Efficacy and Safety of Alisporivir Alone or Combined With... | NCT01215643 | Trialant
NCT01215643
Sponsor
Debiopharm International SA
Status
Completed
Last Update Posted
Aug 30, 2016Estimated
Enrollment
340Actual
Phase
Phase 2
Conditions
Hepatitis C
Chronic Pain
Interventions
Alisporivir
Peginterferon alfa-2a
Ribavirin
Countries
United States
Australia
Belgium
Canada
France
Germany
India
Italy
Poland
Puerto Rico
South Korea
Taiwan
Thailand
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01215643
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CDEB025A2211
Secondary IDs
ID
Type
Description
Link
2010-020034-26
EudraCT Number
Brief Title
Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants
Official Title
A Multicenter, Randomized, Open Label, Parallel-group Phase IIB Study on the Efficacy and Safety of Oral Regimens of DEB025 Alone or in Combination With Ribavirin Versus Standard of Care (Peg-IFNα2a Plus Ribavirin) in Treatment-naïve Hepatitis C Genotype 2 and 3 Patients
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
Oct 2010
Primary Completion Date
May 2012Actual
Completion Date
May 2012Actual
First Submitted Date
Oct 5, 2010
First Submission Date that Met QC Criteria
Oct 5, 2010
First Posted Date
Oct 6, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 20, 2016
Results First Submitted that Met QC Criteria
Jul 20, 2016
Results First Posted Date
Aug 30, 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 20, 2016
Last Update Posted Date
Aug 30, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Debiopharm International SAINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard of care (PEG+RBV) in treatment-naïve participants with hepatitis C virus (HCV) genotype 2 and 3. In addition, triple therapy with DEB025 plus standard of care will be applied to participants not achieving rapid viral response (RVR) in the different arms.
Detailed Description
Not provided
Conditions Module
Conditions
Hepatitis C
Chronic Pain
Keywords
Chronic hepatitis C genotype 2
Chronic hepatitis C genotype 3
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
340Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
ALV 1000 mg
Experimental
Alisporivir (ALV) 600 mg twice daily (BID) for 1 week, followed by ALV 1000 mg once daily (QD) during Weeks 2 to 24.
Drug: Alisporivir
ALV 600 mg+RBV
Experimental
Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with ribavirin (RBV) during Weeks 2 to 24.
Drug: Alisporivir
Drug: Ribavirin
ALV 800 mg+RBV
Experimental
Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
Drug: Alisporivir
Drug: Ribavirin
ALV 600 mg+PEG
Experimental
Alisporivir (ALV) 600 mg BID with Peginterferon alfa-2a (PEG) for 1 week, followed by ALV 600 mg QD with PEG once weekly during Weeks 2 to 24.
Drug: Alisporivir
Drug: Peginterferon alfa-2a
PEG+RBV
Active Comparator
Peginterferon alfa-2a (PEG) and RBV during Weeks 1 to 24.
Drug: Peginterferon alfa-2a
Drug: Ribavirin
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Alisporivir
Drug
ALV 200 mg soft gel capsules administered orally
ALV 1000 mg
ALV 600 mg+PEG
ALV 600 mg+RBV
ALV 800 mg+RBV
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ)
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.
after 4 weeks of treatment
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD)
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.
after 4 weeks of treatment
Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Chronic hepatitis C viral infection
Plasma HCV RNA level lower limit ≥ 10,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening (no upper limit)
HCV genotype 2 or 3
No previous treatment for hepatitis C infection
Exclusion criteria:
Evidence of cirrhosis at the time of screening
Evidence of hepatocellular carcinoma at the time of screening
Any other cause of relevant liver disease other than HCV
Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN)
Other protocol-defined inclusion/exclusion criteria may apply
Pawlotsky JM, Flisiak R, Sarin SK, Rasenack J, Piratvisuth T, Chuang WL, Peng CY, Foster GR, Shah S, Wedemeyer H, Hezode C, Zhang W, Wong KA, Li B, Avila C, Naoumov NV; VITAL-1 study team. Alisporivir plus ribavirin, interferon free or in combination with pegylated interferon, for hepatitis C virus genotype 2 or 3 infection. Hepatology. 2015 Oct;62(4):1013-23. doi: 10.1002/hep.27960. Epub 2015 Aug 10.
See Also Links
Not provided
Available IPD Information
Not provided
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
ALV 1000 mg
Alisporivir (ALV) 600 mg twice daily (BID) for 1 week, followed by ALV 1000 mg once daily (QD) during Weeks 2 to 24.
