Study to Evaluate Adverse Events and Change in Disease Activity in Adult and Adolescent Participants With Acute Hepatitis C Virus (HCV) Infection on Treatment With Oral Tablets of Glecaprevir (GLE)/Pibrentasvir (PIB)

Part of paid clinical trials in Chandler, Arizona.

Sponsor
AbbVie
Study ID
NCT04903626
Phase
PHASE3
Status
Completed

Conditions

  • Hepatitis C Virus (HCV)

Eligibility Criteria

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

Interventions

Study Details

HCV infection is a global health problem. HCV mainly affects liver cells and causes the liver to become inflamed and damaged. This study will evaluate how safe and effective glecaprevir/pibrentasvir (GLE/PIB) is in adult and adolescent participants with acute HCV infection. GLE/PIB is an approved drug for the treatment of chronic HCV. Around 283 participants at least 12 years of age with acute HCV Infection will be enrolled in approximately 70 sites worldwide. Participants will receive oral tablets of GLE/PIB once daily (QD) for 8 weeks and will be followed for 12 weeks after the end of treatment. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, monitoring for side effects and completing questionnaires.

Key Dates

Start date
Aug 24, 2021
Status verified
Mar 2025
Primary completion
Sep 17, 2024
Completion
Sep 17, 2024

Study Design

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

Arms

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

Primary Outcome Measure

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

Locations (37)

FacilityCityStateZIPSite coordinators
Arizona Health Research /ID# 233558ChandlerArizona85225-2906-
The Institute for Liver Health /ID# 228427PeoriaArizona85381-
Liver Wellness Center /ID# 244933Little RockArkansas72204-
AHF Research Center /ID# 254795Beverly HillsCalifornia90211-
Velocity Clinical Research Chula Vista /ID# 238352Chula VistaCalifornia91911-6658-
AHF Healthcare Center- Hollywood /ID# 254794Los AngelesCalifornia90027-
TLC Clinical Research Inc /ID# 232334Los AngelesCalifornia90048-
University of California, Davis Comprehensive Cancer Center /ID# 230814SacramentoCalifornia95817-
Angels Clinical Research Institute /ID# 234090DoralFlorida33122-1713-
AIDS Healthcare Foundation (AHF) - Healthcare Center - Northpoint /ID# 254814Fort LauderdaleFlorida33308-
Midway Immunology and Research Center /ID# 229194Ft. PierceFlorida34982-
Midland Research Group, Inc /ID# 231885Oakland ParkFlorida33334-4434-
Orlando Immunology Center /ID# 229839OrlandoFlorida32803-
Tampa General Hospital /ID# 228930TampaFlorida33606-
Duplicate_Triple O Research Institute /ID# 229928West Palm BeachFlorida33407-3100-
Florida Medical Clinic /ID# 233489ZephyrhillsFlorida33542-
Emory Midtown Infectious Disease Clinic /ID# 229927AtlantaGeorgia30322-
University of Iowa Hospitals and Clinics /ID# 226934Iowa CityIowa52242-
Duplicate_University of Kentucky Chandler Medical Center /ID# 231588LexingtonKentucky40536-
University of Louisville Hospital /ID# 232139LouisvilleKentucky40202-
Johns Hopkins Hospital /ID# 230694BaltimoreMaryland21287-
Mercy Medical Center /ID# 226937BaltimoreMaryland21202-
Henry Ford Hospital /ID# 226932DetroitMichigan48202-
University of Mississippi Medical Center /ID# 232620JacksonMississippi39216-4500-
Las Vegas Research Center /ID# 255631Las VegasNevada89106-
North Jersey Community Research Initiative (NJCRI) /ID# 245129NewarkNew Jersey07103-2842-
Weill Cornell Medical College /ID# 230815New YorkNew York10065-
Coastal Research Institute, LLC /ID# 233233FayettevilleNorth Carolina28304-
Duplicate_University Of Cincinnati Medical Center /ID# 226922CincinnatiOhio45267-0585-
The Christ Hospital /ID# 231204CincinnatiOhio45219-
Cherokee Nation Outpatient Health Center /ID# 232618TahlequahOklahoma74464-0545-
Thomas Jefferson University Hospital /ID# 232624PhiladelphiaPennsylvania19107-
University Gastroenterology /ID# 233332ProvidenceRhode Island02905-
Vanderbilt University Medical Center /ID# 241282NashvilleTennessee37232-0011-
Liver Associates of Texas, P.A /ID# 229775HoustonTexas77030-2783-
Digestive and Liver Disease Sp /ID# 232633NorfolkVirginia23502-
Wisconsin Medical Center /ID# 230116MilwaukeeWisconsin53226-

Find similar trials in Chandler, AZ

By research site
Arizona Health Research· Chandler, AZThe Institute for Liver Health· Peoria, AZLiver Wellness Center· Little Rock, ARAHF Research Center· Beverly Hills, CAVelocity Clinical Research Chula Vista· Chula Vista, CAAHF Healthcare Center- Hollywood· Los Angeles, CA

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