A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir Coadministered with Ribavirin in Adults with Genotype 4 Chronic Hepatitis C Virus Infection and Cirrhosis

Phase 1

Active, not recruiting

• Conditions: Hepatitis C Infection; MedDRA version: 17.0Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-001496-31-ES
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-03
• Last Update Posted: 2017-01-16

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

-Subjects must meet one of the following:
* Treatment-naive: Subject has never received antiviral treatment for hepatitis C infection OR
* Treatment Experienced (Prior null responders, Partial responders or Relapsers to IFN/RBV);
- Chronic HCV genotype 4 infection with cirrhosis.
- Subject has plasma HCV RNA level > 1,000 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 155
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

-Positive test result at Screening for Hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)
-Current enrollment in another interventional clinical study, previous enrollment in this study, or previous use of any protease inhibitor, non-nucleoside polymerase inhibitor, or NS5a inhibitor, either investigational or experimental (including previous exposure to ABT-450 or ombitasvir), or receipt of any investigational product within 6 weeks prior to study drug administration
-Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation including ascites, variceal bleeding, or hepatic encephalopathy
-Confirmed presence of hepatocellular carcinoma
-Any cause of liver disease other than chronic HCV infection
-Abnormal laboratory tests.

Study & Design

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