Overview

This trial is active, not recruiting.

Condition chronic hepatitis c virus infection
Treatments ombitasvir/abt-450/r, sofosbuvir, ribavirin (rbv)
Phase phase 2
Sponsor AbbVie
Start date December 2014
End date July 2017
Trial size 70 participants
Trial identifier NCT02292719, 2014-003147-35, M14-567

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Ombitasvir/ABT-450/r and sofosbuvir (SOF) once daily for 12 weeks
ombitasvir/abt-450/r
Tablet
sofosbuvir Sovaldi
Tablet
(Experimental)
Ombitasvir/ABT-450/r with sofosbuvir (SOF) once daily and ribavirin twice daily for 12 weeks
ombitasvir/abt-450/r
Tablet
sofosbuvir Sovaldi
Tablet
ribavirin (rbv)
Tablet
(Experimental)
Ombitasvir/ABT-450/r with sofosbuvir (SOF) once daily and ribavirin twice daily for 8 weeks
ombitasvir/abt-450/r
Tablet
sofosbuvir Sovaldi
Tablet
ribavirin (rbv)
Tablet
(Experimental)
Ombitasvir/ABT-450/r with sofosbuvir (SOF) once daily and ribavirin twice daily for 6 weeks
ombitasvir/abt-450/r
Tablet
sofosbuvir Sovaldi
Tablet
ribavirin (rbv)
Tablet
(Experimental)
Ombitasvir/ABT-450/r with sofosbuvir (SOF) once daily and ribavirin twice daily for 12 weeks
ombitasvir/abt-450/r
Tablet
sofosbuvir Sovaldi
Tablet
ribavirin (rbv)
Tablet
(Experimental)
Ombitasvir/ABT-450/r and sofosbuvir (SOF) once daily for 12 weeks
ombitasvir/abt-450/r
Tablet
sofosbuvir Sovaldi
Tablet

Primary Outcomes

Measure
Percentage of participants with sustained virologic response 12 weeks (SVR12) post-treatment
time frame: 12 weeks after the last dose of active drug

Secondary Outcomes

Measure
Percentage of participants with on-treatment virologic failure
time frame: Up to Week 12
Percentage of participants with virologic relapse after treatment
time frame: Up to 12 weeks after the last actual dose of active study drug

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AbbVie.