EUCTR2014-001496-31-ATActive, not recruitingPhase 1
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
AbbVie Deutschland GmbH & Co. KG0 sites160 target enrollmentStarted: September 24, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 160
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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.
Investigators
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