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

Chronic Hepatitis C Infection Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02442271
• Other study ID #: M14-225
• Status: Completed
• Phase: Phase 3
• First received: May 11, 2015
• Last updated: September 27, 2016
• Start date: April 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

This is a Phase 3b, open-label, multicenter study 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 ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C Infection
• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Infection

Intervention

Drug:
• Ombitasvir/Paritaprevir/Ritonavir
Tablet
• Dasabuvir
Tablet
• Ribavirin
Tablet

Locations

Country	Name	City	State
Brazil	Site Reference ID/Investigator# 128884	Botucatu
Brazil	Site Reference ID/Investigator# 128882	Porto Alegre
Brazil	Site Reference ID/Investigator# 128891	Porto Alegre
Brazil	Site Reference ID/Investigator# 128880	Recife
Brazil	Site Reference ID/Investigator# 128885	Ribeirao Preto
Brazil	Site Reference ID/Investigator# 128888	Rio de Janeiro
Brazil	Site Reference ID/Investigator# 128889	Rio de Janeiro
Brazil	Site Reference ID/Investigator# 128892	Rio de Janeiro
Brazil	Site Reference ID/Investigator# 128886	Salvador
Brazil	Site Reference ID/Investigator# 136735	Santos
Brazil	Site Reference ID/Investigator# 128879	Sao Paulo
Brazil	Site Reference ID/Investigator# 128881	Sao Paulo
Brazil	Site Reference ID/Investigator# 128883	Sao Paulo
Brazil	Site Reference ID/Investigator# 128890	Sao Paulo
Brazil	Site Reference ID/Investigator# 129046	Sao Paulo
Brazil	Site Reference ID/Investigator# 129398	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants achieving sustained virologic response SVR12	Percentage of participants with HCV RNA < LLOQ 12 weeks post-treatment.	12 weeks after the last actual dose of study drug	No
Secondary	Percentage of participants achieving SVR12	The percentage of participants achieving SVR12 by fibrosis stage (F3 and F4), prior HCV treatment experience (naïve, or categories of prior Interferon(IFN)-based therapy, and IFN eligibility (ineligible, intolerant, eligible).	12 weeks after the last actual dose of study drug	No
Secondary	Change in general health-related quality of life using the HCV-Patient Related Outcome (HCV PRO) scores	The mean change in HCV PRO scores is assessed.	From Day 1 of study to 12 weeks after the last actual dose of the study drug	No
Secondary	Change in general health-related quality of life using the SF36V2 Physical Component Summary (PCS) scores	The mean change in SF-36V2 PCS scores is assessed.	From Day 1 of study to 12 weeks after the last actual dose of the study drug	No
Secondary	Change in general health-related quality of life using the SF36V2 Mental Component Summary (MCS) scores	The mean change in SF-36V2 MCS scores is assessed.	From Day 1 of study to 12 weeks after the last actual dose of the study drug	No