A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Subjects With Genotype 1 Infection

July 9, 2021 updated by: AbbVie

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

703

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, at least 18 years of age at time of screening.
  • Screening laboratory result indicating hepatitis C virus (HCV) genotype 1 (GT1) infection.
  • Chronic HCV infection.
  • 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 interferon [IFN] or pegylated IFN (pegIFN) with or without ribivarin (RBV), or sofosbuvir (SOF) plus RBV with or without pegIFN therapy).
  • Subjects must be non-cirrhotic.

Additional Inclusion Criteria for HCV GT1/human immununovirus type 1 (HIV-1) co-infected patients:

  • HIV-1 antiretroviral treatment (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:

  • History of severe, life-threatening or other significant sensitivity to any excipients 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).
  • HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
  • Chronic HIV type 2 (HIV-2) infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABT-493/ABT-530 for 12 weeks
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Drug: ABT-493/ABT-530
Tablet; ABT-493 coformulated with ABT-530
Other Names:
  • ABT-493 also known as glecaprevir
  • ABT-530 also known as pibrentasvir
  • MAVYRET
Experimental: ABT-493/ABT-530 for 8 weeks
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
Drug: ABT-493/ABT-530
Tablet; ABT-493 coformulated with ABT-530
Other Names:
  • ABT-493 also known as glecaprevir
  • ABT-530 also known as pibrentasvir
  • MAVYRET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Mono-infected Hepatitis C Virus Genotype 1 (HCV GT1), Direct-acting Antiviral Agent (DAA) Naïve Participants in the 12-Week Treatment Arm
Time Frame: 12 weeks after the last actual dose of study drug
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of participants who achieved SVR12 in the 12-week treatment group compared with the historical control rate for HCV GT1 subjects who are treatment-naïve or treated with pegylated-interferon alfa-2a or alfa-2b and ribavirin (pegIFN/RBV).
12 weeks after the last actual dose of study drug
Percentage of Participants With SVR12: Noninferiority of 8-Week Arm to 12-Week Arm in Mono-infected HCV GT1, DAA-Naïve Participants, Excluding Those Who Discontinued/Experienced Virologic Failure by Week 8 or Had No HCV RNA Value at Week 12 or Later
Time Frame: 12 weeks after last actual dose of study drug
SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of mono-infected HCV GT1, DAA-naïve participants (excluding those who discontinued/experienced virologic failure by Week 8 or had no HCV RNA value at Week 12 or later) who achieved SVR12 in the 8-week treatment arm compared with the 12-week treatment arm.
12 weeks after last actual dose of study drug
Percentage of Participants With SVR12: Noninferiority of 8-Week Treatment Arm to 12-Week Treatment Arm in Mono-infected HCV GT1, DAA-Naïve Participants
Time Frame: 12 weeks after the last actual dose of study drug
SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of mono-infected HCV GT1, DAA-naïve participants who achieved SVR12 in the 8-week treatment arm compared with the 12-week treatment arm.
12 weeks after the last actual dose of study drug

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With SVR12 in Mono-infected HCV GT1 Participants
Time Frame: 12 weeks after last actual dose of study drug
SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug.
12 weeks after last actual dose of study drug
Percentage of Participants With SVR12
Time Frame: 12 weeks after last actual dose of study drug
SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug.
12 weeks after last actual dose of study drug
Percentage of Participants With SVR12 in Co-infected HCV GT1/Human Immunodeficiency Virus Type 1 (HIV-1) Participants
Time Frame: 12 weeks after last actual dose of study drug
SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug.
12 weeks after last actual dose of study drug
Percentage of Participants With SVR12 in HCV GT1-infected, Prior Sofosbuvir (SOF) Treatment-Experienced Participants
Time Frame: 12 weeks after last actual dose of study drug
SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug.
12 weeks after last actual dose of study drug
Percentage of Participants With On-treatment Virologic Failure
Time Frame: Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment
On-treatment virologic failure was defined as confirmed increase of >1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥100 IU/mL after HCV RNA <LLOQ during treatment, or HCV RNA ≥LLOQ at end of treatment with at least 6 weeks of treatment.
Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment
Percentage of Participants With On-treatment Virologic Failure in Mono-infected HCV GT1, DAA-Naïve Participants
Time Frame: Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment
On-treatment virologic failure was defined as confirmed increase of >1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥100 IU/mL after HCV RNA <LLOQ during treatment, or HCV RNA ≥LLOQ at end of treatment with at least 6 weeks of treatment.
Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment
Percentage of Participants With Post-treatment Relapse
Time Frame: From the end of treatment through 12 weeks after the last dose of study drug
Post-treatment relapse was defined as confirmed HCV RNA ≥LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels <LLOQ at the end of treatment, excluding reinfection.
From the end of treatment through 12 weeks after the last dose of study drug
Percentage of Participants With Post-treatment Relapse in Mono-infected HCV GT1, DAA-Naïve Participants
Time Frame: From the end of treatment through 12 weeks after the last dose of study drug
Post-treatment relapse was defined as confirmed HCV RNA ≥LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels <LLOQ at the end of treatment, excluding reinfection.
From the end of treatment through 12 weeks after the last dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

November 11, 2015

First Submitted That Met QC Criteria

November 11, 2015

First Posted (Estimate)

November 13, 2015

Study Record Updates

Last Update Posted (Actual)

July 13, 2021

Last Update Submitted That Met QC Criteria

July 9, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M13-590
  • 2015-002087-17 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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