A multicentre, randomized, double-blind, placebocontrolled, parallel-group phase II study on efficacy and safety of DEB025 combined with peg-IFN alfa-2a and ribavirin in chronic hepatitis C genotype 1 relapsers and non-responders to previous peg-IFN plus ribavirin treatment

• Conditions: Chronic Hepatitis C Genotype 1 patients; MedDRA version: 14.1Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2010-020033-14-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-22
• Last Update Posted: 24 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 461

Inclusion Criteria

Chronic hepatitis C G1 viral infection Plasma HCV RNA level lower limit = 1,000 IU/ml assessed by qPCR (quantitative polymerase chain reaction)
or equivalent at screening; no upper limit; HCV genotype 1; Previous non-responders/ relapsers to SOC after treatment for at least 12 weeks.
other inclusion criteria may apply
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 442
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 19
;
Chronic hepatitis C G1 viral infection Plasma HCV RNA level lower limit = 1,000 IU/ml assessed by qPCR (quantitative polymerase chain reaction)
or equivalent at screening; no upper limit; HCV genotype 1; Previous non-responders/ relapsers to SOC after treatment for at least 12 weeks.
other inclusion criteria may apply
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 442
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 19

Exclusion Criteria

Treatment with any anti-HCV drug (whether approved or investigational) within 3 months prior to screening Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, UNLESS they are using a highly effective contraception.
other exclusion criteria may apply
;
Treatment with any anti-HCV drug (whether approved or investigational) within 3 months prior to screening Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, UNLESS they are using a highly effective contraception.
other exclusion criteria may apply

Study & Design

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