Clinical trial NCT04903626: 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)
Official title: A Multicenter, Single-Arm Prospective Study to Evaluate Safety and Efficacy of GLE/PIB 8-Week Treatment in Adults and Adolescents With Acute Hepatitis C Virus (HCV) Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C Virus (HCV)
Keywords: Acute HCV Infection
HCV Genotype 1-6
Hepatitis C
Glecaprevir
Pibrentasvir
Mavyret
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-05-26
Enrollment: 286
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Evidence of acute HCV infection prior to enrollment, defined as a physician diagnosis of acute HCV infection, quantifiable HCV ribonucleic Acid (RNA) at screening, and at least 1 of the following:

  * Negative anti-HCV antibody, HCV RNA and/or HCV core antigen followed by a positive HCV RNA or HCV core antigen all within an 8-month period prior to screening; OR
  * Negative anti-HCV antibody, HCV RNA and/or HCV core antigen followed by a positive HCV RNA or HCV core antigen all within an 11-month period prior to screening; AND risk behavior for HCV infection within 6 months prior to positive HCV RNA or HCV core antigen; OR
  * Clinical signs and symptoms compatible with acute hepatitis \[alanine aminotransferase (ALT) \> 5 × upper limit of normal (ULN) and/or jaundice\] in the absence of a history of chronic liver disease or other cause of acute hepatitis and positive HCV RNA or HCV core antigen all within an 8-month period prior to screening; AND risk behavior for HCV infection within 6 months prior to positive HCV RNA or HCV core antigen; OR
  * Negative anti-HCV antibody with a positive HCV RNA or HCV core antigen within a 5-month period prior to screening.
* Absence of hepatocellular carcinoma (HCC), for participants with cirrhosis, or with indeterminate cirrhosis status, as indicated by a negative ultrasound, computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to screening or a negative ultrasound at screening. Participant who has a positive ultrasound result suspicious of HCC followed by a subsequent negative CT scan or MRI or biopsy result will be eligible for the study.
* Participants documented as having no cirrhosis or as having compensated cirrhosis.

Exclusion Criteria:

* Participants with prior treatment, including interferon for this HCV infection.
* History of liver decompensation.

