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).

Phase 3

Completed

• Conditions: chronische hepatitis C-virusinfectie; Chronic Hepatitis C Virus Infection; infectious disease affecting primarily the liver; 10047438

• Registration Number: NL-OMON55830
• Lead Sponsor: AbbVie Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 21

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 medication 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary efficacy endpoint is the effect of response to treatment (assessed by<br /><br>SVR12) on clinical outcomes, based on subjects in this study and companion<br /><br>study TOPAZ II. The endpoint will be assessed by comparing the incidence of the<br /><br>following events between subjects who achieve SVR12 and those who do not using<br /><br>the Cox regression model:<br /><br>* All-cause death<br /><br>* Liver-related death<br /><br>* Liver decompensation<br /><br>* Liver transplantation<br /><br>* Hepatocellular carcinoma<br /><br>* Composite of any of the above outcomes</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoint analyses:<br /><br>* The long-term change from baseline in liver stiffness (as assessed by<br /><br>transient elastography<br /><br>[Fibroscan®]), when available, will be assessed by baseline fibrosis stage and<br /><br>sustained virologic<br /><br>response.<br /><br>* The percentage of subjects achieving SVR12 and 2-sided 95% confidence<br /><br>interval will be<br /><br>presented by baseline fibrosis score (F0-F1, F2, F3 and F4).</p><br>