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

NCT ID: NCT01500772

Last Updated: 2016-08-01

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-05-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Hepatitis C

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Alisporivir

ALV 400 mg twice daily (BID), plus PEG and RBV for 48 weeks

Group Type EXPERIMENTAL

Alisporivir

Intervention Type DRUG

ALV 200 mg soft gel capsules administered orally

Peginterferon alfa-2a

Intervention Type DRUG

PEG 180 μg administered via subcutaneous (s.c.) injection once weekly

Ribavirin

Intervention Type DRUG

RBV 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose

Interventions

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Alisporivir

ALV 200 mg soft gel capsules administered orally

Intervention Type DRUG

Peginterferon alfa-2a

PEG 180 μg administered via subcutaneous (s.c.) injection once weekly

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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DEB025 Pegasys® Copegus® RBV

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Debiopharm International SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Phoenix, Arizona, United States

Site Status

Novartis Investigative Site

Bakersfield, California, United States

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Los Angeles, California, United States

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Palo Alto, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Novartis Investigative Site

Ventura, California, United States

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Novartis Investigational site

Bradenton, Florida, United States

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Bradenton, Florida, United States

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Miami, Florida, United States

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Wellington, Florida, United States

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Chicago, Illinois, United States

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Baltimore, Maryland, United States

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Brockton, Massachusetts, United States

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Minneapolis, Minnesota, United States

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St Louis, Missouri, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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Cincinnati, Ohio, United States

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Providence, Rhode Island, United States

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Arlington, Texas, United States

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Dallas, Texas, United States

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Alexandria, Virginia, United States

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Newport News, Virginia, United States

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Vancouver, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Novartis Investigative Site

Clichy, , France

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Novartis Investigative Site

Créteil, , France

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Paris, , France

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Novartis Investigational Site

Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Cologne, , Germany

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Cologne, , Germany

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Düsseldorf, , Germany

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Düsseldorf, , Germany

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Frankfurt, , Germany

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Freiburg im Breisgau, , Germany

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Frieburg, , Germany

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Hamburg, , Germany

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Hanover, , Germany

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Heidelberg, , Germany

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Kiel, , Germany

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Novartis Investigational Site

Mainz, , Germany

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Mainz, , Germany

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Florence, FI, Italy

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Milan, MI, Italy

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Modena, MO, Italy

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Palermo, PA, Italy

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Padua, PD, Italy

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Roma, RM, Italy

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Novartis Investigative Site

Torino, TO, Italy

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Novartis Investigative Site

Bologna, , Italy

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Novartis Investigative Site

San Juan, , Puerto Rico

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Novartis Investigative Site

Barcelona, Barcelona, Spain

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Novartis Investigative Site

Majadanonda, Madrid, Spain

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Novartis Investigative Site

London, , United Kingdom

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Novartis Investigative Site

London, , United Kingdom

Site Status

Countries

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United States Canada France Germany Italy Puerto Rico Spain United Kingdom

Other Identifiers

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2011-004653-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CDEB025A2306

Identifier Type: -

Identifier Source: org_study_id

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