Trials / Completed
CompletedNCT01970904
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 147 (actual)
- Sponsor
- Debiopharm International SA · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Alisporivir | Alisporivir 100 mg or 200 mg soft gel capsules (SGC) in blister packs for oral administration |
| DRUG | Ribavirin | Ribavirin tablets of various strengths for oral administration |
| DRUG | Peg-IFNα2a | Peg-IFNα2a solution for subcutaneous injection |
Timeline
- Start date
- 2013-10-01
- Primary completion
- 2015-03-01
- Completion
- 2015-03-01
- First posted
- 2013-10-28
- Last updated
- 2016-04-20
Locations
25 sites across 4 countries: Germany, Poland, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT01970904. Inclusion in this directory is not an endorsement.