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Trial record 44 of 382 for:    IFNA2 AND RBV AND genotype

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

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ClinicalTrials.gov Identifier: NCT01970904
Recruitment Status : Completed
First Posted : October 28, 2013
Last Update Posted : April 20, 2016
Sponsor:
Information provided by (Responsible Party):
Debiopharm International SA

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatitis C Liver Disease Drug: Alisporivir Drug: Ribavirin Drug: Peg-IFNα2a Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin

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 Name: DEB025

Drug: Ribavirin
Ribavirin tablets of various strengths for oral administration
Other Name: 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 Name: DEB025

Drug: Ribavirin
Ribavirin tablets of various strengths for oral administration
Other Name: 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 Name: DEB025

Drug: Ribavirin
Ribavirin tablets of various strengths for oral administration
Other Name: RBV

Drug: Peg-IFNα2a
Peg-IFNα2a solution for subcutaneous injection




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

Secondary Outcome Measures :
  1. Number of participants with Sustained Virologic Response at Week 12 follow-up (SVR12) [ Time Frame: 12 weeks after the end of treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01970904


Locations
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Germany
Novartis Investigative Site
Berlin, Germany, 10969
Novartis Investigative Site
Berlin, Germany, 13353
Novartis Investigative Site
Duesseldorf, Germany, 40225
Novartis Investigative Site
Frankfurt, Germany, 60590
Novartis Investigative Site
Freiburg, Germany, 79106
Novartis Investigative Site
Hamburg, Germany, 20099
Novartis Investigative Site
Hamburg, Germany, 20246
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
Poland
Novartis Investigative Site
Bialystok, Poland, 15-540
Novartis Investigative Site
Lublin, Poland, 20-079
Novartis Investigative Site
Warszawa, Poland, 01-201
Sweden
Novartis Investigative Site
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
United Kingdom
Novartis Investigative Site
Frimley, Surrey, United Kingdom, GU16 7UJ
Novartis Investigative Site
Birmingham, United Kingdom, B15 2TT
Novartis Investigative Site
London, United Kingdom, E1 1BB
Novartis Investigative Site
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Debiopharm International SA
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Debiopharm International SA
ClinicalTrials.gov Identifier: NCT01970904     History of Changes
Other Study ID Numbers: CDEB025A2222
2012-004185-17 ( EudraCT Number )
First Posted: October 28, 2013    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016
Keywords provided by Debiopharm International SA:
Chronic hepatitis C
DEB025
Alisporivir
ribavirin therapy
genotype 2/3 treatment naive patients
Additional relevant MeSH terms:
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Ribavirin
Interferon alpha-2
Interferon-alpha
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Peginterferon alfa-2a
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs