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Clinical Trials/EUCTR2014-001496-31-AT
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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