A study to evaluate the safety and effect of the 2 experimental drugs ABT-493/ABT-530 in people with HCV. "Experimental" means that they have not been approved by any regulatory agency for sale to the public.

A Randomized, Double-Blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults with Chronic Hepatitis C Virus Genotype 2 Infection (ENDURANCE-2)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002348-14-BE

Enrollment

321

Registered

2015-09-14

Start date

2015-11-06

Completion date

Unknown

Last updated

2017-08-21

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

Conditions

Chronic HCV Infection MedDRA version: 18.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: ABT-493/ABT-530 Product Code: ABT-493/ABT-530 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ABT-493 Current Sponsor code: ABT-493 Other descriptive name: ABT-493 Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male or female at least 18 years of age at time of screening. - Screening laboratory result indicating HCV GT2 infection. - Chronic HCV infection. - Subject must be HCV treatment-naïve or has failed prior IFN or pegIFN with or without RBV, or SOF plus RBV with or without PegIFN therapy. - Subjects must be non-cirrhotic. 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 276 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45

Exclusion criteria

Exclusion criteria: - History of severe, life-threatening or other significant sensitivity to any excipient of the study drugs. - Female who is pregnant, planning to become pregnant during the study or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study. - Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator. - Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab). - HCV genotype performed during screening indicating co-infection with more than one HCV genotype.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objectives of this study are to assess the efficacy (SVR12) HCV RNA < lower limit of quantification (LLOQ) 12 weeks following 12 weeks of treatment of the ABT-493/ABT-530 combination regimen and the safety of 12 weeks of treatment with the ABT-493/ABT-530 combination regimen compared to placebo, in adults with chronic HCV genotype (GT) 2 infection without underlying cirrhosis.;Secondary Objective: The percentage of subjects treated with the ABT-493/ABT-530 combination regimen with on-treatment virologic failure during the Double-Blind Treatment Period. The percentage of subjects treated with the ABT-493/ABT-530 combination regimen with post-treatment relapse following the Double-Blind Treatment Period.;Primary end point(s): The primary efficacy endpoint is the percentage of subjects with SVR12, excluding prior SOF + RBV ± pegIFN failures.;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 assess the efficacy (SVR12) HCV RNA < lower limit of quantification (LLOQ) 12 weeks following 12 weeks of treatment of the ABT-493/ABT-530 combination regimen and the safety of 12 weeks of treatment with the ABT-493/ABT-530 combination regimen compared to placebo, in adults with chronic HCV genotype (GT) 2 infection without underlying cirrhosis.;Secondary Objective: The percentage of subjects treated with the ABT-493/ABT-530 combination regimen with on-treatment virologic failure during the Double-Blind Treatment Period. The percentage of subjects treated with the ABT-493/ABT-530 combination regimen with post-treatment relapse following the Double-Blind Treatment Period.;Primary end point(s): The primary efficacy endpoint is the percentage of subjects with SVR12, excluding prior SOF + RBV ± pegIFN failures.;Timepoint(s) of evaluation of this end point: 12 weeks after last dose of study drug

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Secondary

Measure	Time frame
Secondary end point(s): - The percentage of subjects, excluding prior SOF + RBV ± pegIFN failures, with virologic failure during treatment. - The percentage of subjects, excluding prior SOF + RBV ± pegIFN failures, with post-treatment relapse. - The percentage of subjects with prior SOF + RBV ± pegIFN failure with SVR12.;Timepoint(s) of evaluation of this end point: - At The end of treatment (last dose of study drug in The trial)	—

Measure

Time frame

Secondary end point(s): - The percentage of subjects, excluding prior SOF + RBV ± pegIFN failures, with virologic failure during treatment. - The percentage of subjects, excluding prior SOF + RBV ± pegIFN failures, with post-treatment relapse. - The percentage of subjects with prior SOF + RBV ± pegIFN failure with SVR12.;Timepoint(s) of evaluation of this end point: - At The end of treatment (last dose of study drug in The trial)

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Countries

Belgium, Korea, Republic of, Lithuania, Portugal, Taiwan, 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