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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Debiopharm International SA
ClinicalTrials.gov Identifier:
NCT01446250
First received: September 26, 2011
Last updated: November 18, 2016
Last verified: November 2016
  Purpose
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 Intervention Phase
Hepatitis C Drug: Alisporivir Drug: Boceprevir Drug: Peginterferon alfa-2a Drug: Ribavirin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Debiopharm International SA:

Primary Outcome Measures:
  • 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:
  • Percentage of Participants With Emergence of Resistant Mutations [ Time Frame: within 48 weeks ]
  • 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.


Enrollment: 8
Study Start Date: December 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446250

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     History of Changes
Other Study ID Numbers: CDEB025A2307
Study First Received: September 26, 2011
Results First Received: June 10, 2016
Last Updated: November 18, 2016

Keywords provided by Debiopharm International SA:
Chronic hepatitis C
Cyclophilin inhibitor

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2017