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

This study has been terminated.
Information provided by (Responsible Party):
Debiopharm International SA Identifier:
First received: December 23, 2011
Last updated: June 30, 2016
Last verified: June 2016
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: 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 ]
    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 ]
    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 ]
    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 ]

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


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

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
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Please refer to this study by its identifier: NCT01500772

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

Responsible Party: Debiopharm International SA Identifier: NCT01500772     History of Changes
Other Study ID Numbers: CDEB025A2306
2011-004653-31 ( EudraCT Number )
Study First Received: December 23, 2011
Results First Received: May 19, 2016
Last Updated: June 30, 2016

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

Additional relevant MeSH terms:
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
Peginterferon alfa-2a
Protease Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents processed this record on May 24, 2017