks after treatment, respectively.
24 weeks after treatment
Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD
RVR-LOQ and RVR-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD after 4 weeks of treatment, respectively. Post-switch groups were assessed 4 weeks after the switch.
after 4 weeks of treatment
Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD
pEVR-LOQ and pEVR-LOD were defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ and ≥ LOD, respectively) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.
after 12 weeks of treatment
Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD
ETR-LOQ and ETR-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD at treatment end (completed or prematurely discontinued), respectively.
within 48 weeks
Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End
Up to 48 weeks
Percentage of Participants With On-treatment Viral Breakthrough
On-treatment 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 (< LOQ) during treatment
within 48 weeks
Percentage of Participants With Viral Relapse
Viral relapse was defined as reappearance of detectable HCV RNA after previously being undetectable (< LOQ) during treatment.
Treatment C subset C1: ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving complete early virologic response (cEVR: hepatitis C virus (HCV) ribonucleic acid (RNA) \
FG003
Treatment C2
Treatment C subset C2: ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV 400 mg twice daily (BID) with PEG and RBV.
FG004
Treatment D
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
FG005
Treatment C1A
ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
FG006
Treatment C2A
ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
FG000121 subjects
FG001115 subjects
FG00259 subjects
FG00355 subjects
FG004109 subjects
FG0050 subjects
FG0060 subjects
Completed Treatment
FG00072 subjects
FG00178 subjects
FG00217 subjects
FG00317 subjects
FG00477 subjects
FG0050 subjects
FG0060 subjects
Switched to ALV
FG0000 subjects
FG0010 subjects
FG00235 subjects
FG00330 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
FG00094 subjects
FG00193 subjects
FG00218 subjects
FG00318 subjects
FG00483 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG00027 subjects
FG00122 subjects
FG00241 subjects
FG00337 subjects
FG00426 subjects
FG0050 subjects
FG0060 subjects
Post-switch Phase
Type
Comment
Milestone Data
STARTED
FG0000 subjectsNot a post-switch group
FG0010 subjectsNot a post-switch group
FG0020 subjectsNot a post-switch group
FG0030 subjectsNot a post-switch group
FG0040 subjectsNot a post-switch group
FG00535 subjectsParticipants in Treatment C1 who switched to active ALV
FG00630 subjectsParticipants in Treatment C2 who switched to active ALV
Completed Treatment
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
All randomized participants
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Treatment A
ALV 600 mg QD with PEG and RBV for up to 48 weeks.
BG001
Treatment B
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
BG002
Treatment C
Treatment C1 + Treatment C2. ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
BG003
Treatment D
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000121
BG001115
BG002114
BG003109
BG004459
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00050.2± 9.24
BG00150.9± 10.11
BG00250.5± 10.50
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00058
BG00147
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ)
cEVR-LOQ was defined as serum HCV RNA below the limit of quantification (< LOQ; i.e., 25 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.
Full Analysis Set (FAS) For Efficacy, defined as all randomized participants who were randomized after the 2nd protocol amendment
Posted
Number
percentage of participants
after 12 weeks of treatment
ID
Title
Description
OG000
Treatment A
ALV 600 mg QD with PEG and RBV for up to 48 weeks.
OG001
Treatment B
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
OG002
Treatment C
ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
OG003
Treatment D
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
OG004
Treatment C1A
ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
OG005
Treatment C2A
ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
Units
Counts
Participants
OG000110
OG001108
OG002110
OG003
Title
Denominators
Categories
Title
Measurements
OG00048.2
OG00161.1
OG00235.5
OG003
Secondary
Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD)
cEVR-LOD was defined as serum HCV RNA below the limit of detection (< LOD; i.e., 10 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.
FAS For Efficacy
Posted
Number
percentage of participants
after 12 weeks of treatment
ID
Title
Description
OG000
Treatment A
ALV 600 mg QD with PEG and RBV for up to 48 weeks.
OG001
Treatment B
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
OG002
Treatment C
ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
OG003
Treatment D
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
OG004
Treatment C1A
Secondary
Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD
SVR12-LOQ and SVR12-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD 12 weeks after treatment, respectively.
FAS For Efficacy
Posted
Number
percentage of participants
12 weeks after treatment
ID
Title
Description
OG000
Treatment A
ALV 600 mg QD with PEG and RBV for up to 48 weeks.
OG001
Treatment B
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
OG002
Treatment C
ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
OG003
Treatment D
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
OG004
Treatment C1A
Secondary
Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD
SVR24-LOQ and SVR24-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD 24 weeks after treatment, respectively.
FAS For Efficacy
Posted
Number
percentage of participants
24 weeks after treatment
ID
Title
Description
OG000
Treatment A
ALV 600 mg QD with PEG and RBV for up to 48 weeks.
OG001
Treatment B
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
OG002
Treatment C
ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
OG003
Treatment D
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
OG004
Treatment C1A
Secondary
Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD
RVR-LOQ and RVR-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD after 4 weeks of treatment, respectively. Post-switch groups were assessed 4 weeks after the switch.
FAS For Efficacy
Posted
Number
percentage of participants
after 4 weeks of treatment
ID
Title
Description
OG000
Treatment A
ALV 600 mg QD with PEG and RBV for up to 48 weeks.
OG001
Treatment B
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
OG002
Treatment C
ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
OG003
Treatment D
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
OG004
Treatment C1A
Secondary
Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD
pEVR-LOQ and pEVR-LOD were defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ and ≥ LOD, respectively) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.
FAS For Efficacy
Posted
Number
percentage of participants
after 12 weeks of treatment
ID
Title
Description
OG000
Treatment A
ALV 600 mg QD with PEG and RBV for up to 48 weeks.
OG001
Treatment B
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
OG002
Treatment C
ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
OG003
Treatment D
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
OG004
Secondary
Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD
ETR-LOQ and ETR-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD at treatment end (completed or prematurely discontinued), respectively.
FAS For Efficacy
Posted
Number
percentage of participants
within 48 weeks
ID
Title
Description
OG000
Treatment A
ALV 600 mg QD with PEG and RBV for up to 48 weeks.
OG001
Treatment B
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
OG002
Treatment C
ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
OG003
Treatment D
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
OG004
Treatment C1A
Secondary
Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End
Participants in the FAS For Efficacy with abnormal ALT at baseline and available data at the respective time point
Posted
Number
percentage of participants
Up to 48 weeks
ID
Title
Description
OG000
Treatment A
ALV 600 mg QD with PEG and RBV for up to 48 weeks.
OG001
Treatment B
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
OG002
Treatment C
ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
OG003
Treatment D
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
OG004
Treatment C1A
ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
Secondary
Percentage of Participants With On-treatment Viral Breakthrough
On-treatment 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 (< LOQ) during treatment
FAS For Efficacy
Posted
Number
percentage of participants
within 48 weeks
ID
Title
Description
OG000
Treatment A
ALV 600 mg QD with PEG and RBV for up to 48 weeks.
OG001
Treatment B
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
OG002
Treatment C
ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
OG003
Treatment D
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
OG004
Treatment C1A
Secondary
Percentage of Participants With Viral Relapse
Viral relapse was defined as reappearance of detectable HCV RNA after previously being undetectable (< LOQ) during treatment.
FAS For Efficacy
Posted
Number
percentage of participants
within 24 weeks after treatment
ID
Title
Description
OG000
Treatment A
ALV 600 mg QD with PEG and RBV for up to 48 weeks.
OG001
Treatment B
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
OG002
Treatment C
ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
OG003
Treatment D
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
OG004
Treatment C1A
ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Treatment A: On-treatment AEs
Adverse events (AEs) occurring while on treatment in participants receiving ALV 600 mg QD with PEG and RBV for up to 48 weeks.
7
120
116
120
EG001
Treatment B: On-treatment AEs
AEs occurring while on treatment in participants receiving ALV 800 mg QD with PEG and RBV for up to 48 weeks.
11
115
108
115
EG002
Treatment C1: On-treatment AEs
AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 600 mg QD post-switch) with PEG and RBV for up to 48 weeks.
5
59
58
59
EG003
Treatment C2: On-treatment AEs
AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 400 mg BID post-switch) with PEG and RBV for up to 48 weeks.
1
55
54
55
EG004
Treatment D: On-treatment AEs
AEs occurring while on treatment in participants receiving ALV 400 mg BID with PEG and RBV for up to 48 weeks.
18
108
106
108
EG005
Treatment A: Post-treatment AEs
AEs occurring after end of treatment in participants receiving ALV 600 mg QD with PEG and RBV for up to 48 weeks.
2
120
22
120
EG006
Treatment B: Post-treatment AEs
AEs occurring after end of treatment in participants receiving ALV 800 mg QD with PEG and RBV for up to 48 weeks.
4
115
21
115
EG007
Treatment C1: Post-treatment AEs
AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 600 mg QD post-switch) with PEG and RBV for up to 48 weeks.
0
59
13
59
EG008
Treatment C2: Post-treatment AEs
AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 400 mg BID post-switch) with PEG and RBV for up to 48 weeks.
0
55
10
55
EG009
Treatment D: Post-treatment AEs
AEs occurring after end of treatment in participants receiving ALV 400 mg BID with PEG and RBV for up to 48 weeks.
0
108
19
108
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0011 affected115 at risk
EG0020 affected59 at risk
EG0030 affected55 at risk
EG0040 affected108 at risk
EG0050 affected120 at risk
EG0060 affected115 at risk
EG0070 affected59 at risk
EG0080 affected55 at risk
EG0090 affected108 at risk
Alanine aminotransferase increased
Investigations
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0012 affected115 at risk
EG0020 affected59 at risk
EG003
Appendicitis
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0012 affected115 at risk
EG0020 affected59 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0011 affected115 at risk
EG0020 affected59 at risk
EG003
Arthritis viral
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0011 affected115 at risk
EG0020 affected59 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Chest discomfort
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0011 affected115 at risk
EG0020 affected59 at risk
EG003
Chest pain
General disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected120 at risk
EG0010 affected115 at risk
EG0021 affected59 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0011 affected115 at risk
EG0020 affected59 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0011 affected115 at risk
EG0020 affected59 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Cystitis
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0011 affected115 at risk
EG0020 affected59 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0011 affected115 at risk
EG0020 affected59 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Drug interaction
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0011 affected115 at risk
EG0020 affected59 at risk
EG003
Ear infection
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0011 affected115 at risk
EG0020 affected59 at risk
EG003
Endometriosis
Reproductive system and breast disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0011 affected115 at risk
EG0020 affected59 at risk
EG003
Fatigue
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Headache
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Hepatitis C
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0001 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Hyperamylasaemia
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Hyperlipasaemia
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Hypertension
Vascular disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected120 at risk
EG0011 affected115 at risk
EG0020 affected59 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Hypopituitarism
Endocrine disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0011 affected115 at risk
EG0020 affected59 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0021 affected59 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0021 affected59 at risk
EG003
Multi-organ failure
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0011 affected115 at risk
EG0021 affected59 at risk
EG003
Non-small cell lung cancer stage I
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (16.0)
Systematic Assessment
EG0001 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Orchitis
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0001 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Peritonitis
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0011 affected115 at risk
EG0020 affected59 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0021 affected59 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0011 affected115 at risk
EG0020 affected59 at risk
EG003
Psychotic disorder
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Pulmonary mass
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Pyrexia
General disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0021 affected59 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0011 affected115 at risk
EG0020 affected59 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Salpingitis
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Septic shock
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Syncope
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0011 affected115 at risk
EG0020 affected59 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0001 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Vascular pseudoaneurysm
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0001 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Vena cava thrombosis
Vascular disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Vertebrobasilar insufficiency
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0010 affected115 at risk
EG0020 affected59 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (16.0)
Systematic Assessment
EG00049 affected120 at risk
EG00141 affected115 at risk
EG00224 affected59 at risk
EG00321 affected55 at risk
EG00451 affected108 at risk
EG0050 affected120 at risk
EG0060 affected115 at risk
EG0070 affected59 at risk
EG0081 affected55 at risk
EG0090 affected108 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA (16.0)
Systematic Assessment
EG00017 affected120 at risk
EG00113 affected115 at risk
EG0028 affected59 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA (16.0)
Systematic Assessment
EG0005 affected120 at risk
EG0012 affected115 at risk
EG0024 affected59 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (16.0)