FG001
ALV 600 mg+RBV
ALV 600 mg BID with ribavirin (RBV) for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
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
Not provided
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
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
DEB025
ALV
Peginterferon alfa-2a
Drug
PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)
after 4 weeks of treatment
Percentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)
cEVR12LOQ and cEVR12LOD were defined as cEVR [serum HCV RNA < LOQ and < LOD] after 12 weeks of treatment, respectively.
after 12 weeks of treatment
Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)
after 12 weeks of treatment
Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)
after 12 weeks of treatment
Percentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)
ETR24LOQ and ETR24LOD were defined as ETR [serum HCV RNA < LOQ and < LOD] after 24 weeks of treatment or when prematurely discontinued.
at end of treatment, within 24 weeks
Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)
at end of treatment, within 24 weeks
Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)
at end of treatment, within 24 weeks
Percentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)
SVR12LOQ and SVR12LOD were defined as Sustained Viral Response (SVR) [serum HCV RNA < LOQ and < LOD] 12 weeks after treatment, respectively.
12 weeks after the end of treatment
Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)
12 weeks after the end of treatment
Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)
12 weeks after the end of treatment
Percentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)
24 weeks after the end of treatment
Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)
24 weeks after the end of treatment
Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)
24 weeks after the end of treatment
Percentage of Participants With On-treatment Viral Breakthrough
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
within 24 weeks of treatment
Percentage of Participants With Viral Relapse
Viral relapse was defined as having reappearance of detectable HCV RNA after previously being undetectable (< LOD) during treatment.
within 24 weeks after the end of treatment
San Diego
California
92101
United States
Research and Education Inc.
San Diego
California
92105
United States
Island View Gastroenterology Associates
Ventura
California
93003
United States
Hawai Medical Center East LLC
Honolulu
Hawaii
96817
United States
Cotton O'Neil Clinical Research
Topeka
Kansas
66606
United States
The Office of Dr. Claudia Martorell
Springfield
Massachusetts
01107
United States
Saint Louis University
St Louis
Missouri
63104
United States
Dartmouth-Hitchcock Medical Center
Lebanon
New Hampshire
03756-0001
United States
Weill Cornell Medical Center
New York
New York
10021
United States
Mount Sinai Medical Center
New York
New York
10029
United States
Columbia University Medical Center
New York
New York
10032
United States
The North Texas Research Institute
Arlington
Texas
76012
United States
Liver Associates of Texas
Houston
Texas
77030
United States
Liver Specialist of Texas
Houston
Texas
77030
United States
Alamo Medical Research
San Antonio
Texas
78215
United States
Novartis Investigative Site
Kingswood
New South Wales
2747
Australia
Novartis Investigative Site
Kogarah
New South Wales
2217
Australia
Novartis Investigative Site
Westmead
New South Wales
2145
Australia
Novartis Investigative Center
Greenslopes
Queensland
4120
Australia
Novartis Investigative Site
Clayton
Victoria
3168
Australia
Novartis Investigative Site
Fitzroy
Victoria
3065
Australia
Novartis Investigative Site
Brussels
1070
Belgium
Novartis Investigative Site
Ghent
9000
Belgium
Novartis Investigative Site
Leuven
3000
Belgium
Novartis Investigative Site
Vancouver
British Columbia
V5Z 1H2
Canada
Novartis Investigative Site
Toronto
Ontario
M4V 1P7
Canada
Novartis Investigative Site
Clichy
92118
France
Novartis Investigative Site
Créteil
94000
France
Novartis Investigative Site
Marseille
13008
France
Novartis Investigative Site
Paris
75006
France
Novartis Investigative Site
Berlin
10969
Germany
Novartis Investigative Site
Frankfurt
60590
Germany
Novartis Investigative Site
Freiburg im Breisgau
79095
Germany
Novartis Investigative Site
Hanover
30625
Germany
Novartis Investigative Site
Leipzig
04103
Germany
Novartis Investigative Site
Trivandrum
Kerala
695607
India
Novartis Investigative Site
Mumbai
Maharashtra
400036
India
Novartis Investigative Site
Ludhiana
Punjab
141001
India
Novartis Investigative Site
Lucknow
Uttar Pradesh
226014
India
Novartis Investigative Site
Guwahati
781006
India
Novartis Investigative Site
Haryāna
122001
India
Novartis Investigative Site
Hyderabad - Andhra Pradesh
500012
India
Novartis Investigative Site
Mumbai
400020
India
Novartis Investigative Site
New Delhi
110070
India
Novartis Investigative Site
Bologna
40138
Italy
Novartis Investigative Site
Brescia
25123
Italy
Novartis Investigative Site
Pavia
27100
Italy
Novartis Inestigative Site
Roma
00133
Italy
Novartis Investigative Site
Torino
10126
Italy
Novartis Investigative Site
Bialystok
15-540
Poland
Novartis Investigative Site
Lódz
91-347
Poland
Novartis Investigative Site
Warsaw
01 - 201
Poland
Fundacion de Investigacion de Diego
San Juan
00927
Puerto Rico
Novartis Korea Ltd.
