Back to resultsAlisporivir (Deb025) and Boceprevir Triple Therapies in African American Participants Not Previously Treated for Chronic Hepatitis C Genotype 1
Primary Purpose
Hepatitis C
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Alisporivir
Boceprevir
Peginterferon alfa-2a
Ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Chronic hepatitis C, Cyclophilin inhibitor
Eligibility Criteria
Inclusion criteria:
- Chronic HCV genotype 1 infection
- No previous treatment for HCV infection
- African American ethnicity
- Serum HCV RNA ≥ 1000 IU/ml, assessed by quantitative polymerase chain reaction or equivalent at screening visit, no upper limit
- A liver biopsy within 3 years prior to baseline
Exclusion criteria:
- HCV genotype different from genotype 1 or co-infection with other HCV genotype
- Co-infection with Hepatitis B or HIV
- Any other cause of relevant liver disease other than HCV
- Presence or history of hepatic decompensation
- Alanine aminotransferase (ALT) ≥ 10 times ULN, more than 1 episode of elevated bilirubin (> ULN) in past 6 months
Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- Novartis Investigational Site
- Novartis Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Alisporivir
Boceprevir
Arm Description
At the time of partial clinical hold, participants randomized to original treatment arms A and B (Alisporivir triple therapy arms with Peginterferon alfa-2a and Ribavirin) discontinued alisporivir treatment immediately while continuing their treatments with the other two therapies. These participants were combined into the same arm because they received the same dose of alisporivir 400 mg twice per day (BID) for the same duration. Amendment 1 offered them the opportunity to continue in the study receiving boceprevir triple therapy.
Participants randomized to boceprevir triple therapy with Peginterferon alfa-2a and Ribavirin (the original treatment arm C).
Outcomes
Primary Outcome Measures
Percentage of Participants That Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events
Secondary Outcome Measures
Percentage of Participants With Emergence of Resistant Mutations
Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 24 Weeks After the End of Treatment (SVR24)
SVR24 was defined as hepatitis C virus (HCV) RNA undetectable (by limit of detection) 24 weeks after end of treatment.
Full Information
NCT ID
NCT01446250
First Posted
September 26, 2011
Last Updated
November 18, 2016
Sponsor
Debiopharm International SA
1. Study Identification
Unique Protocol Identification Number
NCT01446250
Brief Title
Alisporivir (Deb025) and Boceprevir Triple Therapies in African American Participants Not Previously Treated for Chronic Hepatitis C Genotype 1
Official Title
A Randomized, Open Label Trial of the Safety and Efficacy of DEB025/Alisporivir in Combination With Pegylated Interferon-α2a and Ribavirin (Peg-INFα2a/RBV) and Boceprevir in Combination With Peg-INFα2a/RBV in African American Treatment-naïve Patients With Chronic Hepatitis C Genotype 1
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Study Start Date
December 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Debiopharm International SA
4. Oversight
5. Study Description
Brief Summary
This study will assess the safety and efficacy of alisporivir (ALV) and boceprevir (BOC), each in combination with Peginterferon alfa-2a (PEG) and Ribavirin (RBV), in African American participants who have never received treatment for their chronic hepatitis C (HCV) genotype 1 infection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Chronic hepatitis C, Cyclophilin inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alisporivir
Arm Type
Experimental
Arm Description
At the time of partial clinical hold, participants randomized to original treatment arms A and B (Alisporivir triple therapy arms with Peginterferon alfa-2a and Ribavirin) discontinued alisporivir treatment immediately while continuing their treatments with the other two therapies. These participants were combined into the same arm because they received the same dose of alisporivir 400 mg twice per day (BID) for the same duration. Amendment 1 offered them the opportunity to continue in the study receiving boceprevir triple therapy.
Arm Title
Boceprevir
Arm Type
Active Comparator
Arm Description
Participants randomized to boceprevir triple therapy with Peginterferon alfa-2a and Ribavirin (the original treatment arm C).
Intervention Type
Drug
Intervention Name(s)
Alisporivir
Other Intervention Name(s)
DEB025
Intervention Description
ALV 200 mg soft gel capsules administered orally
Intervention Type
Drug
Intervention Name(s)
Boceprevir
Other Intervention Name(s)
Victrelis®
Intervention Description
BOC 800 mg (4 x 200 mg soft gel capsules) administered orally
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2a
Other Intervention Name(s)
Pegasys®
Intervention Description
PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Copegus®
Intervention Description
RBV 200 mg tablets (weight-based dose: < 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose
Primary Outcome Measure Information:
Title
Percentage of Participants That Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events
Time Frame
within 48 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With Emergence of Resistant Mutations
Time Frame
within 48 weeks
Title
Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 24 Weeks After the End of Treatment (SVR24)
Description
SVR24 was defined as hepatitis C virus (HCV) RNA undetectable (by limit of detection) 24 weeks after end of treatment.
Time Frame
24 weeks post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Chronic HCV genotype 1 infection
No previous treatment for HCV infection
African American ethnicity
Serum HCV RNA ≥ 1000 IU/ml, assessed by quantitative polymerase chain reaction or equivalent at screening visit, no upper limit
A liver biopsy within 3 years prior to baseline
Exclusion criteria:
HCV genotype different from genotype 1 or co-infection with other HCV genotype
Co-infection with Hepatitis B or HIV
Any other cause of relevant liver disease other than HCV
Presence or history of hepatic decompensation
Alanine aminotransferase (ALT) ≥ 10 times ULN, more than 1 episode of elevated bilirubin (> ULN) in past 6 months
Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigational Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Novartis Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Alisporivir (Deb025) and Boceprevir Triple Therapies in African American Participants Not Previously Treated for Chronic Hepatitis C Genotype 1
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