Efficacy and Safety Study of Simeprevir in Combination with Sofosbuvir in Subjects with Chronic Genotype 4 Hepatitis C Virus Infectio

• Conditions: Hepatitis C-Infection genotype 4 Patients; MedDRA version: 17.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-003446-27-ES
• Lead Sponsor: Janssen R&D Ireland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-20
• Last Update Posted: 18 January 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

.Subjects with confirmed hepatitis C virus (HCV) with HCV RNA greater than (>) 10000 international unit per milliliter (IU/mL)
.Subjects who are treatment naive or treatment-experienced.
.Subjects must have documentation of a liver biopsy or fibroscan or agree to have one during screening
.Subjects with cirrhosis must have an hepatic imaging procedure (ultrasound, CT scan or magnetic resonance imaging [MRI]) within 6 months before the screening visit (or during the screening period) with no findings suspicious for hepatocellular carcinoma (HCC)
.Women of childbearing potential or men with a female partner of childbearing potential must agree to use an effective form of contraception, or not be heterosexually active, or of nonchildbearing potential
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 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

.Evidence of clinical hepatic decompensation
.Any liver disease of non-HCV etiology
.Subjects with a past history of treatment with an approved or investigational DAA - Co-infection with human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test at screening)
.Infection/co-infection with HCV non-genotype 4

Study & Design

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