Alisporivir (Deb025) and Boceprevir Triple Therapies in African American Participants Not Previously Treated for Chronic Hepatitis C Genotype 1

• ClinicalTrials.gov Identifier: NCT01446250
• Recruitment Status: Terminated
• First Posted: October 5, 2011
• Results First Posted: January 16, 2017
• Last Update Posted: January 16, 2017
• Sponsor: Debiopharm International SA
• Information provided by (Responsible Party): Debiopharm International SA

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.

Condition or disease	Intervention/treatment	Phase
Hepatitis C	Drug: Alisporivir; Drug: Boceprevir; Drug: Peginterferon alfa-2a; Drug: Ribavirin	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: December 2011
• Actual Primary Completion Date: May 2013
• Actual Study Completion Date: May 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Alisporivir; 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.	Drug: Alisporivir; ALV 200 mg soft gel capsules administered orally; Other Name: DEB025; Drug: Peginterferon alfa-2a; PEG 180 μg administered via subcutaneous (s.c.) injection once weekly; Other Name: Pegasys®; Drug: Ribavirin; RBV 200 mg tablets (weight-based dose: < 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose; Other Name: Copegus®
Active Comparator: Boceprevir; Participants randomized to boceprevir triple therapy with Peginterferon alfa-2a and Ribavirin (the original treatment arm C).	Drug: Boceprevir; BOC 800 mg (4 x 200 mg soft gel capsules) administered orally; Other Name: Victrelis®; Drug: Peginterferon alfa-2a; PEG 180 μg administered via subcutaneous (s.c.) injection once weekly; Other Name: Pegasys®; Drug: Ribavirin; RBV 200 mg tablets (weight-based dose: < 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose; Other Name: Copegus®

Outcome Measures

Primary Outcome Measures :

1. 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 Measures :

1. Percentage of Participants With Emergence of Resistant Mutations [ Time Frame: within 48 weeks ]
2. Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 24 Weeks After the End of Treatment (SVR24) [ Time Frame: 24 weeks post-treatment ]
   SVR24 was defined as hepatitis C virus (HCV) RNA undetectable (by limit of detection) 24 weeks after end of treatment.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

Novartis Investigational Site

Beverly Hills, California, United States, 90211

United States, Maryland

Novartis Investigational Site

Baltimore, Maryland, United States, 21229

Sponsors and Collaborators

Debiopharm International SA

Investigators

• Study Director: Novartis Pharmaceticals; Novartis Pharmaceuticals

More Information

• Responsible Party: Debiopharm International SA
• ClinicalTrials.gov Identifier: NCT01446250
• Other Study ID Numbers: CDEB025A2307
• First Posted: October 5, 2011
• Results First Posted: January 16, 2017
• Last Update Posted: January 16, 2017
• Last Verified: November 2016

Keywords provided by Debiopharm International SA:

Chronic hepatitis C; Cyclophilin inhibitor

Additional relevant MeSH terms:

Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Virus Diseases; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Blood-Borne Infections; Communicable Diseases; Flaviviridae Infections; Ribavirin; Peginterferon alfa-2a; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antiviral Agents; Anti-Infective Agents