Primary outcomes:
measure: Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in the Intention-to-Treat (ITT) Population
timeFrame: 12 weeks after last dose of study treatment (Week 20)
Secondary outcomes:
measure: Percentage of Participants Achieving SVR12 in the Modified ITT-Virologic Failure (mITT-VF) Population
timeFrame: 12 weeks after last dose of study treatment (Week 20)
measure: Percentage of Participants With On-Treatment Virologic Failure in the ITT Population
timeFrame: Up to Week 8
measure: Percentage of Participants With Post-Treatment (PT) Relapse in the ITT Population
timeFrame: Up to 12 weeks after the last dose of study treatment (Week 20)
measure: Percentage of Participants With PT Reinfection With HCV in the ITT Population
timeFrame: Up to 12 weeks after the last dose of study treatment (Week 20)
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Arizona Health Research /ID# 233558
state: Arizona
city: Peoria
country: United States
facility: The Institute for Liver Health /ID# 228427
state: Arizona
city: Little Rock
country: United States
facility: Liver Wellness Center /ID# 244933
state: Arkansas
city: Beverly Hills
country: United States
facility: AHF Research Center /ID# 254795
state: California
city: Chula Vista
country: United States
facility: Velocity Clinical Research Chula Vista /ID# 238352
state: California
city: Los Angeles
country: United States
facility: AHF Healthcare Center- Hollywood /ID# 254794
state: California
city: Los Angeles
country: United States
facility: TLC Clinical Research Inc /ID# 232334
state: California
city: Sacramento
country: United States
facility: University of California, Davis Comprehensive Cancer Center /ID# 230814
state: California
city: Doral
country: United States
facility: Angels Clinical Research Institute /ID# 234090
state: Florida
city: Fort Lauderdale
country: United States
facility: AIDS Healthcare Foundation (AHF) - Healthcare Center - Northpoint /ID# 254814
state: Florida
city: Fort Pierce
country: United States
facility: Midway Immunology and Research Center /ID# 229194
state: Florida
city: Oakland Park
country: United States
facility: Midland Research Group, Inc /ID# 231885
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center /ID# 229839
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital /ID# 228930
state: Florida
city: West Palm Beach
country: United States
facility: Duplicate_Triple O Research Institute /ID# 229928
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic /ID# 233489
state: Florida
city: Atlanta
country: United States
facility: Emory Midtown Infectious Disease Clinic /ID# 229927
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics /ID# 226934
state: Iowa
city: Lexington
country: United States
facility: Duplicate_University of Kentucky Chandler Medical Center /ID# 231588
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville Hospital /ID# 232139
state: Kentucky
city: Baltimore
country: United States
facility: Mercy Medical Center /ID# 226937
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital /ID# 230694
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Hospital /ID# 226932
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi Medical Center /ID# 232620
state: Mississippi
city: Las Vegas
country: United States
facility: Las Vegas Research Center /ID# 255631
state: Nevada
city: Newark
country: United States
facility: North Jersey Community Research Initiative (NJCRI) /ID# 245129
state: New Jersey
city: New York
country: United States
facility: Weill Cornell Medical College /ID# 230815
state: New York
city: Fayetteville
country: United States
facility: Coastal Research Institute, LLC /ID# 233233
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital /ID# 231204
state: Ohio
city: Cincinnati
country: United States
facility: Duplicate_University Of Cincinnati Medical Center /ID# 226922
state: Ohio
city: Tahlequah
country: United States
facility: Cherokee Nation Outpatient Health Center /ID# 232618
state: Oklahoma
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital /ID# 232624
state: Pennsylvania
city: Providence
country: United States
facility: University Gastroenterology /ID# 233332
state: Rhode Island
city: Nashville
country: United States
facility: Vanderbilt University Medical Center /ID# 241282
state: Tennessee
city: Houston
country: United States
facility: Liver Associates of Texas, P.A /ID# 229775
state: Texas
city: Norfolk
country: United States
facility: Digestive and Liver Disease Sp /ID# 232633
state: Virginia
city: Milwaukee
country: United States
facility: Wisconsin Medical Center /ID# 230116
state: Wisconsin
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital /ID# 227167
state: South Australia
city: Melbourne
country: Australia
facility: The Alfred Hospital /ID# 227169
state: Victoria
city: Sankt Poelten
country: Austria
facility: Universitaetsklinikum St. Poelten /ID# 227098
state: Niederoesterreich
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 226985
state: Oberoesterreich
city: Vienna
country: Austria
facility: Medizinische Universitaet Wien /ID# 226938
state: Wien
city: Vancouver
country: Canada
facility: Vancouver Infectious Diseases Centre /ID# 227125
state: British Columbia
city: Victoria
country: Canada
facility: CoolAid Medical Clinic /ID# 239978
state: British Columbia
city: Hamilton
country: Canada
facility: Charlton Medical Centre /ID# 228100
state: Ontario
city: Montreal
country: Canada
facility: Royal Victoria Hospital / McGill University Health Centre /ID# 227126
state: Quebec
city: Montpellier Cedex 5
country: France
facility: CHU Montpellier - Hopital Saint Eloi /ID# 229083
state: Herault
city: Clichy
country: France
facility: Hopital Beaujon /ID# 246817
state: Ile-de-France
city: TOURCOING Cedex
country: France
facility: CH de Tourcoing /ID# 233732
state: Nord
city: Creteil
country: France
facility: Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 259111
state: Paris
city: Lyon
country: France
facility: HCL - Hopital de la Croix-Rousse /ID# 229077
state: Rhone
city: Lyon
country: France
facility: HCL - Hopital de la Croix-Rousse /ID# 259102
state: Rhone
city: Paris
country: France
facility: AP-HP - Hopital Saint-Antoine /ID# 229070
city: Frankfurt am Main
country: Germany
facility: Infektiologikum /ID# 226880
state: Hessen
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn /ID# 226764
state: Nordrhein-Westfalen
city: Dortmund
country: Germany
facility: Klinikum Dortmund gGmbH /ID# 249689
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: zibp-Zentrum fuer Infektiologie /ID# 226765
city: Hamburg
country: Germany
facility: ICH Study Center GmbH & Co KG /ID# 228162
city: Munich
country: Germany
facility: Klinikum rechts der Isar /ID# 226783
city: Bologna
country: Italy
facility: IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 227080
state: Emilia-Romagna
city: Milan
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 227079
state: Milano
city: Naples
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II /ID# 227183
state: Napoli
city: Rome
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 227078
state: Roma
city: Foggia
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia /ID# 227081
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol /ID# 226698
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Parc de Salut del Mar /ID# 226696
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona /ID# 226695
city: Madrid
country: Spain
facility: Centro Sanitario Sandoval /ID# 226954
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor /ID# 251780
city: Valencia
country: Spain
facility: Duplicate_Hospital General Universitario de Valencia /ID# 226709
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: