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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01970904

Enrollment

147

Registered

2013-10-28

Start date

2013-10-31

Completion date

2015-03-31

Last updated

2016-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Liver Disease

Keywords

Chronic hepatitis C, DEB025, Alisporivir, ribavirin therapy, genotype 2/3 treatment naive patients

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.

Interventions

DRUGAlisporivir

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

DRUGRibavirin

Ribavirin tablets of various strengths for oral administration

DRUGPeg-IFNα2a

Peg-IFNα2a solution for subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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. \-

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Germany, Poland, Sweden, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026