Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Alisporivir With PEG and RBV in Protease Inhibitor (PI) Treatment Failure Patients With Chronic Hepatitis C

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Debiopharm International SA
ClinicalTrials.gov Identifier:
NCT01500772
First received: December 23, 2011
Last updated: June 30, 2016
Last verified: June 2016
  Purpose
This study is to evaluate the overall efficacy, and safety profile of the triple combination therapy of alisporivir (ALV; DEB025) plus peginterferon alfa-2a (PEG) and ribavirin (RBV) patients with chronic hepatitis C (HCV) genotype 1 who failed prior treatment with a protease inhibitor (PI).

Condition Intervention Phase
Hepatitis C
Drug: Alisporivir
Drug: Peginterferon alfa-2a
Drug: Ribavirin
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Single-arm Trial Evaluating the Safety and Efficacy of DEB025/Alisporivir in Combination With Pegylated Interferon-α2a and Ribavirin (Peg-IFNα2a/RBV) in Protease Inhibitor Treatment Failure 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 Who Achieved Sustained Viral Response (SVR) 12 Weeks After End of Treatment (SVR12) [ Time Frame: 12 weeks posttreatment ] [ Designated as safety issue: No ]
    SVR12 was defined as hepatitis C (HCV) ribonucleic acid (RNA) laboratory value below level of quantification (LOQ) (i.e., 25 IU/ml) 12 weeks after the end of treatment.


Secondary Outcome Measures:
  • Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24) [ Time Frame: 24 weeks posttreatment ] [ Designated as safety issue: No ]
    SVR24 was defined as HCV RNA laboratory value < LOQ 24 weeks after the end of treatment.

  • Percentage of Participants With HCV RNA Laboratory Value Below Level of Detection 12 Weeks After the End of Treatment (SVR12-LOD) [ Time Frame: 12 weeks posttreatment ] [ Designated as safety issue: No ]
    Level of detection (LOD) was defined as 10 IU/mL

  • Percentage of Participants Who Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: March 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alisporivir
ALV 400 mg twice daily (BID), plus PEG and RBV for 48 weeks
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 Names:
  • Copegus®
  • RBV

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Patients with chronic HCV genotype 1 infection with previous PI treatment failure
  2. Three months minimum time from the last dose of previous PI treatment to the first dose of study medication

Exclusion criteria:

  1. Use of other investigational drugs at the time of enrollment
  2. History of hypersensitivity to PEG or RBV
  3. Any null non-responders to prior PEG/RBV treatment

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: NCT01500772

  Show 60 Study Locations
Sponsors and Collaborators
Debiopharm International SA
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Debiopharm International SA
ClinicalTrials.gov Identifier: NCT01500772     History of Changes
Other Study ID Numbers: CDEB025A2306  2011-004653-31 
Study First Received: December 23, 2011
Results First Received: May 19, 2016
Last Updated: June 30, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Debiopharm International SA:
Hepatitis C
PI treatment failure

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
Protease Inhibitors
HIV Protease Inhibitors
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on December 09, 2016