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Completed

NCT Number: NCT02966795

A Study of of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection

A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir for an 8- or 12-week treatment duration in participants with chronic hepatitis C virus (HCV) genotype (GT) 5 or 6 infection, with or without compensated cirrhosis respectively.

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Key information

Conditions

Hepatitis C Virus (HCV) Blood-Borne Infections Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Communicable Diseases Digestive System Diseases Flaviviridae Infections Graft vs Host Disease Hepatitis Hepatitis C Hepatitis, Viral, Human Immune System Diseases Infections Liver Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia RNA Virus Infections Respiratory Tract Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nepean Hospital Kingswood /ID# 157027, Kingswood, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Screening laboratory result indicating hepatitis C virus (HCV) GT5 or 6 infection.
  • Participant has a positive anti-HCV antibody (Ab) and plasma HCV ribonucleic acid (RNA) greater than or equal to 1000 IU/mL at Screening Visit.
  • Participant must be HCV treatment-naïve (i.e., has never received a single dose of any approved or investigational anti-HCV medication) or treatment-experienced (i.e., has failed prior interferon [IFN] or pegylated interferon [pegIFN] with or without ribavirin [RBV], or sofosbuvir [SOF] plus RBV with or without pegIFN therapy). Prior HCV treatment with any other approved or investigational medications is not allowed. Previous HCV treatment must have been completed greater than or equal to 2 months prior to screening.
  • Participant must be documented as having no cirrhosis or compensated cirrhosis.

Exclusion criteria

  • Female participant who is pregnant, breastfeeding, or is considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug.
  • 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.
  • History of severe, life-threatening or other significant sensitivity to any excipients of the study drug.

Treatment and study plan

Glecaprevir/Pibrentasvir

Drug

Fixed-dose combination tablets taken orally once a day.

Other names: ABT-493/ABT-530, MAVYRET™

Primary outcomes

  1. Percentage of Participants With Sustained Virologic Response 12 Weeks Post Treatment (SVR12)

    Time frame: 12 weeks after last dose of study drug (week 20 or 24 depending on the treatment regimen)

    SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; less than 15 IU/mL) 12 weeks after the last actual dose of study drug.

Secondary outcomes

  1. Percentage of Participants With On-treatment HCV Virologic Failure

    Time frame: 8 or 12 weeks (depending on the treatment regimen)

    HCV virologic failure was defined as one of the following conditions:

    • confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < 15 IU/mL during the Treatment Period; or confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log10 IU/mL above nadir) at any time point during the Treatment Period; or
    • HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment, where the HCV RNA value must be collected on or after Study Drug Day 36 and study drug duration ≥ 36 days.

  2. Percentage of Participants With Relapse

    Time frame: End of treatment (week 8 or 12 depending on the treatment regimen) through 12 weeks after the end of treatment.

    Relapse was defined as confirmed HCV RNA ≥ 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment as planned with HCV RNA < 15 IU/mL at the end of treatment and had post-treatment HCV RNA data; participants who had been shown to be re-infected were not considered to have relapsed.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection

Acronym: ENDURANCE-5 6

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 17, 2016
Registry last updated
Jul 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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