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
NCT ID: NCT03212521
Last Updated: 2019-09-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
230 participants
INTERVENTIONAL
2017-08-07
2018-08-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Glecaprevir/Pibrentasvir
Participants received oral glecaprevir/pibrentasvir (300 mg/120 mg) once daily with food for 8 weeks.
Glecaprevir/Pibrentasvir
Glecaprevir/pibrentasvir 100 mg/40 mg co-formulated tablets taken orally as 3 tablets once a day.
Interventions
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Glecaprevir/Pibrentasvir
Glecaprevir/pibrentasvir 100 mg/40 mg co-formulated tablets taken orally as 3 tablets once a day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aspartate aminotransferase (AST) to platelet ratio index (APRI) score of less than or equal to 1, at time of screening.
* Does not have current active hepatitis B virus infection defined as:
* positive hepatitis B surface antigen (HBsAg), OR
* hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \> lower limit of quantification (LLOQ) in subjects with isolated positive anti-hepatitis B core (HBc) (i.e., negative HBsAg and anti-hepatitis B surface\[HBs\])
* Platelets ≥ 150,000 cells/mm³
* Albumin ≥ lower limit of normal (LLN)
* Positive anti-HCV antibody (Ab) AND plasma HCV ribonucleic acid (RNA) viral load ≥ 1,000 IU/mL at Screening and for at least 6 months before Screening.
* No past history/evidence of cirrhosis.
* No history of hepatocellular carcinoma.
* Hepatitis C virus treatment-naïve (had not received a single dose of any approved or investigational anti-HCV medication).
* If female, the subject must not be pregnant, breastfeeding, or considering becoming pregnant during the study and for 30 days after the last dose of study drug.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Parkway Medical Center /ID# 161261
Birmingham, Alabama, United States
Arkansas Gastroenterology /ID# 161266
North Little Rock, Arkansas, United States
UC Davis Medical Center /ID# 161138
Sacramento, California, United States
Yale University /ID# 161258
New Haven, Connecticut, United States
Univ Maryland School Medicine /ID# 161157
Baltimore, Maryland, United States
Digestive Disease Associates - Baltimore /ID# 161260
Baltimore, Maryland, United States
University of Michigan Hospitals /ID# 161265
Ann Arbor, Michigan, United States
Northwest Gastroenterology Cli /ID# 161257
Portland, Oregon, United States
Liver Associates of Texas, P.A /ID# 161262
Houston, Texas, United States
University of Vermont Medical Center /ID# 161263
Burlington, Vermont, United States
Digestive and Liver Disease Sp /ID# 161259
Norfolk, Virginia, United States
DCC Aleksandrovska /ID# 161340
София, Sofia, Bulgaria
DCC Mladost M /ID# 161339
Varna, , Bulgaria
South Health Campus /ID# 161385
Calgary, Alberta, Canada
The Moncton Hospital /ID# 161384
Moncton, New Brunswick, Canada
Brampton Civic Hospital /ID# 161380
Brampton, Ontario, Canada
Toronto Liver Centre /ID# 161381
Toronto, Ontario, Canada
Hopital Saint Joseph /ID# 161571
Marseille, Bouches-du-Rhone, France
CHU de Rennes - PONTCHAILLOU /ID# 161492
Rennes, Brittany Region, France
CHU de Besancon - Jean Minjoz /ID# 161485
Besançon, Doubs, France
Hopitaux de Brabois Adultes /ID# 161482
Vandœuvre-lès-Nancy, Lorraine, France
Universitätsklinikum Frankfurt /ID# 161397
Frankfurt am Main, Hesse, Germany
Universitaetsmedizin der Johannes-Gutenberg Universität Mainz /ID# 161396
Mainz, Rhineland-Palatinate, Germany
Charité Universitätsmedizin Campus Mitte /ID# 161395
Berlin, , Germany
ICH Study Center GmbH & Co KG /ID# 161394
Hamburg, , Germany
Centrum Badan Klinicznych /Id# 162218
Wroclaw, Lower Silesian Voivodeship, Poland
HepID - Diagnostyka I Terapia /ID# 162219
Lublin, Lublin Voivodeship, Poland
Uniwersytecki Szpital Kliniczn /ID# 162216
Bialystok, , Poland
ID Clinic /ID# 162217
Mysłowice, , Poland
Innovative Care P.S.C. /ID# 162787
San Juan, , Puerto Rico
A. F. Agafonov Republican Clin /ID# 163164
Kazan', Tatarstan, Respublika, Russia
South Ural State Medical univ /ID# 163163
Chelyabinsk, , Russia
A.I. Evdokimov Moscow State Un /ID# 163162
Moscow, , Russia
Hospital Fundacion Alcorcon /ID# 161436
Alcorcón, , Spain
Hospital Clinic de Barcelona /ID# 161437
Barcelona, , Spain
Hospital Vall d'Hebron /ID# 162022
Barcelona, , Spain
Hosp Uni Virgen de la Victoria /ID# 164383
Málaga, , Spain
Complexo Hospitalario universi /ID# 165603
Pontevedra, , Spain
Bradford Teaching Hospitals /ID# 161424
Bradford, , United Kingdom
Glasgow Royal Infirmary /ID# 161458
Glasgow, , United Kingdom
Gloucester Royal Hospital /ID# 161423
Gloucester, , United Kingdom
Freeman Hospital /ID# 161459
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Fontana RJ, Lens S, McPherson S, Elkhashab M, Ankoma-Sey V, Bondin M, Dos Santos AGP, Xue Z, Trinh R, Porcalla A, Zeuzem S. Efficacy and Safety of 8 Weeks of Glecaprevir/Pibrentasvir in Treatment-Naive, HCV-Infected Patients with APRI </= 1 in a Single-Arm, Open-Label, Multicenter Study. Adv Ther. 2019 Dec;36(12):3458-3470. doi: 10.1007/s12325-019-01123-0. Epub 2019 Oct 23.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-004876-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M16-133
Identifier Type: -
Identifier Source: org_study_id
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