Completed
TURQUOISE-IIA 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)
What is being tested
ABT-450/r/ABT-267, ABT-333
+ Ribavirin (RBV)
+ ABT-450/r/ABT-267, ABT-333
Drug
Who is being recruted
Blood-Borne Infections+15
+ Chronic Disease
+ Communicable Diseases
From 18 to 70 Years
+11 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: October 2012
Summary
Principal SponsorAbbVie (prior sponsor, Abbott)
Last updated: July 12, 2021
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2012
Actual date on which the first participant was enrolled.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.
Principal SponsorAbbVie (prior sponsor, Abbott)
Last updated: July 12, 2021
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
381 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsChronic DiseaseCommunicable DiseasesDigestive System DiseasesHepatitisHepatitis, ChronicHepatitis, Viral, HumanInfectionsLiver DiseasesPathologic ProcessesRNA Virus InfectionsPathological Conditions, Signs and SymptomsVirus DiseasesFlaviviridae InfectionsDisease AttributesFibrosisHepatitis CHepatitis C, Chronic
Criteria
6 inclusion criteria required to participate
Chronic HCV-infection prior to study enrollment
Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at Screening
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
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5 exclusion criteria prevent from participating
A positive screening ultrasound for hepatocellular carcinoma (HCC) confirmed with a subsequent CT Scan or MRI during the screening period
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
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
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
Group II
ExperimentalABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers