A double-blind, placebo-controlled study to evaluate the safety and effect of three experimental drugs ABT-450, ABT-267, and ABT-333 with or without ribavirin in people with hepatitis C virus (HCV) that have not been treated before. Experimental means that they have not been approved by any regulatory agency for sale to the public.

• Conditions: Chronic Hepatitis C Infection; MedDRA version: 14.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-003687-52-PL
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-20
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

-Males or females 18 and 70 years old, inclusive
-Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control
-Chronic hepatitis C, genotype 1b-infection (HCV RNA level greater than 10,000 IU/mL at screening)
-Subject has never received antiviral treatment for hepatitis C infection
-No evidence of liver cirhosis
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 360
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

-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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study are to compare the efficacy (SVR12) and safety of the combination of ABT-450/r/ABT-267 and ABT-333 administered with and without RBV for 12 weeks in treatment-naive HCV genotype 1b-infected adults without cirrhosis.;Secondary Objective: The secondary objectives of this study are to compare the percentage of subjects with a decrease in hemoglobin to below the lower limit of normal (LLN) while on treatment between treatment arms and to summarize the percentage of subjects with virologic failure during treatment and the percentage of subjects with relapse post-treatment in each of the treatment group.;Primary end point(s): 1. Percentage of subjects in each treatment group with sustained virologic response 12 weeks post-treatment.;Timepoint(s) of evaluation of this end point: 1. 12 weeks after last dose of study drug.

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 1. First dose of study drug until last dose of study drug.<br>2. Post-treatment Day 1 through post-treatment week 48. <br>3. Post-treatment Day 1 through post-treatment week 48.<br>;Secondary end point(s): 1. Changes in hemoglobin laboratory values during treatment.<br>2. Percentage of subjects with virologic failure during treatment.<br>3. Percentage of subjects with virologic relapse after treatment.