Efficacy and safety study of DEB025/Alisporivir combined to Peg-IFN and Ribavirin in chronic hepatitis C genotype 1 naïve patients.

Phase 1

• Conditions: Chronic Hepatitis C genotype 1 treatment-naïve patients; MedDRA version: 15.0Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2010-022867-37-GB
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-23
• Study Completion: 2013-08-13
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1077

Inclusion Criteria

-Chronic hepatitis C viral
-HCV genotype
-no previous treatment for hepatitis C infection
-Serum HCV RNA level = 1000 IU/ml assessed by quantitative polymerase chain reaction or equivalent at screening, no upper limit.
-liver evaluation prior to Baseline: liver biopsy within 3 years or Fibroscan within 6 months.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1010
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

Key exclusion criteria are :

-HCV genotype different from genotype 1 or co-infection with other HCV genotype.
-co-infection with Hepatitis B or HIV
-Any other cause of relevant liver disease other than HCV
-Presence or history of hepatic decompensation
-ALT = 10 times ULN,
- more than 1 episode of elevated bilirubin (>ULN) in past 6 months
Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to demonstrate that in treatment-naïve chronic hepatitis C genotype 1 patients triple therapy with DEB025 plus peg-IFNa2a/RBV leads to a superior SVR12 rate as compared to dual therapy<br>with peg-IFNa2a/RBV.;Secondary Objective: The key secondary objective is to confirm the results of the primary analysis, using SVR 24 instead of SVR 12.;Primary end point(s): Sustained Viral Response Week 12 (SVR 12) defined as serum HCV RNA below limit of quantification (LOQ) 12 weeks after treatment completion;Timepoint(s) of evaluation of this end point: 12 weeks after treatment completion