Seoul
Seoul
120-752
South Korea
Novartis Inestigative Center
Pusan
602-739
South Korea
Novartis Investigative Site
Pusan
614-735
South Korea
Novartis Investigative Site
Seoul
738-736
South Korea
Novartis Investigative Site
Douliu
Taiwan
Novartis Investigative Site
Kaohsiung City
807
Taiwan
Novartis Investigative Site
Niaosong Township
83301
Taiwan
Novartis Investigative Site
Taichung
40447
Taiwan
Novartis Investigative Site
Taipei
10002
Taiwan
Novartis Investigative Site
Taipei
ROC112
Taiwan
Novartis Investigative Site
Bangkok
10700
Thailand
Novartis Investigative Site
Chiang Mai
50200
Thailand
Novartis Investigative Site
Songkhla
90110
Thailand
Novartis Investigative Site
Glasgow - Scotland
G12 OYN
United Kingdom
Novartis Investigative Site
London
E1 1BB
United Kingdom
Novartis Investigative Site
London
SE5 9RS
United Kingdom
Novartis Investigative Site
London
SW17 0QT
United Kingdom
Novartis Investigative Site
London
W2 1NY
United Kingdom
Novartis Investigative Site
Plymouth
PL6 8DH
United Kingdom
FG002
ALV 800 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
FG003
ALV 600 mg+PEG
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.
FG004
PEG+RBV
PEG and RBV during Weeks 1 to 24.
FG00083 subjects
FG00184 subjects
FG00294 subjects
FG00339 subjects
FG00440 subjects
COMPLETED
FG00074 subjects
FG00180 subjects
FG00282 subjects
FG00335 subjects
FG00429 subjects
NOT COMPLETED
FG0009 subjects
FG0014 subjects
FG00212 subjects
FG0034 subjects
FG00411 subjects
All randomized participants
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
ALV 1000 mg
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
BG001
ALV 600 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
BG002
ALV 800 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
BG003
ALV 600 mg+PEG
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
BG004
PEG+RBV
PEG and RBV during Weeks 1 to 24.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00083
BG00184
BG00294
BG00339
BG00440
BG005340
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
BG00040.2± 11.27
BG00142.8± 11.77
BG00242.6± 11.00
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00032
BG00128
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 Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ)
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.
Full Analysis Set (FAS), defined as all participants to whom study treatment was correctly assigned.
Posted
Number
percentage of participants
after 4 weeks of treatment
ID
Title
Description
OG000
ALV 1000 mg
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
OG001
ALV 600 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
OG002
ALV 800 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
OG003
ALV 600 mg+PEG
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
OG004
PEG+RBV
PEG and RBV during Weeks 1 to 24.
Units
Counts
Participants
OG00081
OG00184
OG00293
OG003
Title
Denominators
Categories
Title
Measurements
OG00028.4
OG00136.9
OG00241.9
OG003
Secondary
Percentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD)
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.
Full Analysis Set
Posted
Number
percentage of participants
after 4 weeks of treatment
ID
Title
Description
OG000
ALV 1000 mg
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
OG001
ALV 600 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
OG002
ALV 800 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
OG003
ALV 600 mg+PEG
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
OG004
Secondary
Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)
Participants in the Full Analysis Set with genotype 2 HCV infection
Posted
Number
percentage of participants
after 4 weeks of treatment
ID
Title
Description
OG000
ALV 1000 mg
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
OG001
ALV 600 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
OG002
ALV 800 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
OG003
ALV 600 mg+PEG
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
OG004
PEG+RBV
PEG and RBV during Weeks 1 to 24.
Secondary
Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)
Participants in the Full Analysis Set with genotype 3 HCV infection
Posted
Number
percentage of participants
after 4 weeks of treatment
ID
Title
Description
OG000
ALV 1000 mg
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
OG001
ALV 600 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
OG002
ALV 800 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
OG003
ALV 600 mg+PEG
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
OG004
PEG+RBV
PEG and RBV during Weeks 1 to 24.
Secondary
Percentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)
cEVR12LOQ and cEVR12LOD were defined as cEVR [serum HCV RNA < LOQ and < LOD] after 12 weeks of treatment, respectively.
