An open-label study to evaluate the safety and efficacy of three experimental drugs (Ombitasvir/ ABT-450/ Ritonavir and Dasabuvir) in people with genotype 1b hepatitis C virus (HCV) and early liver damage. "Experimental" means that they have not been approved by any regulatory agency for sale to the public.

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)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001953-18-BE

Enrollment

Registered

2014-08-12

Start date

2014-10-13

Completion date

Unknown

Last updated

2016-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C infection and compensated cirrhosis MedDRA version: 17.0 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: Ombitasvir/ABT-450/Ritonavir Product Code: ABT-267/ABT-450/r Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ABT-450 CAS Number: 1456607-71-8 Current Sponsor code: ABT-450 O

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Males or females at least 18 years of age at time of screening -Chronic hepatitis C, genotype 1-infection (HCV RNA level greater than or equal to 1,000 IU/mL at screening -HCV genotype 1b infection confirmed at screening -Compensated cirrhosis defined as Child Pugh A (score 5 or 6) at screening Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: -Women who are pregnant or breastfeeding -Significant sensitivity to any drug -Use of contraindicated medications within 2 weeks of dosing -Abnormal laboratory tests -Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus antibody

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objectives of this study are to compare the efficacy (the percentage of subjects achieving a 12-week sustained virologic response, SVR12 [HCV RNA < lower limit of quantification (LLOQ) 12 weeks following treatment]) of co-formulated ombitasvir/ABT-450/ritonavir and dasabuvir administered for 12 weeks to the historical SVR12 rate of sofosbuvir plus pegIFN/RBV and to assess the safety of the DAA combination regimen in HCV genotype 1b-infected adult subjects with compensated cirrhosis. ;Secondary Objective: The secondary objectives of this study are to assess the number and percentage of subjects with virologic failure during treatment and the percentage of subjects with virologic relapse.;Primary end point(s): The primary endpoint is the percentage of subjects with SVR12 ;Timepoint(s) of evaluation of this end point: 12 weeks after last dose of study drug	—

Measure

Time frame

Main Objective: The primary objectives of this study are to compare the efficacy (the percentage of subjects achieving a 12-week sustained virologic response, SVR12 [HCV RNA < lower limit of quantification (LLOQ) 12 weeks following treatment]) of co-formulated ombitasvir/ABT-450/ritonavir and dasabuvir administered for 12 weeks to the historical SVR12 rate of sofosbuvir plus pegIFN/RBV and to assess the safety of the DAA combination regimen in HCV genotype 1b-infected adult subjects with compensated cirrhosis. ;Secondary Objective: The secondary objectives of this study are to assess the number and percentage of subjects with virologic failure during treatment and the percentage of subjects with virologic relapse.;Primary end point(s): The primary endpoint is the percentage of subjects with SVR12 ;Timepoint(s) of evaluation of this end point: 12 weeks after last dose of study drug

—

Secondary

Measure	Time frame
Secondary end point(s): a. The percentage of subjects with on-treatment virologic failure (rebound or failure to suppress) b. The percentage of subjects with post-treatment relapse (up to and including the SVR12 assessment time point).;Timepoint(s) of evaluation of this end point: a. 12 weeks after first dose of study drug b. 12 weeks after last dose of study drug	—

Countries

Belgium, Canada, United States

Contacts

Public ContactEU Clinical Trials Helpdesk

AbbVie Ltd.

eu-clinical-trials@abbvie.com+441628773355

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026