Systematic Assessment
EG00049 affected120 at risk
EG00140 affected115 at risk
EG00222 affected59 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (16.0)
Systematic Assessment
EG00024 affected120 at risk
EG00119 affected115 at risk
EG0024 affected59 at risk
EG003
Palpitations
Cardiac disorders
MedDRA (16.0)
Systematic Assessment
EG00011 affected120 at risk
EG0017 affected115 at risk
EG0023 affected59 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (16.0)
Systematic Assessment
EG0002 affected120 at risk
EG0011 affected115 at risk
EG0022 affected59 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA (16.0)
Systematic Assessment
EG0004 affected120 at risk
EG0014 affected115 at risk
EG0023 affected59 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA (16.0)
Systematic Assessment
EG0007 affected120 at risk
EG0016 affected115 at risk
EG0022 affected59 at risk
EG003
Dry eye
Eye disorders
MedDRA (16.0)
Systematic Assessment
EG0007 affected120 at risk
EG0017 affected115 at risk
EG0023 affected59 at risk
EG003
Ocular icterus
Eye disorders
MedDRA (16.0)
Systematic Assessment
EG0005 affected120 at risk
EG0018 affected115 at risk
EG0021 affected59 at risk
EG003
Vision blurred
Eye disorders
MedDRA (16.0)
Systematic Assessment
EG0004 affected120 at risk
EG0018 affected115 at risk
EG0023 affected59 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0002 affected120 at risk
EG0015 affected115 at risk
EG0022 affected59 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0009 affected120 at risk
EG0017 affected115 at risk
EG0027 affected59 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG00015 affected120 at risk
EG0018 affected115 at risk
EG0025 affected59 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0006 affected120 at risk
EG0013 affected115 at risk
EG0023 affected59 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected120 at risk
EG0016 affected115 at risk
EG0022 affected59 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG00010 affected120 at risk
EG0017 affected115 at risk
EG0022 affected59 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG00019 affected120 at risk
EG00118 affected115 at risk
EG00211 affected59 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG00015 affected120 at risk
EG00110 affected115 at risk
EG0025 affected59 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG00015 affected120 at risk
EG0014 affected115 at risk
EG0025 affected59 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0002 affected120 at risk
EG0011 affected115 at risk
EG0022 affected59 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0007 affected120 at risk
EG00110 affected115 at risk
EG0023 affected59 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG00046 affected120 at risk
EG00135 affected115 at risk
EG00217 affected59 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0003 affected120 at risk
EG0013 affected115 at risk
EG0023 affected59 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG00019 affected120 at risk
EG00118 affected115 at risk
EG0027 affected59 at risk
EG003
Asthenia
General disorders
MedDRA (16.0)
Systematic Assessment
EG00019 affected120 at risk
EG00130 affected115 at risk
EG0029 affected59 at risk
EG003
Chest pain
General disorders
MedDRA (16.0)
Systematic Assessment
EG0003 affected120 at risk
EG0014 affected115 at risk
EG0022 affected59 at risk
EG003
Chills
General disorders
MedDRA (16.0)
Systematic Assessment
EG00014 affected120 at risk
EG00113 affected115 at risk
EG0026 affected59 at risk
EG003
Fatigue
General disorders
MedDRA (16.0)
Systematic Assessment
EG00047 affected120 at risk
EG00145 affected115 at risk
EG00225 affected59 at risk
EG003
Influenza like illness
General disorders
MedDRA (16.0)
Systematic Assessment
EG00013 affected120 at risk
EG00110 affected115 at risk
EG00215 affected59 at risk
EG003
Injection site erythema
General disorders
MedDRA (16.0)
Systematic Assessment
EG0008 affected120 at risk
EG00111 affected115 at risk
EG0025 affected59 at risk
EG003
Injection site rash
General disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected120 at risk
EG0011 affected115 at risk
EG0024 affected59 at risk
EG003
Irritability
General disorders
MedDRA (16.0)
Systematic Assessment
EG0008 affected120 at risk
EG0017 affected115 at risk
EG0023 affected59 at risk
EG003
Malaise
General disorders
MedDRA (16.0)
Systematic Assessment
EG0009 affected120 at risk
EG0018 affected115 at risk
EG0022 affected59 at risk
EG003
Pyrexia
General disorders
MedDRA (16.0)
Systematic Assessment
EG00032 affected120 at risk
EG00134 affected115 at risk
EG00218 affected59 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA (16.0)
Systematic Assessment
EG00019 affected120 at risk
EG00114 affected115 at risk
EG0024 affected59 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA (16.0)
Systematic Assessment
EG00014 affected120 at risk
EG00111 affected115 at risk
EG0025 affected59 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0006 affected120 at risk
EG0015 affected115 at risk
EG0021 affected59 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0004 affected120 at risk
EG0017 affected115 at risk
EG0022 affected59 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0004 affected120 at risk
EG0013 affected115 at risk
EG0022 affected59 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG00012 affected120 at risk
EG0015 affected115 at risk
EG0023 affected59 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0007 affected120 at risk
EG0012 affected115 at risk
EG0024 affected59 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (16.0)
Systematic Assessment
EG0006 affected120 at risk
EG0011 affected115 at risk
EG0021 affected59 at risk
EG003
Lipase increased
Investigations
MedDRA (16.0)
Systematic Assessment
EG0002 affected120 at risk
EG0011 affected115 at risk
EG0024 affected59 at risk
EG003
Total bile acids increased
Investigations
MedDRA (16.0)
Systematic Assessment
EG0005 affected120 at risk
EG0013 affected115 at risk
EG0023 affected59 at risk
EG003
Weight decreased
Investigations
MedDRA (16.0)
Systematic Assessment
EG0009 affected120 at risk
EG0019 affected115 at risk
EG0023 affected59 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG00031 affected120 at risk
EG00123 affected115 at risk
EG0029 affected59 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG00016 affected120 at risk
EG00121 affected115 at risk
EG0024 affected59 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG00019 affected120 at risk
EG00119 affected115 at risk
EG0028 affected59 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG00020 affected120 at risk
EG0015 affected115 at risk
EG0024 affected59 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG00014 affected120 at risk
EG00112 affected115 at risk
EG0023 affected59 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG00023 affected120 at risk
EG00121 affected115 at risk
EG00216 affected59 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0004 affected120 at risk
EG0011 affected115 at risk
EG0023 affected59 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0005 affected120 at risk
EG0016 affected115 at risk
EG0020 affected59 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0007 affected120 at risk
EG0015 affected115 at risk
EG0023 affected59 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0009 affected120 at risk
EG00110 affected115 at risk
EG0023 affected59 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG00020 affected120 at risk
EG00122 affected115 at risk
EG00211 affected59 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0005 affected120 at risk
EG0017 affected115 at risk
EG0024 affected59 at risk
EG003
Headache
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG00059 affected120 at risk
EG00147 affected115 at risk
EG00224 affected59 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0006 affected120 at risk
EG0012 affected115 at risk
EG0021 affected59 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0005 affected120 at risk
EG0014 affected115 at risk
EG0022 affected59 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG00019 affected120 at risk
EG0018 affected115 at risk
EG0024 affected59 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG0003 affected120 at risk
EG0014 affected115 at risk
EG0023 affected59 at risk
EG003
Depression
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG00022 affected120 at risk
EG00114 affected115 at risk
EG00210 affected59 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG00035 affected120 at risk
EG00124 affected115 at risk
EG00211 affected59 at risk
EG003
Nervousness
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected120 at risk
EG0011 affected115 at risk
EG0022 affected59 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG0007 affected120 at risk
EG0014 affected115 at risk
EG0022 affected59 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG0002 affected120 at risk
EG0014 affected115 at risk
EG0024 affected59 at risk
EG003
Suspiciousness
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected120 at risk
EG0014 affected115 at risk
EG0021 affected59 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG00038 affected120 at risk
EG00129 affected115 at risk
EG00218 affected59 at risk
EG003
Dry throat
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0011 affected115 at risk
EG0023 affected59 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG00021 affected120 at risk
EG0018 affected115 at risk
EG0026 affected59 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0006 affected120 at risk
EG0019 affected115 at risk
EG0023 affected59 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0005 affected120 at risk
EG0013 affected115 at risk
EG0024 affected59 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0009 affected120 at risk
EG0018 affected115 at risk
EG0025 affected59 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG00022 affected120 at risk
EG00123 affected115 at risk
EG00210 affected59 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected120 at risk
EG0010 affected115 at risk
EG0023 affected59 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0003 affected120 at risk
EG0012 affected115 at risk
EG0023 affected59 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG00015 affected120 at risk
EG00116 affected115 at risk
EG00211 affected59 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0006 affected120 at risk
EG0017 affected115 at risk
EG0020 affected59 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0002 affected120 at risk
EG0011 affected115 at risk
EG0025 affected59 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG00036 affected120 at risk
EG00130 affected115 at risk
EG00221 affected59 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG00023 affected120 at risk
EG00122 affected115 at risk
EG00215 affected59 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected120 at risk
EG0012 affected115 at risk
EG0020 affected59 at risk
EG003
Hypertension
Vascular disorders
MedDRA (16.0)
Systematic Assessment
EG00021 affected120 at risk
EG00122 affected115 at risk
EG0025 affected59 at risk
EG003
In April 2012, ALV and placebo were discontinued in all participants. Participants remained on PEG and RBV treatment.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Vice President Clinical Research & Development
Debiopharm International S.A.
