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Summary

for people ages 18–99 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir (ABT-493)/pibrentasvir (ABT-530) 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, who are either HCV treatment-naïve or treatment experienced with interferon (IFN) or pegylated interferon (pegIFN) with or without ribavirin (RBV) (defined as P/R treatment-experienced) or sofosbuvir (SOF) plus RBV with or without pegIFN (defined as SOF plus RBV treatment-experienced).

Official Title

M16-126 A Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection

Keywords

Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection sofosbuvir (SOF) ribavirin (RBV) pegylated interferon (pegIFN) interferon (IFN) pegylated-interferon (pegIFN) non-cirrhotic glecaprevir compensated cirrhosis pibrentasvir Sustained Virologic Response 12 weeks post dosing (SVR12) Infection Communicable Diseases Hepatitis Hepatitis A Hepatitis C Hepatitis, Chronic Hepatitis C, Chronic Interferons

Eligibility

You can join if…

Open to people ages 18–99

  • 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.

You CAN'T join if...

  • 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.

Locations

  • Zuckerberg San Francisco General Hospital and Trauma Center /ID# 157040 accepting new patients
    San Francisco, California, 94110, United States
  • Kaiser Permanente /ID# 157044 accepting new patients
    Los Angeles, California, 90027, United States
  • Cedars-Sinai Medical Center /ID# 157045 accepting new patients
    Los Angeles, California, 90048, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT02966795
Phase
Phase 3
Study Type
Interventional
Last Updated
November 29, 2017
I’m interested in this study!