A Study of Pharmacokinetics, Efficacy, Safety, Tolerability, of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052), and Ribavirin (RBV) in Patients with Recurrent Chronic Hepatitis C Genotype 1b Infection after Orthotopic Liver Transplantatio

Phase 1

• Conditions: Hepatitis C Virus (HCV) genotype-1b Infection; MedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2013-002726-23-IT
• Lead Sponsor: Janssen R&D, Ireland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-24
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

- Liver transplant between 6 months and 10 years prior to the screening visit
-Hepatitis C virus (HCV) genotype 1 subtype b infection
- Screening HCV ribose nucleic acid level greater than 10,000 IU per milliliter
- HCV treatment-naïve participants must not have received post-OLT treatment with any approved or investigational drug for the treatment of HCV
- Receiving stable immunosuppressant therapy (ie, no change in dose in the last month) with cyclosporine or tacrolimus for more than 3 months prior to the screening visit
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 acute or chronic hepatic decompensation after the liver transplantation (including ascites, bleeding varices or hepatic encephalopathy)
- Any liver disease of non-HCV etiology, including current evidence of graft rejection except the presence of liver steatosis
- Any other clinically significant disease that in the opinion of the investigator would be exacerbated by the known effects of ribavarin
- Coinfection with HCV of another genotype than genotype 1b, HIV type 1 or 2 (positive HIV-1 or HIV-2 antibodies test at screening), and hepatitis B virus (hepatitis B surface antigen positive)
- Multi-organ transplant that included heart, lung, pancreas, or kidney

Study & Design

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