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

April 18, 2016 updated by: Debiopharm International SA

A Multicenter, Open-label, Randomized, 3-arm, Phase II Profiling Trial of Pharmacokinetics, Pharmacodynamics and Safety of DEB025/Alisporivir in Combination With Ribavirin Therapy in Chronic Hepatitis C Genotype 2 and 3 Treatment naïve Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

147

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Novartis Investigative Site
      • Berlin, Germany, 10969
        • Novartis Investigative Site
      • Duesseldorf, Germany, 40225
        • Novartis Investigative Site
      • Frankfurt, Germany, 60590
        • Novartis Investigative Site
      • Freiburg, Germany, 79106
        • Novartis Investigative Site
      • Hamburg, Germany, 20246
        • Novartis Investigative Site
      • Hamburg, Germany, 20099
        • Novartis Investigative Site
      • Hannover, Germany, 30625
        • Novartis Investigative Site
      • Kiel, Germany, 24146
        • Novartis Investigative Site
      • Köln, Germany, 50937
        • Novartis Investigative Site
      • Muenchen, Germany, 81377
        • Novartis Investigative Site
      • Würzburg, Germany, 97080
        • Novartis Investigative Site
  • Poland
      • Bialystok, Poland, 15-540
        • Novartis Investigative Site
      • Lublin, Poland, 20-079
        • Novartis Investigative Site
      • Warszawa, Poland, 01-201
        • Novartis Investigative Site
  • Sweden
      • Göteborg, Sweden, 416 85
        • Novartis Investigative Site
      • Luleå, Sweden, SE-971 80
        • Novartis Investigative Site
      • Lund, Sweden, 221 85
        • Novartis Investigative Site
      • Malmo, Sweden, SE-205 02
        • Novartis Investigative Site
      • Stockholm, Sweden, 141 86
        • Novartis Investigative Site
      • Umea, Sweden, 901 85
        • Novartis Investigative Site
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TT
        • Novartis Investigative Site
      • London, United Kingdom, SE5 9RS
        • Novartis Investigative Site
      • London, United Kingdom, E1 1BB
        • Novartis Investigative Site
    • Surrey
      • Frimley, Surrey, United Kingdom, GU16 7UJ
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: Alisporivir
Alisporivir 100 mg or 200 mg soft gel capsules (SGC) in blister packs for oral administration
Other Names:
  • DEB025
Drug: Ribavirin
Ribavirin tablets of various strengths for oral administration
Other Names:
  • RBV
Drug: Peg-IFNα2a
Peg-IFNα2a solution for subcutaneous injection
Experimental: 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).
Drug: Alisporivir
Alisporivir 100 mg or 200 mg soft gel capsules (SGC) in blister packs for oral administration
Other Names:
  • DEB025
Drug: Ribavirin
Ribavirin tablets of various strengths for oral administration
Other Names:
  • RBV
Drug: Peg-IFNα2a
Peg-IFNα2a solution for subcutaneous injection
Experimental: 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).
Drug: Alisporivir
Alisporivir 100 mg or 200 mg soft gel capsules (SGC) in blister packs for oral administration
Other Names:
  • DEB025
Drug: Ribavirin
Ribavirin tablets of various strengths for oral administration
Other Names:
  • RBV
Drug: Peg-IFNα2a
Peg-IFNα2a solution for subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Viral load drop from baseline through Week 12
Time Frame: Baseline through Week 12
Baseline through Week 12
Percentage of participants who developed confirmed Stage II or greater hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg
Time Frame: within 12 weeks
within 12 weeks
Change in platelet count from baseline through Week 12.
Time Frame: Baseline through Week 12
Baseline through Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with Sustained Virologic Response at Week 12 follow-up (SVR12)
Time Frame: 12 weeks after the end of treatment
12 weeks after the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Debiopharm International SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

September 30, 2013

First Submitted That Met QC Criteria

October 22, 2013

First Posted (Estimate)

October 28, 2013

Study Record Updates

Last Update Posted (Estimate)

April 20, 2016

Last Update Submitted That Met QC Criteria

April 18, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDEB025A2222
  • 2012-004185-17 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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