Full Analysis Set
Posted
Number
percentage of participants
after 12 weeks of treatment
ID
Title
Description
OG000
ALV 1000 mg
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
OG001
ALV 600 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
OG002
ALV 800 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
OG003
ALV 600 mg+PEG
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
OG004
Secondary
Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)
Participants in the Full Analysis Set with genotype 2 HCV infection
Posted
Number
percentage of participants
after 12 weeks of treatment
ID
Title
Description
OG000
ALV 1000 mg
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
OG001
ALV 600 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
OG002
ALV 800 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
OG003
ALV 600 mg+PEG
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
OG004
PEG+RBV
PEG and RBV during Weeks 1 to 24.
Secondary
Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)
Participants in the Full Analysis Set with genotype 3 HCV infection
Posted
Number
percentage of participants
after 12 weeks of treatment
ID
Title
Description
OG000
ALV 1000 mg
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
OG001
ALV 600 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
OG002
ALV 800 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
OG003
ALV 600 mg+PEG
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
OG004
PEG+RBV
PEG and RBV during Weeks 1 to 24.
Secondary
Percentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)
ETR24LOQ and ETR24LOD were defined as ETR [serum HCV RNA < LOQ and < LOD] after 24 weeks of treatment or when prematurely discontinued.
Full Analysis Set
Posted
Number
percentage of participants
at end of treatment, within 24 weeks
ID
Title
Description
OG000
ALV 1000 mg
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
OG001
ALV 600 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
OG002
ALV 800 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
OG003
ALV 600 mg+PEG
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
OG004
Secondary
Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)
Participants in the Full Analysis Set with genotype 2 HCV infection
Posted
Number
percentage of participants
at end of treatment, within 24 weeks
ID
Title
Description
OG000
ALV 1000 mg
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
OG001
ALV 600 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
OG002
ALV 800 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
OG003
ALV 600 mg+PEG
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
OG004
PEG+RBV
PEG and RBV during Weeks 1 to 24.
Secondary
Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)
Participants in the Full Analysis Set with genotype 3 HCV infection
Posted
Number
percentage of participants
at end of treatment, within 24 weeks
ID
Title
Description
OG000
ALV 1000 mg
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
OG001
ALV 600 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
OG002
ALV 800 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
OG003
ALV 600 mg+PEG
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
OG004
PEG+RBV
PEG and RBV during Weeks 1 to 24.
Secondary
Percentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)
SVR12LOQ and SVR12LOD were defined as Sustained Viral Response (SVR) [serum HCV RNA < LOQ and < LOD] 12 weeks after treatment, respectively.
Full Analysis Set
Posted
Number
percentage of participants
12 weeks after the end of treatment
ID
Title
Description
OG000
ALV 1000 mg
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
OG001
ALV 600 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
OG002
ALV 800 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
OG003
ALV 600 mg+PEG
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
Secondary
Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)
Participants in the Full Analysis Set with genotype 2 HCV infection
Posted
Number
percentage of participants
12 weeks after the end of treatment
ID
Title
Description
OG000
ALV 1000 mg
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
OG001
ALV 600 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
OG002
ALV 800 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
OG003
ALV 600 mg+PEG
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
OG004
PEG+RBV
PEG and RBV during Weeks 1 to 24.
Secondary
Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)
Participants in the Full Analysis Set with genotype 3 HCV infection
Posted
Number
percentage of participants
12 weeks after the end of treatment
ID
Title
Description
OG000
ALV 1000 mg
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
OG001
ALV 600 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
OG002
ALV 800 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
OG003
ALV 600 mg+PEG
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
OG004
PEG+RBV
PEG and RBV during Weeks 1 to 24.
Secondary
Percentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)
Full Analysis Set
Posted
Number
percentage of participants
24 weeks after the end of treatment
ID
Title
Description
OG000
ALV 1000 mg
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
OG001
ALV 600 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
OG002
ALV 800 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
OG003
ALV 600 mg+PEG
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
OG004
PEG+RBV
PEG and RBV during Weeks 1 to 24.
Secondary
Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)
Participants in the Full Analysis Set with genotype 2 HCV infection
Posted
Number
percentage of participants
24 weeks after the end of treatment
ID
Title
Description
OG000
ALV 1000 mg
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
OG001
ALV 600 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
OG002
ALV 800 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
OG003
ALV 600 mg+PEG
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
OG004
PEG+RBV
PEG and RBV during Weeks 1 to 24.
Secondary
Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)
Participants in the Full Analysis Set with genotype 3 HCV infection
Posted
Number
percentage of participants
24 weeks after the end of treatment
ID
Title
Description
OG000
ALV 1000 mg
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
OG001
ALV 600 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
OG002
ALV 800 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
OG003
ALV 600 mg+PEG
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
OG004
PEG+RBV
PEG and RBV during Weeks 1 to 24.
