A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir With Sofosbuvir With and Without Ribavirin in Adults With Chronic Hepatitis C Virus Infection



Status:Recruiting
Conditions:Infectious Disease, Infectious Disease, Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 99
Updated:4/21/2016
Start Date:December 2014
End Date:June 2017
Contact:Malin Folmerz
Email:malin.folmerz@abbvie.com
Phone:+46 8-68444600

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A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of the Co-Administration of Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) With Sofosbuvir (SOF) With or Without Ribavirin (RBV) in Subjects With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection or Genotype 3 HCV Infection With or Without Cirrhosis

The purpose of this study is to evaluate the safety and efficacy of ombitasvir/ABT-450/r
with sofusbuvir with or without ribavirin in adults with Genotype 2 Chronic Hepatitis C
Virus (HCV)infection or Genotype 3 HCV infection With or Without Cirrhosis.


Inclusion Criteria:

1. Chronic HCV infection prior to study enrollment.

2. Screening laboratory results from the central clinical laboratory indicating HCV
genotype 2 or 3 infection only (no mixed genotype).

3. Absence OR presence of cirrhosis.

4. If cirrhotic, need to have compensated cirrhosis and absence of hepatocellular
carcinoma (HCC)

Exclusion Criteria:

1. Positive screen for hepatitis B surface antigen or anti-human immunodeficiency virus
antibody

2. Recent (within 6 months prior to study drug administration) history of drug or
alcohol abuse.

3. Current enrollment in another clinical study, previous enrolment in this study, or
previous use of any investigational or commercially available anti-HCV therapy (other
than interferon, pegIFN, RBV, and or SOF) including previous exposure to telaprevir,
boceprevir, ABT-450, or ombitasvir (ABT-267).

4. Subjects without cirrhosis: Any current or past clinical evidence of cirrhosis.

5. Abnormal lab tests.

6. Females who are pregnant or plan to become pregnant or breastfeeding, or males whose
partners are pregnant or planning to become pregnant
We found this trial at
3
sites
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Los Angeles, CA
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Adelaide,
Principal Investigator: Site Reference ID/Investigator# 132014, MD
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Adelaide,
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Atlanta, GA
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