A Study to Evaluate the Safety and Effect of three experimental drugs ABT?450, ABT-267 and ABT-333 in combination with Ribavirin in people who have had a Liver Transplant and have Hepatitis C Virus (HCV) infection. Experimental means that they have not been approved by any regulatory agency for sale to the public.

Phase 1

Conditions: Chronic Hepatitis C Infection
MedDRA version: 15.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2012-004792-39-ES

Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

1. Male or female between the ages of 18 and 70 years, inclusive, at time of enrollment.
2. Liver transplantation as a consequence of HCV infection no less than 12 months before the Screening Visit.
3. A liver biopsy which shows evidence of fibrosis ? F2 (Metavir scale) within 3 months prior to or during the Screening Period.
4. Screening laboratory result indicating HCV genotype 1 infection.
5. Currently taking an immunosuppressant regimen based on either tacrolimus or cyclosporine where doses of immunosuppressant drugs have not been increased over the 3 months prior to Screening and no new drugs have been added for at least 3 months before Screening. Corticosteroids such as prednisone or prednisolone are permitted as components of the immunosuppressant regimen providing the dose is not more than 5 mg/day.
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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

- Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab).
- Clinically significant abnormalities, other than HCV infection in a subject post transplant, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG) that make the subject an unsuitable candidate for this study in the opinion of the investigator.
- Recent (within 6 months prior to study drugs administration) history of drug or alcohol abuse that, in the opinion of the investigator, could preclude adherence to the protocol.
- Previous use of any investigational or commercially available anti-HCV agent other than IFN-based therapy, i.e. conventional (c)IFN and/or pegylated (Peg) IFN, with or without RBV, including previous exposure to ABT-450, ABT-333 or ABT-267.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objectives of this study are to assess safety and efficacy (the percentage of subjects achieving a 12-week sustained virologic response, SVR12 (HCV ribonucleic acid [RNA] < lower limit of quantification [LLOQ] 12 weeks following treatment) of coformulated ABT-450/r and ABT-267 (ABT-450/r/ABT-267) and ABT-333 coadministered with RBV for 24 weeks in HCV genotype 1-infected adult liver transplant recipients.;Secondary Objective: The secondary objectives of this study are to assess the percentage of subjects achieving a 24-week sustained virologic response, SVR24 (HCV RNA < LLOQ 24 weeks following treatment), the percentage of subjects with virologic failure during treatment, and the percentage of subjects with relapse post-treatment.;Primary end point(s): The primary endpoint is the percentage of subjects with SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drugs).;Timepoint(s) of evaluation of this end point: 12 weeks after last dose of study drugs

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary endpoints are:<br>? The percentage of subjects with SVR24 (HCV RNA < LLOQ 24 weeks after the last actual dose of study drugs);<br>? The percentage of subjects with virologic failure during treatment;<br>? The percentage of subjects with post-treatment relapse.;Timepoint(s) of evaluation of this end point: Treatment Day 1 to end of treatment and end of treatment to 48 weeks post treatment.