Pharmacokinetics, Pharmacodynamics and Safety of DEB025 Plus Ribavirin in Chronic Hepatitis C Genotype 2 and 3 Treatment naïve Patients
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
2 other identifiers
interventional
147
4 countries
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2013
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedFirst Posted
Study publicly available on registry
October 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedApril 20, 2016
April 1, 2016
1.4 years
September 30, 2013
April 18, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Viral load drop from 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
within 12 weeks
Change in platelet count from baseline through Week 12.
Baseline through Week 12
Secondary Outcomes (1)
Number of participants with Sustained Virologic Response at Week 12 follow-up (SVR12)
12 weeks after the end of treatment
Study Arms (3)
200 mg BID
EXPERIMENTALDual-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).
300 mg BID
EXPERIMENTALDual-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).
400 mg BID
EXPERIMENTALDual-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).
Interventions
Alisporivir 100 mg or 200 mg soft gel capsules (SGC) in blister packs for oral administration
Ribavirin tablets of various strengths for oral administration
Eligibility Criteria
You may qualify if:
- Written informed consent must be obtained before any assessment is performed.
- No previous treatment for Hepatitis C (HCV) infection (i.e. HCV treatment-naïve)
- Chronic hepatitis C (G2 or G3) virus infection diagnosed
You may not qualify if:
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of that medication before enrollment.
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
- Hepatitis B Surface Antigen (HBsAg) positive
- Human immunodeficiency virus (HIV) positive.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Novartis Investigative Site
Berlin, 10969, Germany
Novartis Investigative Site
Berlin, 13353, Germany
Novartis Investigative Site
Cologne, 50937, Germany
Novartis Investigative Site
Düsseldorf, 40225, Germany
Novartis Investigative Site
Frankfurt, 60590, Germany
Novartis Investigative Site
Freiburg im Breisgau, 79106, Germany
Novartis Investigative Site
Hamburg, 20099, Germany
Novartis Investigative Site
Hamburg, 20246, Germany
Novartis Investigative Site
Hanover, 30625, Germany
Novartis Investigative Site
Kiel, 24146, Germany
Novartis Investigative Site
München, 81377, Germany
Novartis Investigative Site
Würzburg, 97080, Germany
Novartis Investigative Site
Bialystok, 15-540, Poland
Novartis Investigative Site
Lublin, 20-079, Poland
Novartis Investigative Site
Warsaw, 01-201, Poland
Novartis Investigative Site
Gothenburg, 416 85, Sweden
Novartis Investigative Site
Luleå, SE-971 80, Sweden
Novartis Investigative Site
Lund, 221 85, Sweden
Novartis Investigative Site
Malmo, SE-205 02, Sweden
Novartis Investigative Site
Stockholm, 141 86, Sweden
Novartis Investigative Site
Umeå, 901 85, Sweden
Novartis Investigative Site
Frimley, Surrey, GU16 7UJ, United Kingdom
Novartis Investigative Site
Birmingham, B15 2TT, United Kingdom
Novartis Investigative Site
London, E1 1BB, United Kingdom
Novartis Investigative Site
London, SE5 9RS, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2013
First Posted
October 28, 2013
Study Start
October 1, 2013
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
April 20, 2016
Record last verified: 2016-04