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Alisporivir With pegIFN/RBV in Protease Inhibitor (PI) Treatment Failure Patients With Chronic Hepatitis C

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01500772
First received: December 23, 2011
Last updated: May 4, 2012
Last verified: May 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the overall efficacy, and safety profile, of triple combination therapy of DEB025/pegIFN/RBV in chronic hepatitis C patients who failed prior treatment with PI.


Condition Intervention Phase
Hepatitis C
 Drug: Alisporivir
 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:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • SVR12 [ Time Frame: 12 weeks after the end of treatment ] [ Designated as safety issue: No ]
    SVR12 is defined as HCV RNA laboratory value <LOQ, (Level of quantification) 12 weeks after the end of treatment. The assay used in this study has a reported LOQ of 25 IU/ml.


Secondary Outcome Measures:
  • SVR24 [ Time Frame: 24 weeks after the end of treatment ] [ Designated as safety issue: No ]
    SVR24 is defined as HCV RNA laboratory value <LOQ, (Level of quantification) 24 weeks after the end of treatment. The assay used in this study has a reported LOQ of 25 IU/ml

  • SVR12LOD [ Time Frame: 12 weeks after the end of treatment ] [ Designated as safety issue: No ]
    SVR12LOD is defined as HCV RNA laboratory value <LOD, 12 weeks after the end of treatment. The assay used in this study as a repoated LOD of 10 IU/ml.

  • Overall safety profile [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    The evaluation the overall safety profile will be measured by proportion of patients that discontinue study drug or require dose reduction or dose interruption due to treatment-emergent AEs.


Enrollment: 6
Study Start Date: February 2012
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alisporivir with peg-IFNα2a/RBV
PI failure patients with HCV GT1 will be enrolled into the study receiving DEB 025 (alsiporivir) 2 capsules (400 mg) BID, PegIFNα2a, 180 μg s.c. once weekly, and ribavirin, 1000 mg/day (<75 kg) or 1200 mg/day (≥75 kg) orally in two divided doses for 48 weeks
 Drug: Alisporivir
Patients will take two DEB025 200mg capsules twice per day along with a body weight managed dosage of RBV twice per day with an injection of peg/IFN once per week.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. HCV GT1 patients with previous PI treatment failure.
  2. Timing of the PI treatment. the minimum time from the last dose of previous PI treatment to the first dose of study medication is three months.
  3. Diagnosed Chronic hepatitis C virus infection
  4. Infection with HCV genotype 1

Exclusion criteria:

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

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01500772

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01500772     History of Changes
Other Study ID Numbers: CDEB025A2306, 2011-004653-31
Study First Received: December 23, 2011
Last Updated: May 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Hepatitis C
PI treatment failure
Hepatitis C patients who previously failed protease inhibitor (PI) treatment

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
 Protease Inhibitors
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 19, 2013