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A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis | Clinical Trials | Clareo Health

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A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis

An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-III)

NCT02219503•AbbVie

View on ClinicalTrials.gov

Summary

The purpose of this study was to evaluate the safety and efficacy of ombitasvir/ paritaprevir/ ritonavir and dasabuvir in adults with genotype 1b chronic hepatitis C virus (HCV) infection and cirrhosis.

Detailed Description

This was a multicenter study evaluating the efficacy and safety of ombitasvir/ paritaprevir/ritonavir and dasabuvir administered for 12 weeks in HCV genotype 1b (GT1b)-infected, treatment-naïve and previous pegylated interferon (pegIFN)/ ribavirin (RBV) treatment-experienced adults with compensated cirrhosis. The duration of the study was up to 36 weeks (not including a screening period of up to 42 days) and consisted of a 12-week Treatment Period and a 24-week Post-Treatment Period for all participants who received study drugs.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Chronic HCV genotype 1-infection prior to study enrollment. Chronic HCV-infection is defined as the following:
•* Positive for anti-HCV antibody (Ab) or HCV RNA \> 1,000 IU/mL at least 6 months before Screening, and positive for HCV RNA and anti-HCV Ab at the time of Screening; or
•* HCV RNA \> 1,000 IU/mL at the time of Screening with a liver biopsy consistent with chronic HCV-infection (or a liver biopsy performed prior to enrollment with evidence of chronic hepatitis C disease).
•2. Screening laboratory result indicating HCV genotype 1b-infection.
•3. Compensated cirrhosis defined as a Child-Pugh Score of 5 or 6 at Screening.

Exclusion Criteria

•1. Women who are pregnant or breastfeeding.
•2. Positive test result for Hepatitis B surface antigen (HBsAg) or positive human immunodeficiency virus (HIV) antibody (confirmed by Western Blot).
•3. Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation such as ascites (noted on physical exam), variceal bleeding, or hepatic encephalopathy.
•4. Confirmed presence of hepatocellular carcinoma indicated on imaging techniques such as computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or on an ultrasound performed at Screening (a positive ultrasound result will be confirmed with CT scan or MRI.)
•5. Use of contraindicated medications within 2 weeks of dosing
•6. Screening laboratory analyses showing any of the following abnormal laboratory results:
•* Calculated creatinine clearance (using Cockcroft-Gault method) \< 30 mL/min
•* Albumin \< 2.8 g/dL
•* International normalized ratio (INR) \> 1.8. Participants with a known inherited blood disorder and INR \> 1.8 may be enrolled with permission of the AbbVie Study Designated Physician.
•* Hemoglobin \< 10 g/dL
+2 more criteria

Key Dates

Start Date

September 1, 2014

Primary Completion Date

June 1, 2015

Completion Date

September 1, 2015

Last Updated

July 12, 2021

Enrollment

ACTUAL participants

Conditions

Chronic Hepatitis C InfectionCompensated Cirrhosis

Interventions

Ombitasvir/Paritaprevir/Ritonavir

DRUG

Dasabuvir

DRUG

Validation of New Prognostic Biomarkers in Patients With Decompensated Cirrhosis

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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

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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 Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and 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

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