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Pharmacokinetics, Pharmacodynamics and Safety of DEB025 Plus Ribavirin in Chronic Hepatitis C Genotype 2 and 3 Treatment naïve Patients

NCT ID: NCT01970904

Last Updated: 2016-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-03-31

Brief Summary

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This study will explore the relationship of different DEB025 doses in combination with RBV to pharmacokinetic, pharmacodynamic (i.e. viral load reduction) and safety profiles in chronic hepatitis C GT 2 and 3 treatment naïve patients.

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Detailed Description

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Conditions

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Hepatitis C Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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200 mg BID

Dual-therapy with a response-guided treatment duration with Alisporivir 200 mg twice daily (BID) and Ribavirin (RBV) for 12 or 24 weeks (Treatment period 1). Patients who were considered treatment failures were to be treated with peg-IFNα2a/RBV 800 mg daily for 24 weeks in Treatment period 2 (Roll-over treatment arm).

Group Type EXPERIMENTAL

Alisporivir

Intervention Type DRUG

Alisporivir 100 mg or 200 mg soft gel capsules (SGC) in blister packs for oral administration

Ribavirin

Intervention Type DRUG

Ribavirin tablets of various strengths for oral administration

Peg-IFNα2a

Intervention Type DRUG

Peg-IFNα2a solution for subcutaneous injection

300 mg BID

Dual-therapy with a response-guided treatment duration with Alisporivir 300mg BID and RBV for 12 or 24 weeks (Treatment period 1). Patients who were considered treatment failures were to be treated with peg-IFNα2a/RBV 800 mg daily for 24 weeks in Treatment period 2 (Roll-over treatment arm).

Group Type EXPERIMENTAL

Alisporivir

Intervention Type DRUG

Alisporivir 100 mg or 200 mg soft gel capsules (SGC) in blister packs for oral administration

Ribavirin

Intervention Type DRUG

Ribavirin tablets of various strengths for oral administration

Peg-IFNα2a

Intervention Type DRUG

Peg-IFNα2a solution for subcutaneous injection

400 mg BID

Dual-therapy with a response-guided treatment duration with Alisporivir 400 mg BID and RBV for 12 or 24 weeks (Treatment period 1). Patients who were considered treatment failures were to be treated with peg-IFNα2a/RBV 800 mg daily for 24 weeks in Treatment period 2 (Roll-over treatment arm).

Group Type EXPERIMENTAL

Alisporivir

Intervention Type DRUG

Alisporivir 100 mg or 200 mg soft gel capsules (SGC) in blister packs for oral administration

Ribavirin

Intervention Type DRUG

Ribavirin tablets of various strengths for oral administration

Peg-IFNα2a

Intervention Type DRUG

Peg-IFNα2a solution for subcutaneous injection

Interventions

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Alisporivir

Alisporivir 100 mg or 200 mg soft gel capsules (SGC) in blister packs for oral administration

Intervention Type DRUG

Ribavirin

Ribavirin tablets of various strengths for oral administration

Intervention Type DRUG

Peg-IFNα2a

Peg-IFNα2a solution for subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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DEB025 RBV

Eligibility Criteria

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Inclusion Criteria

1. Written informed consent must be obtained before any assessment is performed.
2. No previous treatment for Hepatitis C (HCV) infection (i.e. HCV treatment-naïve)
3. Chronic hepatitis C (G2 or G3) virus infection diagnosed

Exclusion Criteria

1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of that medication before enrollment.
2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
3. Hepatitis B Surface Antigen (HBsAg) positive
4. Human immunodeficiency virus (HIV) positive.

\-
Minimum Eligible Age

18 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

Berlin, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Cologne, , Germany

Site Status

Novartis Investigative Site

Düsseldorf, , Germany

Site Status

Novartis Investigative Site

Frankfurt, , Germany

Site Status

Novartis Investigative Site

Freiburg im Breisgau, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Hanover, , Germany

Site Status

Novartis Investigative Site

Kiel, , Germany

Site Status

Novartis Investigative Site

München, , Germany

Site Status

Novartis Investigative Site

Würzburg, , Germany

Site Status

Novartis Investigative Site

Bialystok, , Poland

Site Status

Novartis Investigative Site

Lublin, , Poland

Site Status

Novartis Investigative Site

Warsaw, , Poland

Site Status

Novartis Investigative Site

Gothenburg, , Sweden

Site Status

Novartis Investigative Site

Luleå, , Sweden

Site Status

Novartis Investigative Site

Lund, , Sweden

Site Status

Novartis Investigative Site

Malmo, , Sweden

Site Status

Novartis Investigative Site

Stockholm, , Sweden

Site Status

Novartis Investigative Site

Umeå, , Sweden

Site Status

Novartis Investigative Site

Frimley, Surrey, United Kingdom

Site Status

Novartis Investigative Site

Birmingham, , United Kingdom

Site Status

Novartis Investigative Site

London, , United Kingdom

Site Status

Novartis Investigative Site

London, , United Kingdom

Site Status

Countries

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Germany Poland Sweden United Kingdom

Other Identifiers

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2012-004185-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CDEB025A2222

Identifier Type: -

Identifier Source: org_study_id

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