Clinical trial NCT02442271: A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs in Adults With Hepatitis C Virus Infection, Who Are Either Treatment-naive or Treatment-experienced in Brazil
Official title: An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in Treatment-Naïve or Treatment-Experienced Adults in Brazil With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ III)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C Infection
Keywords: Chronic Hepatitis C
Hepatitis C Treatment Naive
Hepatitis C Genotype 1
Hepatitis C Treatment Experienced
Hepatitis C Virus
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-05-13
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the proportion of subjects achieving sustained virologic response 12 weeks post-treatment (SVR12) in adults with genotype 1 (GT1) chronic HCV infection, who received treatment with 3 direct-acting antiviral agents (3-DAAs; ombitasvir/paritaprevir/ritonavir and dasabuvir) with or without ribavirin.


Eligibility criteria: Inclusion Criteria:

* Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control
* Males must be surgically sterile or agree to practice acceptable forms of birth control
* Chronic hepatitis C virus (HCV) infection at screening
* Fibrosis stage F3 or greater, documented by acceptable tests
* Participants with cirrhosis: Absence of hepatocellular carcinoma (HCC) as indicated by acceptable methods

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Positive test result for Hepatitis B surface antigen (HbsAg) or anti-HIV antibody positive (HIV Ab)
* Use of contraindicated medications within 2 weeks of dosing
* Clinically significant abnormalities or co-morbidities
* History of solid organ transplant
* Abnormal laboratory tests
* Current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
timeFrame: 12 weeks after the last actual dose of study drug
Secondary outcomes:
measure: Percentage of Participants With SVR12 by Fibrosis Stage
timeFrame: 12 weeks after the last actual dose of study drug
measure: Percentage of Participants With SVR12 by Participant Prior HCV Treatment Experience
timeFrame: 12 weeks after the last actual dose of study drug
measure: Percentage of Participants With SVR12 by Participant Eligibility for Treatment With Interferon (IFN) at Screening
timeFrame: 12 weeks after the last actual dose of study drug
measure: Hepatitis C Virus Patient-Reported Outcomes Instrument (HCV-PRO) Total Score: Change From Baseline to 12 Weeks After the Last Dose of Study Drug
timeFrame: Day 1 (Baseline), 12 weeks after the last actual dose of the study drug
measure: Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Scores: Change From Baseline to 12 Weeks After the Last Dose of Study Drug
timeFrame: Day 1 (Baseline), 12 weeks after the last actual dose of the study drug
measure: (SF-36v2) Mental Component Summary (MCS) Scores: Change From Baseline to 12 Weeks After the Last Dose of Study Drug
timeFrame: Day 1 (Baseline), 12 weeks after the last actual dose of the study drug
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: AbbVie Inc
role: STUDY_DIRECTOR
References: