A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With HCV Genotype 1, 4, 5, and 6 Infection

July 9, 2021 updated by: AbbVie

An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With Chronic Hepatitis C Virus (HCV) Genotype 1, 4, 5, and 6 Infection (SURVEYOR-I)

The purpose of this Phase 2, open-label, 2-part, multicenter study was to evaluate the efficacy, safety, and pharmacokinetics of co-administration of ABT-493 and ABT-530 with and without ribavirin (RBV) at different doses in chronic Hepatitis C virus (HCV) Genotype 1 (GT1), Genotype 4 (GT4), Genotype 5 (GT5), and Genotype 6 (GT6) infection with compensated cirrhosis (GT1 only) or without cirrhosis (GT1, GT4, GT5, or GT6). Although RBV was initially planned in the protocol, it was not administered in any of the study arms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study consisted of two independent parts: Part 1 was conducted first followed by Part 2. Part 1 enrolled participants who received ABT-493 and ABT-530 for 12 weeks; Part 2 enrolled participants who received ABT-493 and ABT-530 for 8 or 12 weeks. Participants who completed or prematurely discontinued the treatment period were followed for 24 weeks to monitor HCV RNA to evaluate efficacy and the emergence and persistence of viral variants.

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Phase 2

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 to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female between 18 and 70 years of age, inclusive, at time of screening
  2. Screening laboratory result indicating hepatitis C virus (HCV) GT1 (Study Parts 1 and 2) or GT4, GT5, or GT6 (Study Part 2) infection

  3. Chronic HCV infection defined as one of the following:

    • Positive for anti-HCV antibody (Ab) or HCV RNA at least 6 months before screening, and positive for HCV RNA and anti-HCV Ab at the time of screening or
    • Positive for anti-HCV Ab and HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed prior to enrollment with evidence of chronic HCV infection)

  4. Participant had to meet one of the following criteria:

    • Treatment-naïve: participant had never received treatment for HCV infection
    • Treatment-experienced: pegylated-interferon alpha-2a or alpha-2b and ribavirin (PR)-null responder (for Study Part 1) or PR-experienced (on-treatment failure or prior relapse) (for Study Part 2)
  5. Documented absence of cirrhosis (in Study Part 1 and in corresponding arms of Study Part 2), or compensated cirrhosis (in corresponding arms of Study Part 2, GT1 only), per local standard

Exclusion Criteria:

  1. History of severe, life-threatening or other significant sensitivity to any drug
  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) or anti-human immunodeficiency virus antibody (HIV Ab)
  5. Hepatitis C virus (HCV) genotype performed during screening indicating co-infection with more than one HCV genotype
  6. Any cause of liver disease other than chronic HCV infection
  7. Participants with plasma HCV RNA load ≤ 10,000 international units (IU)/mL or unquantifiable or undetectable HCV RNA at screening
  8. Previous use of an HCV direct-acting antiviral agent (DAA)
  9. Consideration by the investigator, for any reason, that the participant was an unsuitable candidate to receive ABT-493, ABT-530, or RBV (RBV for cirrhotic subjects only)
  10. For participants in Study Part 2 who were enrolling with compensated cirrhosis: past clinical evidence of Child-Pugh B or C Classification (score of > 6) or clinical history of liver decompensation, including ascites (noted on physical exam), bleeding varices, use of beta-blockers for portal hypertension or ascites, or hepatic encephalopathy

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: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
Drug: ABT-493
Tablet
Other Names:
  • glecaprevir
Drug: ABT-530
Tablet
Other Names:
  • pibrentasvir
Experimental: Arm B
ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis
Drug: ABT-493
Tablet
Other Names:
  • glecaprevir
Drug: ABT-530
Tablet
Other Names:
  • pibrentasvir
Experimental: Arm C
ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)
Drug: ABT-493
Tablet
Other Names:
  • glecaprevir
Drug: ABT-530
Tablet
Other Names:
  • pibrentasvir
Experimental: Arm D
ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)
Drug: ABT-493
Tablet
Other Names:
  • glecaprevir
Drug: ABT-530
Tablet
Other Names:
  • pibrentasvir
Experimental: Arm E
ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)
Drug: ABT-493
Tablet
Other Names:
  • glecaprevir
Drug: ABT-530
Tablet
Other Names:
  • pibrentasvir
Experimental: Arm F
ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis
Drug: ABT-493
Tablet
Other Names:
  • glecaprevir
Drug: ABT-530
Tablet
Other Names:
  • pibrentasvir
Experimental: Arm G
ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)
Drug: ABT-493
Tablet
Other Names:
  • glecaprevir
Drug: ABT-530
Tablet
Other Names:
  • pibrentasvir
Experimental: Arm H
ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)
Drug: ABT-493
Tablet
Other Names:
  • glecaprevir
Drug: ABT-530
Tablet
Other Names:
  • pibrentasvir
Experimental: Arm I
ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis
Drug: ABT-493
Tablet
Other Names:
  • glecaprevir
Drug: ABT-530
Tablet
Other Names:
  • pibrentasvir
Experimental: Arm J
ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)
Drug: ABT-493
Tablet
Other Names:
  • glecaprevir
Drug: ABT-530
Tablet
Other Names:
  • pibrentasvir
Experimental: Arm K
ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
Drug: ABT-493
Tablet
Other Names:
  • glecaprevir
Drug: ABT-530
Tablet
Other Names:
  • pibrentasvir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks Post-treatment
Time Frame: 12 weeks after the last actual dose of study drug
The percentage of participants with sustained virologic response (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.
12 weeks after the last actual dose of study drug

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virologic Response (SVR) 4 Weeks Post-treatment
Time Frame: 4 weeks after the last actual dose of study drug
The percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid [HCV RNA] less than the lower limit of quantification [<LLOQ]) 4 weeks after the last dose of study drug.
4 weeks after the last actual dose of study drug
Percentage of Participants With On-treatment Virologic Failure
Time Frame: Screening, Day 1, Day 3, treatment weeks 1, 2, 4, 6, 8, 10, and 12 or premature discontinuation from treatment
The percentage of participants with on-treatment virologic failure (defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment), confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.
Screening, Day 1, Day 3, treatment weeks 1, 2, 4, 6, 8, 10, and 12 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 hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantitation (≥ 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.
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

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

August 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

September 4, 2014

First Submitted That Met QC Criteria

September 15, 2014

First Posted (Estimate)

September 17, 2014

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

  • M14-867
  • 2014-002925-36 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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