Clinical trial NCT03212521: 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
Official title: A Single Arm, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults With Chronic Hepatitis C Virus (HCV) Genotypes 1 - 6 Infection and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤ 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C Virus (HCV)
Keywords: chronic hepatitis C virus (HCV)
Hepatitis
HCV genotype
aspartate aminotransferase
platelet
Aspartate aminotransferase to Platelet Ratio Index (APRI)
glecaprevir
pibrentasvir
Sustained Virologic Response 12 weeks post dosing (SVR12)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-07-11
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5, or 6 infection. Mixed GT and indeterminate GT may be acceptable.
* 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.

Primary outcomes:
measure: Percentage of Participants in the Modified Intention-to-Treat Population With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
timeFrame: 12 weeks after the last actual dose of study drug, Week 20
Secondary outcomes:
measure: Percentage of Participants in the Intention-to-Treat Population With SVR12
timeFrame: 12 weeks after the last actual dose of study drug, Week 20
measure: Percentage of Participants With On-treatment Virologic Failure
timeFrame: Up to 8 weeks
measure: Percentage of Participants With Post-treatment Relapse
timeFrame: From the end of treatment (Week 8) through 12 weeks after the last dose of study drug (Week 20)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Parkway Medical Center /ID# 161261
state: Alabama
city: North Little Rock
country: United States
facility: Arkansas Gastroenterology /ID# 161266
state: Arkansas
city: Sacramento
country: United States
facility: UC Davis Medical Center /ID# 161138
state: California
city: New Haven
country: United States
facility: Yale University /ID# 161258
state: Connecticut
city: Baltimore
country: United States
facility: Univ Maryland School Medicine /ID# 161157
state: Maryland
city: Baltimore
country: United States
facility: Digestive Disease Associates - Baltimore /ID# 161260
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Hospitals /ID# 161265
state: Michigan
city: Portland
country: United States
facility: Northwest Gastroenterology Cli /ID# 161257
state: Oregon
city: Houston
country: United States
facility: Liver Associates of Texas, P.A /ID# 161262
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Center /ID# 161263
state: Vermont
city: Norfolk
country: United States
facility: Digestive and Liver Disease Sp /ID# 161259
state: Virginia
city: София
country: Bulgaria
facility: DCC Aleksandrovska /ID# 161340
state: Sofia
city: Varna
country: Bulgaria
facility: DCC Mladost M /ID# 161339
city: Calgary
country: Canada
facility: South Health Campus /ID# 161385
state: Alberta
city: Moncton
country: Canada
facility: The Moncton Hospital /ID# 161384
state: New Brunswick
city: Brampton
country: Canada
facility: Brampton Civic Hospital /ID# 161380
state: Ontario
city: Toronto
country: Canada
facility: Toronto Liver Centre /ID# 161381
state: Ontario
city: Marseille CEDEX 08
country: France
facility: Hopital Saint Joseph /ID# 161571
state: Bouches-du-Rhone
city: Rennes
country: France
facility: CHU de Rennes - PONTCHAILLOU /ID# 161492
state: Bretagne
city: Besancon
country: France
facility: CHU de Besancon - Jean Minjoz /ID# 161485
state: Doubs
city: Vandoeuvre les Nancy
country: France
facility: Hopitaux de Brabois Adultes /ID# 161482
state: Lorraine
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt /ID# 161397
state: Hessen
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes-Gutenberg Universität Mainz /ID# 161396
state: Rheinland-Pfalz
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Campus Mitte /ID# 161395
city: Hamburg
country: Germany
facility: ICH Study Center GmbH & Co KG /ID# 161394
city: Wrocław
country: Poland
facility: Centrum Badan Klinicznych /Id# 162218
state: Dolnoslaskie
city: Lublin
country: Poland
facility: HepID - Diagnostyka I Terapia /ID# 162219
state: Lubelskie
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczn /ID# 162216
city: Myslowice
country: Poland
facility: ID Clinic /ID# 162217
city: San Juan
country: Puerto Rico
facility: Innovative Care P.S.C. /ID# 162787
city: Kazan
country: Russian Federation
facility: A. F. Agafonov Republican Clin /ID# 163164
state: Tatarstan, Respublika
city: Chelyabinsk
country: Russian Federation
facility: South Ural State Medical univ /ID# 163163
city: Moscow
country: Russian Federation
facility: A.I. Evdokimov Moscow State Un /ID# 163162
city: Alcorcon
country: Spain
facility: Hospital Fundacion Alcorcon /ID# 161436
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona /ID# 161437
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron /ID# 162022
city: Malaga
country: Spain
facility: Hosp Uni Virgen de la Victoria /ID# 164383
city: Pontevedra
country: Spain
facility: Complexo Hospitalario universi /ID# 165603
city: Bradford
country: United Kingdom
facility: Bradford Teaching Hospitals /ID# 161424
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary /ID# 161458
city: Gloucester
country: United Kingdom
facility: Gloucester Royal Hospital /ID# 161423
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital /ID# 161459
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: 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.