A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
AbbVie
Study ID
NCT03089944
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, single arm, open-label, multicenter study in treatment naïve adults with chronic HCV infection and compensated cirrhosis to assess the safety of 8 weeks of treatment with glecaprevir/pibrentasvir and to demonstrate the efficacy of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of treatment with glecaprevir/pibrentasvir compared to the historical SVR12 rates of 12 weeks of treatment with glecaprevir/pibrentasvir.

Key Dates

Start date
Apr 28, 2017
Status verified
Jun 2020
Primary completion
Jul 31, 2019
Completion
Nov 8, 2019

Study Design

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

Arms

  • Experimental: Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 weeks
    Glecaprevir (GLE)/Pibrentasvir (PIB) 300 mg/120 mg once daily (QD) for 8 weeks.

Primary Outcome Measure

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Hepatitis C Virus (HCV) Genotype (GT) 1,2,4,5 and 6-infected Participants in the Per Protocol (PP) Population [ Time Frame: 12 weeks after last dose of study drug ]

Locations (40)

FacilityCityStateZIPSite coordinators
Mayo Clinic Arizona /ID# 162314PhoenixArizona85054-
St. Josephs Hosp and Med Ctr /ID# 162762PhoenixArizona85013-
Liver Wellness Center /ID# 162244Little RockArkansas72204-
Felizarta /ID# 162295BakersfieldCalifornia93301-
VA Long Beach Healthcare System /ID# 162298Long BeachCalifornia90822-
Usc /Id# 162248Los AngelesCalifornia90033-
Kaiser Permanente - San Diego (Palm Ave) /ID# 162289San DiegoCalifornia92154-
Stanford University School of Med /ID# 162209StanfordCalifornia94305-2200-
Cedars-Sinai Medical Center - West Hollywood /ID# 162313West HollywoodCalifornia90048-
University of Miami /ID# 162210MiamiFlorida33136-
Triple O Research Institute /ID# 162300West Palm BeachFlorida33407-3100-
Piedmont Hospital /ID# 162646AtlantaGeorgia30309-
Northwestern University Feinberg School of Medicine /ID# 162208ChicagoIllinois60611-2927-
Unity Point Health /ID# 162247Des MoinesIowa50309-
The University of Iowa Hospita /ID# 162214Iowa CityIowa52242-
University of Louisville /ID# 162242LouisvilleKentucky40202-
Louisiana Research Ctr. LLC /ID# 162567ShreveportLouisiana71105-6800-
Mercy Medical Center /ID# 162291BaltimoreMaryland21202-
Mayo Clinic - Rochester /ID# 162251RochesterMinnesota55905-0001-
Southern Therapy and Advanced Research (STAR) LLC /ID# 162241JacksonMississippi39216-
CHI Health Alegent Creighton /ID# 162286OmahaNebraska68124-
Univ Nebraska Med Ctr /ID# 162285OmahaNebraska68198-
Rnjms /Id# 162213NewarkNew Jersey07103-
Icahn School of Med Mt. Sinai /ID# 162294New YorkNew York10029-
Weill Cornell Medical College /ID# 161051New YorkNew York10021-
James J. Peters VA Medical Center /ID# 162644The BronxNew York10468-
Montefiore Medical Center /ID# 162312The BronxNew York10461-
Duke University Medical Center /ID# 162299DurhamNorth Carolina27710-3000-
Cumberland Research Assoc /ID# 162212FayettevilleNorth Carolina28304-
Carolinas Center for Liver Dis /ID# 162569StatesvilleNorth Carolina28677-3471-
Cleveland Clinic /ID# 162570ClevelandOhio44111-
University Hospitals Cleveland /ID# 162243ClevelandOhio44106-
Osuchs /Id# 162284TulsaOklahoma74127-
Lehigh Valley Health Network /ID# 162603AllentownPennsylvania18103-
Center for Liver Diseases, Oakland /ID# 162568PittsburghPennsylvania15213-
Vanderbilt Univ Med Ctr /ID# 162211NashvilleTennessee37232-0011-
Texas Digestive Disease Consul /ID# 162648DallasTexas75246-1613-
University of Texas Health /ID# 162288HoustonTexas77030-1501-
Virginia Commonwealth Univ /ID# 162215RichmondVirginia23219-
Univ of Wisconsin Hosp/Clinics /ID# 162645MadisonWisconsin53792-0001-

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic Arizona· Phoenix, AZSt. Josephs Hosp and Med Ctr· Phoenix, AZLiver Wellness Center· Little Rock, ARFelizarta· Bakersfield, CAVA Long Beach Healthcare System· Long Beach, CAUsc· Los Angeles, CA

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