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A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis

A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-II)

NCT01704755•AbbVie (prior sponsor, Abbott)

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults with compensated cirrhosis.

Detailed Description

During the treatment period of the study, participants received treatment with ABT-450/ritonavir/ABT-267 and ABT-333 coadministered with RBV for either 12 or 24 weeks. Upon completing the treatment period or premature discontinuation of the treatment period, participants entered a 48-week post-treatment period.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
•Male or female between 18 and 70 years, inclusive, at time of Screening.
•Chronic HCV-infection prior to study enrollment.
•Screening laboratory result indicating HCV genotype 1-infection.
•Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at Screening
•Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening.

Exclusion Criteria

•Significant liver disease with any cause other than HCV as the primary cause
•Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab) at screening.
•Prior therapy with direct acting antiviral agents for the treatment of HCV, including telaprevir and boceprevir.
•Any current or past clinical evidence of Child-Pugh B or C Classification or clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding or hepatic encephalopathy.
•A positive screening ultrasound for hepatocellular carcinoma (HCC) confirmed with a subsequent CT Scan or MRI during the screening period.

Key Dates

Start Date

October 1, 2012

Primary Completion Date

January 1, 2014

Completion Date

September 1, 2014

Last Updated

July 12, 2021

Enrollment

381

ACTUAL participants

Conditions

Chronic Hepatitis C InfectionCompensated Cirrhosis

Interventions

ABT-450/r/ABT-267, ABT-333

DRUG

Ribavirin (RBV)

DRUG

Validation of New Prognostic Biomarkers in Patients With Decompensated Cirrhosis

NCT06855056

Liver CirrhosisDecompensated Cirrhosis of Liver

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RECRUITINGNA

Carvedilol + Simvastatin vs. Carvedilol Alone for Cirrhosis and Cirrhotic Cardiomyopathy and Impact on Hepatic Decompensation and Survival

NCT06431919

Decompensated CirrhosisCirrhotic Cardiomyopathy+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 12, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis

Inclusion Criteria

Exclusion Criteria

Validation of New Prognostic Biomarkers in Patients With Decompensated Cirrhosis

Carvedilol + Simvastatin vs. Carvedilol Alone for Cirrhosis and Cirrhotic Cardiomyopathy and Impact on Hepatic Decompensation and Survival

A Study to See if an Investigational Medicine Called VS-01 Can Help and How Safe it is in the Treatment of Patients With Overt Hepatic Encephalopathy

Incidence & Predictive Factors of Recompensation in Children With Decompensated Cirrhosis as Per the Baveno VII Criteria

A Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of HCL001 Cell Injection (Homologous Allogeneic Hepatocytes) in Patients With Decompensated Cirrhosis

Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIV