Skip to main content
OpenTrials
Completed

NCT Number: NCT01970904

Pharmacokinetics, Pharmacodynamics and Safety of DEB025 Plus Ribavirin 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Disease Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Novartis Investigative Site, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

-

Treatment and study plan

Alisporivir

Drug

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

Other names: DEB025

Ribavirin

Drug

Ribavirin tablets of various strengths for oral administration

Other names: RBV

Peg-IFNα2a

Drug

Peg-IFNα2a solution for subcutaneous injection

Primary outcomes

  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 outcomes

  1. Number of participants with Sustained Virologic Response at Week 12 follow-up (SVR12)

    Time frame: 12 weeks after the end of treatment

Sponsors and collaborators

Lead sponsor

Debiopharm International SA

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 28, 2013
Registry last updated
Apr 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.