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CompletedPhase 3

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)

Key facts

Who runs it
AbbVie
Where
Atlanta, Baltimore, Beverly Hills, Chandler, Chula Vista, Cincinnati, Detroit, Doral, Fayetteville, Fort Lauderdale, Ft. Pierce, Houston, Iowa City, Jackson, Las Vegas, Lexington, Little Rock, Los Angeles, Louisville, Milwaukee, Nashville, New York, Newark, Norfolk, Oakland Park, Orlando, Peoria, Philadelphia, Providence, Sacramento, Tahlequah, Tampa, West Palm Beach, and Zephyrhills, United StatesSee the 37 sitesAlso in 7 other countries, 33 sites
Status
Completed
Phase
Phase 3
People taking part
286 people enrolled
Started
24 Aug 2021
Ended
17 Sept 2024
Type of study
Interventional
Treatments tested
  • Glecaprevir/Pibrentasvir (GLE/PIB)
Record updated
6 April 2025

Who can take part

Age
12 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 5 criteriaShow less

Who can take part

  • 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

Who cannot take part

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

Where in United States

Also in 7 other countries, 33 sites

  • Emory Midtown Infectious Disease Clinic /ID# 229927Atlanta, United StatesNo longer taking part
  • Johns Hopkins Hospital /ID# 230694Baltimore, United StatesNo longer taking part
  • Mercy Medical Center /ID# 226937Baltimore, United StatesNo longer taking part
  • AHF Research Center /ID# 254795Beverly Hills, United StatesNo longer taking part
  • Arizona Health Research /ID# 233558Chandler, United StatesNo longer taking part
  • Velocity Clinical Research Chula Vista /ID# 238352Chula Vista, United StatesNo longer taking part
  • Duplicate_University Of Cincinnati Medical Center /ID# 226922Cincinnati, United StatesNo longer taking part
  • The Christ Hospital /ID# 231204Cincinnati, United StatesNo longer taking part
  • Henry Ford Hospital /ID# 226932Detroit, United StatesNo longer taking part
  • Angels Clinical Research Institute /ID# 234090Doral, United StatesNo longer taking part
  • Coastal Research Institute, LLC /ID# 233233Fayetteville, United StatesNo longer taking part
  • AIDS Healthcare Foundation (AHF) - Healthcare Center - Northpoint /ID# 254814Fort Lauderdale, United StatesNo longer taking part
  • Midway Immunology and Research Center /ID# 229194Ft. Pierce, United StatesNo longer taking part
  • Liver Associates of Texas, P.A /ID# 229775Houston, United StatesNo longer taking part
  • University of Iowa Hospitals and Clinics /ID# 226934Iowa City, United StatesNo longer taking part
  • University of Mississippi Medical Center /ID# 232620Jackson, United StatesNo longer taking part
  • Las Vegas Research Center /ID# 255631Las Vegas, United StatesNo longer taking part
  • Duplicate_University of Kentucky Chandler Medical Center /ID# 231588Lexington, United StatesNo longer taking part
  • Liver Wellness Center /ID# 244933Little Rock, United StatesNo longer taking part
  • AHF Healthcare Center- Hollywood /ID# 254794Los Angeles, United StatesNo longer taking part
  • TLC Clinical Research Inc /ID# 232334Los Angeles, United StatesNo longer taking part
  • University of Louisville Hospital /ID# 232139Louisville, United StatesNo longer taking part
  • Wisconsin Medical Center /ID# 230116Milwaukee, United StatesNo longer taking part
  • