Overview

This trial has been completed.

Conditions chronic hepatitis c, hepatitis c (hcv), hepatitis c genotype 1a
Treatments ombitasvir/abt-450/ritonavir, dasabuvir, ribavirin
Phase phase 2
Sponsor AbbVie
Start date June 2015
End date April 2016
Trial size 46 participants
Trial identifier NCT02493855, 2014-001478-32, M14-242

Summary

This is a study of ombitasvir/ABT-450/ritonavir and dasabuvir with low dose ribavirin (RBV), full dose RBV or RBV add on in treatment naive subjects with chronic Hepatitis C Virus (HCV).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Ombitasvir/ABT-450/r once daily (QD) + dasabuvir twice daily (BID) for 12 weeks + weight-based RBV (1000 mg or 1200 mg split BID) for the last 10 weeks
ombitasvir/abt-450/ritonavir ABT-267/ABT-450/ritonavir
ombitasvir/ABT-450/ritonavir tablets
dasabuvir ABT-333
dasabuvir tablets
ribavirin
ribavirin tablets
(Experimental)
Ombitasvir/ABT-450/r once daily (QD) + dasabuvir twice daily (BID) + weight-based RBV (1000 mg or 1200 mg split BID) for 12 weeks
ombitasvir/abt-450/ritonavir ABT-267/ABT-450/ritonavir
ombitasvir/ABT-450/ritonavir tablets
dasabuvir ABT-333
dasabuvir tablets
ribavirin
ribavirin tablets
(Experimental)
Ombitasvir/ABT-450/r once daily (QD) + dasabuvir twice daily (BID) + RBV 600 mg QD for 12 weeks
ombitasvir/abt-450/ritonavir ABT-267/ABT-450/ritonavir
ombitasvir/ABT-450/ritonavir tablets
dasabuvir ABT-333
dasabuvir tablets
ribavirin
ribavirin tablets

Primary Outcomes

Measure
Slope of the second phase decline in plasma HCV RNA levels during treatment
time frame: From Week 0 to Week 2

Eligibility Criteria

Male or female participants from 18 years up to 100 years old.

Inclusion Criteria: 1. Screening laboratory result indicating HCV genotype 1 (GT1) a infection. 2. Chronic HCV infection. 3. Subjects must be non-cirrhotic. 4. Subjects must be able to understand and adhere to the study visit schedule and all protocol requirements as well as voluntarily sign and date an institutional review board (IRB) approved informed consent. Exclusion Criteria: 1. Women who are pregnant or breastfeeding. 2. Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab) positive immunoassay. 3. Clinically significant abnormalities or co-morbidities, other than HCV infection, that make the subject unsuitable for this study or treatment. 4. Current enrollment in another interventional clinical study. Previous use of any HCV treatments including pegylated interferon (pegIFN), ribavirin, or any direct acting antiviral agent, either investigational or approved, for HCV including protease inhibitors, nucleoside or non-nucleoside polymerase inhibitors, or NS5A inhibitors. 5. History or solid organ transplant. 6. Screening laboratory analysis that shows abnormal results.

Additional Information

Official title An Exploratory Study to Evaluate the Kinetics of Viral Load Decline With Ombitasvir/ABT 450/Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naïve Adults With Genotype 1a Chronic Hepatitis C Virus (HCV) Infection
Description A study to evaluate the effect of RBV on second phase plasma HCV ribonucleic acid (RNA) decline in subjects who receive ombitasvir/ABT-450/ritonavir and dasabuvir with full dose RBV compared to ombitasvir/ABT-450/ritonavir with low dose RBV or without RBV in treatment-naive HCV genotype (GT) 1a-infected adult subjects.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by AbbVie.