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)

Hepatitis C Virus (HCV) Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04903626
• Other study ID #: M20-350
• Secondary ID: 2020-005777-27
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 24, 2021
• Est. completion date: August 26, 2024

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hepatitis C Virus (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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 286
• Est. completion date: August 26, 2024
• Est. primary completion date: August 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Evidence of acute Hepatitis C Virus (HCV) infection prior to enrollment, defined as a physician diagnosis of acute HCV infection, quantifiable HCV RNA at screening, and at least 1 of the following:

• Negative anti-HCV antibody, HCV Ribonucleic Acid (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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus (HCV)
• Infections

Intervention

Drug:
• Glecaprevir/Pibrentasvir (GLE/PIB)
Oral tablets

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  France,  Germany,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virological Response 12 Weeks Post-treatment (SVR12) in the Intention-to-Treat (ITT) Population	SVR12 is defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification (	12 weeks after last dose of study drug (Week 20)
Secondary	Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12) in the Modified ITT-Virologic Failure (mITT-VF) Population.	SVR12 is defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification (	12 weeks after last dose of study drug (Week 20)
Secondary	Percentage of Participants With On-Treatment Virologic Failure in the ITT Population	On-treatment virologic failure is defined as confirmed increase in HCV RNA of > 1 log10 IU/mL above nadir during treatment, confirmed HCV RNA >= 100 IU/mL after HCV RNA < lower limit of quantification (LLOQ) during treatment, or HCV RNA >= LLOQ at the end of treatment (EOT) with at least 6 weeks of treatment.	Up to week 8
Secondary	Percentage of Participants With Post-Treatment Relapse in the ITT Population	Post-treatment (PT) relapse is defined as confirmed HCV RNA >= LLOQ between the end of treatment (EOT) and 12 weeks after the last dose of study drug among participants who completed treatment as planned with HCV RNA < LLOQ at the EOT and with at least 1 PT HCV RNA value, excluding cases of reinfection.	Up to 12 weeks after the last dose of study drug (Week 20)
Secondary	Percentage of Participants With Post-Treatment Reinfection With HCV in the ITT Population	Post-treatment (PT) reinfection is defined as confirmed HCV RNA >= LLOQ in the PT period along with the PT detection of a different HCV genotype, subtype, or clade compared with baseline.	Up to 12 weeks after the last dose of study drug (Week 20)

External Links

•   This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.