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

Part of paid clinical trials in San Diego, California.

Sponsor
AbbVie
Study ID
NCT02966795
Phase
PHASE3
Status
Completed

Conditions

  • Hepatitis C Virus (HCV)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jan 25, 2017
Status verified
Jul 2021
Primary completion
Jun 6, 2018
Completion
Aug 29, 2018

Study Design

Enrollment
84 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Glecaprevir/Pibrentasvir for 8 Weeks
    Non-cirrhotic participants with hepatitis C virus genotype 5 or 6 received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for 8 weeks, according to label.
  • Experimental: Glecaprevir/Pibrentasvir for 12 Weeks
    Participants with hepatitis C virus genotype 5 or 6 and compensated cirrhosis received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for 12 weeks, according to label.

Primary Outcome Measure

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) ]

Locations (6)

FacilityCityStateZIPSite coordinators
Kaiser Permanente /ID# 157044San DiegoCalifornia92154-
Research & Education, Inc. /ID# 157042San DiegoCalifornia92105-
Zuckerberg San Francisco Gener /ID# 157040San FranciscoCalifornia94110-
Cedars-Sinai Medical Center - West Hollywood /ID# 157045West HollywoodCalifornia90048-
Einstein Medical Center /ID# 157436PhiladelphiaPennsylvania19141-
University of Washington /ID# 157041SeattleWashington98109-

Find similar trials in San Diego, CA

By research site
Kaiser Permanente· San Diego, CAResearch & Education, Inc.· San Diego, CAZuckerberg San Francisco Gener· San Francisco, CACedars-Sinai Medical Center - West Hollywood· West Hollywood, CAEinstein Medical Center· Philadelphia, PAUniversity of Washington· Seattle, WA

Related Studies