Overview

This trial is active, not recruiting.

Conditions chronic hepatitis c, hepatitis c virus, hcv
Treatment abt-493/abt-530
Phase phase 3
Sponsor AbbVie
Start date October 2015
End date January 2017
Trial size 620 participants
Trial identifier NCT02604017, 2015-002087-17, M13-590

Summary

This study seeks to evaluate the efficacy and safety of ABT-493/ABT-530 in participants with Genotype 1 hepatitis C virus infection without cirrhosis

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ABT-493/ABT-530 for 12 weeks in HCV genotype 1 infected participants without cirrhosis
abt-493/abt-530
Tablets
(Experimental)
ABT-493/ABT-530 for 8 weeks in HCV genotype 1 infected participants without cirrhosis
abt-493/abt-530
Tablets

Primary Outcomes

Measure
Percentage of participants achieving a 12-week sustained virologic response (SVR12) Post-treatment in the intent-to-treat (ITT) mono-infected HCV GT1 population
time frame: 12 weeks after last dose of study drug
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment in the 8-week Arm compared to the 12-week Arm in the per protocol (PP) ITT mono-infected HCV GT1 population.
time frame: 12 weeks after last dose of study drug
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment in the 8-week Arm compared to the 12-week Arm in the ITT mono-infected HCV GT1 population.
time frame: 12 weeks after last dose of study drug

Secondary Outcomes

Measure
Percentage of participants achieving a 12-week sustained virologic response (SVR12) Post-treatment in the ITT mono-infected HCV GT1 population
time frame: 12 weeks after last dose of study drug
Percentage of participants achieving a 12-week sustained virologic response (SVR12) Post-treatment in the ITT population
time frame: 12 weeks after last dose of study drug
Percentage of participants achieving a 12-week sustained virologic response (SVR12) Post-treatment among subjects with HCV GT1/HIV-1 co-infection
time frame: 12 weeks after last dose of study drug
Percentage of participants with on-treatment virologic failure
time frame: Up to 8 or 12 weeks while on treatment
Percentage of participants with Post-Treatment relapse
time frame: Up to 12 weeks after the last dose of study drug

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

Inclusion Criteria: 1. Male or female, at least 18 years of age at time of screening. 2. Screening laboratory result indicating HCV GT1 infection. 3. Chronic HCV infection. 4. Subject must be HCV treatment-naïve (i.e., patient has never received a single dose of any approved or investigational regimen) or treatment-experienced (has failed prior IFN or pegIFN with or without RBV, or SOF plus RBV with or without pegIFN therapy). 5. Subjects must be non-cirrhotic. Additional Inclusion Criteria for GT1 HCV/HIV-1 co-infected patients: 6. HIV-1 ART naïve with CD4 ≥ 500 cells/mm3 (or CD4+ % ≥ 29%) at Screening and plasma HIV-1 RNA <1,000 copies/mL at Screening and at least once during the 12 months prior to Screening. Or On a stable, qualifying HIV-1 ART regimen for at least 8 weeks prior to screening, with CD4 ≥ 200 cells/mm3 (or CD4+ % ≥14%) at Screening and plasma HIV-1 RNA < LLOQ at Screening and at least once during the 12 months prior to Screening. Exclusion Criteria: 1. History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs. 2. 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. 3. 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. 4. Positive test result at Screening for hepatitis B surface antigen (HBsAg). 5. HCV genotype performed during screening indicating co-infection with more than one HCV genotype. 6. Chronic human immunodeficiency virus, type 2 (HIV-2) infection.

Additional Information

Official title A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1 Infection (ENDURANCE-1)
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AbbVie.