4121 321 01 11
info-international@debiopharm.com
ID
Term
D006526
Hepatitis C
D019698
Hepatitis C, Chronic
Ancestor Terms
ID
Term
D000086982
Blood-Borne Infections
D003141
Communicable Diseases
D007239
Infections
D006525
Hepatitis, Viral, Human
D014777
Virus Diseases
D018178
Flaviviridae Infections
D012327
RNA Virus Infections
D006505
Hepatitis
D008107
Liver Diseases
D004066
Digestive System Diseases
D006521
Hepatitis, Chronic
D002908
Chronic Disease
D020969
Disease Attributes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C499715
alisporivir
C100416
peginterferon alfa-2a
D012254
Ribavirin
Ancestor Terms
ID
Term
D012263
Ribonucleosides
D009705
Nucleosides
D009706
Nucleic Acids, Nucleotides, and Nucleosides
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG00512 subjects
FG00613 subjects
0 subjects
FG00521 subjects
FG00621 subjects
0 subjects
FG00514 subjects
FG0069 subjects
51.0
± 9.68
BG00450.6± 9.86
36
BG00340
BG004181
Male
BG00063
BG00168
BG00278
BG00369
BG004278
109
OG00433
OG00530
74.3
OG00445.5
OG00580.0
ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
OG005
Treatment C2A
ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
Units
Counts
Participants
OG000110
OG001108
OG002110
OG003109
OG00433
OG00530
Title
Denominators
Categories
Title
Measurements
OG00039.1
OG00141.7
OG00220.9
OG00358.7
OG00439.4
OG00573.3
ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
OG005
Treatment C2A
ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
Units
Counts
Participants
OG000110
OG001108
OG002110
OG003109
OG00433
OG00530
Title
Denominators
Categories
SVR12-LOQ
Title
Measurements
OG00042.7
OG00151.9
OG00214.5
OG00365.1
OG00418.2
OG00553.3
SVR12-LOD
Title
Measurements
OG00040.9
OG00150.9
OG00214.5
OG003
ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
OG005
Treatment C2A
ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
Units
Counts
Participants
OG000110
OG001108
OG002110
OG003109
OG00433
OG00530
Title
Denominators
Categories
SVR24-LOQ
Title
Measurements
OG00041.8
OG00151.9
OG00214.5
OG00365.1
OG00418.2
OG00553.3
SVR24-LOD
Title
Measurements
OG00040.0
OG00150.0
OG00214.5
OG003
ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
OG005
Treatment C2A
ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
Units
Counts
Participants
OG000110
OG001108
OG002110
OG003109
OG00433
OG00530
Title
Denominators
Categories
RVR-LOQ
Title
Measurements
OG00020.9
OG00125.0
OG0027.3
OG00341.3
OG00439.4
OG00556.7
RVR-LOD
Title
Measurements
OG0009.1
OG0018.3
OG0022.7
OG003
Treatment C1A
ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
OG005
Treatment C2A
ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
Units
Counts
Participants
OG000110
OG001108
OG002110
OG003109
OG00433
OG00530
Title
Denominators
Categories
pEVR-LOQ
Title
Measurements
OG00038.2
OG00128.7
OG00231.8
OG00311.9
OG0043.0
OG0056.7
pEVR-LOD
Title
Measurements
OG00047.3
OG00148.1
OG00246.4
OG003
ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
OG005
Treatment C2A
ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
Units
Counts
Participants
OG000110
OG001108
OG002110
OG003109
OG00433
OG00530
Title
Denominators
Categories
ETR-LOQ
Title
Measurements
OG00068.2
OG00174.1
OG00233.6
OG00382.6
OG00451.5
OG00573.3
ETR-LOD
Title
Measurements
OG00061.8
OG00170.4
OG00231.8
OG003
OG005
Treatment C2A
ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
Units
Counts
Participants
OG00053
OG00149
OG00261
OG00353
OG00414
OG0057
Title
Denominators
Categories
End of Treatment (n = 53,49,60,53,14,7)
Title
Measurements
OG00077.4
OG00177.6
OG00259.0
OG00383.0
OG00435.7
OG00528.6
End of Study (n = 49,42,18,46,13,6)
Title
Measurements
OG00054.7
OG00161.2
OG00218.0
OG003
ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
OG005
Treatment C2A
ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
Units
Counts
Participants
OG000110
OG001108
OG002110
OG003109
OG00433
OG00530
Title
Denominators
Categories
Title
Measurements
OG00012.7
OG0019.3
OG0025.5
OG0032.8
OG0046.1
OG00510.0
OG005
Treatment C2A
ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.