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Clinical Trials

MainTitle

A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With or Without Human Immunodeficiency Virus Co-Infection

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified July 2017 by AbbVie

Sponsor
AbbVie


Information provided by (Responsible Party)
AbbVie
ClinicalTrials.gov Identifier
NCT03222583

First received: July 17, 2017
Last updated: July 19, 2017
Last Verified: July 2017
History of Changes
Purpose

Purpose

A Phase 3, double-blind (DB), placebo-controlled study to evaluate the efficacy and safety of ABT-493/ABT-530 in non-cirrhotic chronic hepatitis C virus (HCV) genotype (GT)1 to GT6-infected Asian participants with or without human immunodeficiency virus (HIV) co-infection who are HCV treatment-naïve or treatment-experienced with interferon (IFN) (alpha, beta or pegylated interferon [pegIFN]) with or without ribavirin (RBV) OR sofosbuvir with RBV with or without IFN.

Condition Intervention Phase
Hepatitis C Virus (HCV)

Drug : ABT-493/ABT-530
Drug : Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With or Without Human Immunodeficiency Virus Co-Infection

Further study details as provided by AbbVie:

Primary Outcome Measures

  • Percentage of Arm A HCV genotype (GT)1-6 Infected Participants Achieving SVR12 [ Time Frame: 12 weeks after the last actual dose of study drug ]
    Sustained Virologic Response 12 Weeks Post-treatment (SVR12) was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [
  • Percentage of Arm A HCV GT1-Infected Participants Achieving SVR12 [ Time Frame: 12 weeks after last does of study drug ]
    SVR12 was defined as plasma HCV RNA level less than LLOQ 12 weeks after the last dose of study drug.
  • Percentage of Arm A HCV GT2-Infected Participants Achieving SVR12 [ Time Frame: 12 weeks after the last dose of study drug ]
    SVR12 was defined as plasma HCV RNA level less than the LLOQ 12 weeks after the last actual dose of study drug
Secondary Outcome Measures:
  • Percentage of Participants in Arm A With On-treatment Virologic Failure [ Time Frame: Up to 8-16 weeks while on treatment ]
    On-treatment virologic failure was defined as confirmed increase of > 1 log10 IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA greater than or equal to 100 IU/mL after HCV RNA < LLOQ during treatment, or with quantifiable HCV RNA at end of treatment with at least 6 weeks of treatment.
  • Percentage of Participants in Arm A 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 greater than or equal to the 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.
  • Percentage of HCV/HIV Co-infected Participants in Arm A Achieving SVR12 [ Time Frame: 12 weeks after the last actual dose of study drug ]
    SVR12 was defined as plasma HCV RNA level less than LLOQ 12 weeks after the last dose of study drug.

Estimated Enrollment: 504
Study Start Date: August 29, 2017
Estimated Study Completion Date: June 7, 2019
Estimated Primary Completion Date: December 7, 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Arm A DB Active Drug
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 or 16 weeks (double-blind [DB] treatment period)
Drug: ABT-493/ABT-530

Tablet; ABT-493 coformulated with ABT-530

Other Name:
  • ABT-493 also known as glecaprevir
  • ABT-530 also known as pibrentasvir

Experimental: Arm B DB Placebo then OL Active Drug
Placebo for ABT-493/ABT-530 QD for 8 or 16 weeks (DB treatment period) followed by ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 or 16 weeks (open-label [OL] treatment period)
Drug: ABT-493/ABT-530

Tablet; ABT-493 coformulated with ABT-530

Other Name:
  • ABT-493 also known as glecaprevir
  • ABT-530 also known as pibrentasvir

Drug: Placebo

Tablet; matching placebo

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 99 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  • Must be of Asian descent
  • Screening laboratory result indicating Hepatitis C Virus (HCV) Genotype (GT) 1, 2, 3, 4, 5 or 6 infection.
  • Positive anti-HCV antibody (Ab) and HCV Ribonucleic acid (RNA) greater than or equal to 1000 IU/ mL at Screening Visit.
  • Chronic HCV infection defined as one of the following:
  • Positive for anti-HCV Ab or HCV RNA at least 6 months before Screening; or
  • A liver biopsy consistent with chronic HCV infection
  • HCV treatment-naïve to any approved or investigational HCV treatment or treatment-experienced with interferon (IFN) (alpha, beta or pegylated interferon[pegIFN] with or without ribavirin OR sofosbuvir with RBV with or without IFN. Previous treatment must have been completed >= 8 weeks prior to screening.
  • Participant must be documented as non-cirrhotic.
  • Participants enrolled with human immunodeficiency virus (HIV)-1 and HCV co-infection must also meet the following criteria:
  • Positive test result for Human Immunodeficiency Virus antibody (HIV Ab) at Screening
  • Naïve to treatment with any antiretroviral therapy (ART) with a CD4+ count greater than or equal to 500 cells/mm3 (or CD4+ % >= 29%)
  • On a stable, qualifying HIV-1 ART regimen with plasma HIV-1 RNA below lower limit of quantification (LLOQ) by an approved plasma HIV-1 RNA quantitative assay at Screening and at least once during the 12 months prior to Screening.


Exclusion Criteria:
  • Positive test result for Hepatitis B surface antigen (HbsAg) or positive test result for hepatitis B virus (HBV) deoxyribonucleic acid (DNA) if HBsAg is negative.
  • Any cause of liver disease other than chronic HCV-infection.
  • HCV genotype performed during screening indicating co-infection with more than one HCV genotype
  • Clinically significant abnormalities, other than HCV infection or HCV/HIV co-infection
  • Chronic human immunodeficiency virus, type 2 (HIV-2) infection

  • Additional Exclusion Criteria for participants with HCV/HIV Co-Infection:
  • For participants on stable ART, taking anti-retroviral agent(s) other than those permitted
  • Treatment for an AIDS-associated opportunistic infection within 12 months of Screening or prophylaxis for an AIDS-associated opportunistic infection within 6 months of screening
  • Diagnosis of any clinical AIDS-defining event within 12 months prior to Screening.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03222583

Contacts

Contact:   AbbVie_Call Center 847.283.8955 abbvieclinicaltrials@abbvie.com

Sponsors and Collaborators

AbbVie

Investigators

Study Director: AbbVie Inc AbbVie
More Information

More Information


Responsible Party: AbbVie  
ClinicalTrials.gov Identifier: NCT03222583   History of Changes  
Other Study ID Numbers: M15-592  
Study First Received: July 17, 2017  
Last Updated: July 19, 2017  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by AbbVie:

Treatment-naïve
co-infection
Chronic Hepatitis C Virus (HCV)
non-cirrhotic
Asian
Human Immunodeficiency Virus
Genotype 1 to 6
interferon
Treatment-experienced

Additional relevant MeSH terms:
Infection
Hepatitis
Hepatitis A
Virus Diseases
Hepatitis C
Hepatitis, Chronic
Immunologic Deficiency Syndromes
Hepatitis C, Chronic
Acquired Immunodeficiency Syndrome
HIV Infections
Coinfection

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.