Overview

This trial is active, not recruiting.

Condition chronic hepatitis c virus (hcv) infection genotype 1
Treatments abt-450/r/abt-267, abt-333, ribavirin (rbv)
Phase phase 3
Sponsor AbbVie
Start date June 2014
End date March 2020
Trial size 600 participants
Trial identifier NCT02167945, M14-222

Summary

The purpose of this study is to evaluate Long-term Outcomes following treatment with ABT-450/r/ABT-267, ABT-333 with or without RBV in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ABT-450/r/ABT-267 and ABT-333 coadministered with or without ribavirin (RBV) for 12 or 24 weeks
abt-450/r/abt-267
tablet
abt-333
tablet
ribavirin (rbv)
tablet

Primary Outcomes

Measure
Incidence of pre-defined clinical outcomes observed during the study
time frame: Up to Post-Treatment week 260 after the subject has taken his/her first dose of study drug

Secondary Outcomes

Measure
Percentage of subjects with sustained virologic response 12 weeks post-treatment (SVR12)
time frame: 12 weeks after the last actual dose of study drug
Change in fatigue
time frame: From Day 1 to Post-Treatment Week 12 and Post-Treatment Week 24.
Change in Quality of Life
time frame: From Day 1 to Post-Treatment Week 12 and Post-Treatment Week 24.
Evaluation of adherence to study drug regimens
time frame: Up to Treatment Week 24

Eligibility Criteria

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

Inclusion Criteria: 1. Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control 2. Chronic hepatitis C, genotype 1-infection (HCV RNA level greater than 1,000 IU/mL at screening) 3. HCV genotype 1 infection per screening laboratory result Exclusion Criteria: 1. Use of contraindicated medications within 2 weeks of dosing 2. Abnormal laboratory tests 3. Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus Antibody 4. Clinical history of liver decompensation 5. Presence of hepatocellular carcinoma at screening

Additional Information

Official title An Open-Label, Multicenter Study to Evaluate Long-term Outcomes With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ II)
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AbbVie.