Secondary
Percentage of Participants With On-treatment Viral Breakthrough
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
Full Analysis Set
Posted
Number
percentage of participants
within 24 weeks of treatment
ID
Title
Description
OG000
ALV 1000 mg
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
OG001
ALV 600 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
OG002
ALV 800 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
OG003
ALV 600 mg+PEG
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
Secondary
Percentage of Participants With Viral Relapse
Viral relapse was defined as having reappearance of detectable HCV RNA after previously being undetectable (< LOD) during treatment.
Full Analysis Set
Posted
Number
percentage of participants
within 24 weeks after the end of treatment
ID
Title
Description
OG000
ALV 1000 mg
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
OG001
ALV 600 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
OG002
ALV 800 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
OG003
ALV 600 mg+PEG
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
OG004
PEG+RBV
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
ALV 1000 mg: On-treatment AEs
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.
4
82
64
82
EG001
ALV 600 mg+RBV: On-treatment AEs
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.
1
84
69
84
EG002
ALV 800 mg+RBV: On-treatment AEs
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.
9
94
76
94
EG003
ALV 600 mg+PEG: On-treatment AEs
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.
4
39
37
39
EG004
PEG+RBV: On-treatment AEs
AEs occurring while on treatment in participants receiving PEG and RBV during Weeks 1 to 24.
2
37
30
37
EG005
ALV 1000 mg: Post-treatment AEs
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.
2
82
10
82
EG006
ALV 600 mg+RBV: Post-treatment AEs
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.
4
84
10
84
EG007
ALV 800 mg+RBV: Post-treatment AEs
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.
1
94
13
94
EG008
ALV 600 mg+PEG: Post-treatment AEs
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.
0
39
5
39
EG009
PEG+RBV: Post-treatment AEs
AEs occurring after end of treatment in participants receiving PEG and RBV during Weeks 1 to 24.
0
37
2
37
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute myocardial infarction
Cardiac disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected82 at risk
EG0010 affected84 at risk
EG0020 affected94 at risk
EG0030 affected39 at risk
EG0040 affected37 at risk
EG0050 affected82 at risk
EG0060 affected84 at risk
EG0071 affected94 at risk
EG0080 affected39 at risk
EG0090 affected37 at risk
Myocardial infarction
Cardiac disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected82 at risk
EG0010 affected84 at risk
EG0020 affected94 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected82 at risk
EG0010 affected84 at risk
EG0021 affected94 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected82 at risk
EG0010 affected84 at risk
EG0020 affected94 at risk
EG003
Retinopathy
Eye disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected82 at risk
EG0010 affected84 at risk
EG0020 affected94 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected82 at risk
EG0010 affected84 at risk
EG0020 affected94 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected82 at risk
EG0010 affected84 at risk
EG0020 affected94 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected82 at risk
EG0010 affected84 at risk
EG0021 affected94 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected82 at risk
EG0010 affected84 at risk
EG0020 affected94 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected82 at risk
EG0010 affected84 at risk
EG0021 affected94 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected82 at risk
EG0010 affected84 at risk
EG0021 affected94 at risk
EG003
Muscle abscess
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0001 affected82 at risk
EG0010 affected84 at risk
EG0020 affected94 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected82 at risk
EG0010 affected84 at risk
EG0020 affected94 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected82 at risk
EG0010 affected84 at risk
EG0020 affected94 at risk
EG003
Tubo-ovarian abscess
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected82 at risk
EG0010 affected84 at risk
EG0020 affected94 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected82 at risk
EG0010 affected84 at risk
EG0021 affected94 at risk
EG003
Alcohol poisoning
Injury, poisoning and procedural complications
MedDRA (15.0)
Systematic Assessment
EG0000 affected82 at risk
EG0010 affected84 at risk
EG0020 affected94 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA (15.0)
Systematic Assessment
EG0000 affected82 at risk
EG0010 affected84 at risk
EG0020 affected94 at risk
EG003
Maternal exposure during pregnancy
Injury, poisoning and procedural complications
MedDRA (15.0)
Systematic Assessment
EG0000 affected82 at risk
EG0010 affected84 at risk
EG0021 affected94 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA (15.0)
Systematic Assessment
EG0000 affected82 at risk
EG0010 affected84 at risk
EG0020 affected94 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected82 at risk
EG0010 affected84 at risk
EG0021 affected94 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected82 at risk
EG0010 affected84 at risk
EG0020 affected94 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected82 at risk
EG0011 affected84 at risk
EG0020 affected94 at risk
EG003
Hepatic neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)