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Efficacy and Safety of Adding Alisporivir (DEB025) to Peginterferon (IFN) Alfa-2a (Peg-IFN Alfa-2a) and Ribavirin in Chronic HCV Genotype 1 Patients Who Relapsed or Did Not Respond to Previous Treatment

NCT ID: NCT01183169

Last Updated: 2016-08-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

459 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-05-31

Brief Summary

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The study is to investigate whether participants with hepatitis C virus (HCV) genotype 1 who have a history of non-response/relapse to peginterferon alfa-2a (PEG) and ribavirin (RBV) may benefit from treatment with triple therapy alisporivir (ALV; DEB025) with PEG and RBV versus placebo with PEG and RBV.

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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

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment A: ALV 600 mg QD

Alisporivir (ALV) 600 mg once daily (QD) with Peginterferon alfa-2a (PEG) and Ribavirin (RBV) for up to 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

Treatment B: ALV 800 mg QD

Alisporivir (ALV) 800 mg QD with PEG and RBV for up to 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

Treatment C1: ALV Placebo - 600 mg QD

ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving complete early virologic response (cEVR) after 12 weeks of treatment may switch to active ALV 600 mg QD with PEG and RBV.

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

Placebo

Intervention Type DRUG

ALV placebo soft gel capsules administered orally

Treatment C2: ALV Placebo - 400 mg BID

ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR after 12 weeks of treatment may switch to active ALV 400 mg twice daily (BID) with PEG and RBV.

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

Placebo

Intervention Type DRUG

ALV placebo soft gel capsules administered orally

Treatment D: ALV 400 mg BID

Alisporivir (ALV) 400 mg twice daily BID with PEG and RBV for up to 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

Placebo

ALV placebo soft gel capsules administered orally

Intervention Type DRUG

Other Intervention Names

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DEB025 ALV Pegasys® PEG Copegus® RBV ALV Placebo

Eligibility Criteria

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Inclusion Criteria

* Chronic HCV genotype 1 viral infection
* HCV RNA ≥ 1,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening
* Previous non-responders/relapsers to PEG and RBV after treatment for at least 12 weeks

Exclusion Criteria

* Treatment with any anti-HCV drug (whether approved or investigational) within 3 months prior to screening
* Women of child-bearing potential unless using highly effective
* Any other cause of relevant liver disease other than HCV
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

San Diego, California, United States

Site Status

Novartis Investigative Site

San Diego, California, United States

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Novartis Investigative Site

Ventura, California, United States

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Novartis Investigative Site

Bradenton, Florida, United States

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Orlando, Florida, United States

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Tampa, Florida, United States

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Honolulu, Hawaii, United States

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Honolulu, Hawaii, United States

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Springfield, Illinois, United States

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Topeka, Kansas, United States

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Springfield, Massachusetts, United States

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Egg Harbor Twp, New Jersey, United States

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Brooklyn, New York, United States

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New York, New York, United States

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Arlington, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Kingswood, New South Wales, Australia

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Kogarah, New South Wales, Australia

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Westmead, New South Wales, Australia

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Clayton, Victoria, Australia

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Fitzroy, Victoria, Australia

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Brussels, , Belgium

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Leuven, , Belgium

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Nice, , France

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Paris, , France

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Berlin, , Germany

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Cologne, , Germany

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Frankfurt, , Germany

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Freiburg im Breisgau, , Germany

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Hamburg, , Germany

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Leipzig, , Germany

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Békéscsaba, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Debrecen, , Hungary

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Kaposvár, , Hungary

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Székesfehérvár, , Hungary

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Antella - Bagno A Ripoli, FI, Italy

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Palermo, PA, Italy

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Padua, PD, Italy

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Parma, PR, Italy

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Roma, RM, Italy

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Bologna, , Italy

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Bialystok, , Poland

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Lódz, , Poland

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Warsaw, , Poland

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San Juan, , Puerto Rico

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Bucharest, District 1, Romania

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Bucharest, District 3, Romania

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Iași, Iaşi, Romania

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Bucharest, Romania, Romania

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Bucharest, , Romania

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Novartis Investigative Site

Seville, Andalusia, Spain

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Barcelona, Catalonia, Spain

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Barcelona, Catalonia, Spain

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Barcelona, Catalonia, Spain

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Madrid, Madrid, Spain

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Majadahonda, Madrid, Spain

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Novartis Investigative Site

Niaosong Township, Taiwan, Taiwan

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Novartis Investigative Site

Taipei, Taiwan, Taiwan

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Novartis Investigative Site

Taipei, Taiwan, ROC, Taiwan

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Novartis Investigative Site

Douliu, , Taiwan

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Novartis Investigative Site

Kaohsiung City, , Taiwan

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Novartis Investigative Site

Keelung, , Taiwan

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Novartis Investigative Site

Lin-Ko, , Taiwan

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Novartis Investigative Site

Ankara, Turkey, Turkey (Türkiye)

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Novartis Investigative Site

Ankara, Turkey, Turkey (Türkiye)

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Novartis Investigative Site

Izmir, Turkey, Turkey (Türkiye)

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Novartis Investigative Site

Fatih / Istanbul, , Turkey (Türkiye)

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Novartis Investigative Site

Nottingham, , United Kingdom

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Countries

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United States Australia Belgium France Germany Hungary Italy Poland Puerto Rico Romania Spain Taiwan Turkey (Türkiye) United Kingdom

Other Identifiers

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2010-020033-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CDEB025A2210

Identifier Type: -

Identifier Source: org_study_id

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