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 November 2014
End date January 2017
Trial size 1650 participants
Trial identifier NCT02219490, 2014-001022-14, M14-423


The purpose of this study is to evaluate Long-term outcomes following treatment with ABT-450/r/ABT-267 and 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
ABT-450/r/ABT-267 and ABT-333 coadministered with or without ribavirin (RBV) for 12 or 24 weeks
ribavirin (rbv)

Primary Outcomes

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 last dose of study drug.

Secondary Outcomes

Change in fibrosis
time frame: Up to Post-Treatment week 260 after the subject has taken his/her last dose of study drug
Percentage of subjects with sustained virologic response 12 weeks post-treatment (SVR12)
time frame: 12 weeks after the last actual dose of study drug

Eligibility Criteria

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

Inclusion Criteria: 1. Males and females at least 18 years old at screening 2. Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control 3. Chronic hepatitis C, genotype 1 infection 4. Males must be surgically sterile or agree to practice acceptable forms of birth control 5. Screening laboratory result indicating HCV genotype 1 infection Exclusion Criteria: 1. Use of contraindicated medications within 2 weeks of dosing 2. Abnormal laboratory tests 3. Current or past clinical evidence of Child-Pugh B or C classification or history of liver decompensation 4. Confirmed presence of hepatocellular carcinoma 5. History of solid organ transplant

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-I)
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AbbVie.