Efficacy and Safety of 8-weeks of Glecaprevir/Pibrentasvir in Treatment-Naïve Adults With HCV Genotype 1-6 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤1

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AbbVie
Study ID
NCT03212521
Phase
PHASE3
Status
Completed

Conditions

  • Hepatitis C Virus (HCV)

Eligibility Criteria

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

Interventions

  • Glecaprevir/Pibrentasvir — DRUG
    Glecaprevir/pibrentasvir 100 mg/40 mg co-formulated tablets taken orally as 3 tablets once a day.

Study Details

A study to evaluate the efficacy and safety of glecaprevir(GLE)/pibrentasvir(PIB) in treatment-naïve participants with chronic hepatitis C virus (HCV) genotypes 1-6 infection and with an aspartate aminotransferase to platelet ratio index (APRI) of less than or equal to 1.

Key Dates

Start date
Aug 7, 2017
Status verified
Aug 2018
Primary completion
Aug 13, 2018
Completion
Aug 13, 2018

Study Design

Enrollment
230 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Glecaprevir/Pibrentasvir
    Participants received oral glecaprevir/pibrentasvir (300 mg/120 mg) once daily with food for 8 weeks.

Primary Outcome Measure

Percentage of Participants in the Modified Intention-to-Treat Population With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [ Time Frame: 12 weeks after the last actual dose of study drug, Week 20 ]

Locations (11)

FacilityCityStateZIPSite coordinators
Parkway Medical Center /ID# 161261BirminghamAlabama35215-
Arkansas Gastroenterology /ID# 161266North Little RockArkansas72117-
UC Davis Medical Center /ID# 161138SacramentoCalifornia95817-
Yale University /ID# 161258New HavenConnecticut06510-
Digestive Disease Associates - Baltimore /ID# 161260BaltimoreMaryland21229-
Univ Maryland School Medicine /ID# 161157BaltimoreMaryland21201-
University of Michigan Hospitals /ID# 161265Ann ArborMichigan48109-5008-
Northwest Gastroenterology Cli /ID# 161257PortlandOregon97210-
Liver Associates of Texas, P.A /ID# 161262HoustonTexas77030-2783-
University of Vermont Medical Center /ID# 161263BurlingtonVermont05401-1473-
Digestive and Liver Disease Sp /ID# 161259NorfolkVirginia23502-

Find similar trials in Birmingham, AL

By research site
Parkway Medical Center· Birmingham, ALArkansas Gastroenterology· North Little Rock, ARUC Davis Medical Center· Sacramento, CAYale University· New Haven, CTDigestive Disease Associates - Baltimore· Baltimore, MDUniv Maryland School Medicine· Baltimore, MD

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