A randomized, open-label study to evaluate the safety and Effect of three experimental drugs ABT-450, ABT-267 and ABT-333 Coadministered with Ribavirin (RBV) in people with Genotype 1 hepatitis C Virus (HCV) and early liver damage. Experimental means that they have not been approved by any regulatory agency for sale to the public.

Active, not recruiting

• Conditions: Chronic Hepatitis C Infection and compensated cirrhosis; MedDRA version: 16.0Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-003088-23-BE
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-26
• Last Update Posted: 2015-08-17

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 381

Inclusion Criteria

1. Male or female and age is between 18 and 70 years, inclusive, at time of Screening.
2. Chronic HCV-infection prior to study enrollment. Chronic HCV-infection is defined as one of the following:
- Positive for anti-HCV antibody (Ab) or HCV RNA at least 6 months before Screening, and
- positive for HCV RNA and anti-HCV Ab at the time of Screening; or Positive for anti-HCV Ab and HCV RNA at the time of Screening with a liver biopsy consistent
with chronic HCV-infection (or a liver biopsy performed prior to enrollment with evidence of chronic hepatitis C disease).
3. Screening laboratory result indicating HCV genotype 1-infection.
4. Compensated cirrhosis defined as a Child-Pugh Score of = 6 at Screening
5. Subject has plasma HCV RNA level > 10,000 IU/mL at Screening.
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 342
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 38

Exclusion Criteria

-Positive screen for drugs or alcohol
-Significant sensitivity to any drug
-Use of contraindicated medications within 2 weeks of dosing
-Abnormal laboratory tests
-Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus antibody

Study & Design

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