A Study to Evaluate the Safety and Effect of Co-administration of ABT-450 with Ritonavir (ABT-450/r) and ABT-267 in Adults with Chronic Hepatitis C Virus Infectio

• Conditions: Chronic Hepatitis C Infection; MedDRA version: 14.1Level: PTClassification code 10008909Term: Chronic hepatitisSystem Organ Class: 10019805 - Hepatobiliary disorders; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-005762-38-ES
• Lead Sponsor: Abbott GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-28
• Last Update Posted: 16 March 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1.Male or female between the age of 18 and 70 years, inclusive, at time of enrollment.
2.Subjects must meet one of the following categories:
?Never received antiviral treatment for hepatitis C infection;
?Documented null-response (received at least 10 weeks of pegIFN/RBV for the treatment of HCV and failure to achieve a 2 log10 IU/ml reduction in HCV RNA at week 12 (Week 10-16).
3.Body mass index (BMI) is ? 18 to < 38 kg/m2. BMI is calculated as weight measured in kilograms (kg) divided by the square of height measured in meters (m).
4.Chronic HCV genotype 1-infection for at least 6 months prior to study enrollment.
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 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1.History of severe, life-threatening or other significant sensitivity to any drug.
2.Females who are pregnant or breastfeeding.
3.Recent history of drug or alcohol abuse that could preclude adherence to the protocol.
4.Positive test result for hepatitis B surface antigen or anti-HIV antibodies.
5.Any current or past clinical evidence of cirrhosis such as ascites or esophageal varices, or prior biopsy showing cirrhosis.

Study & Design

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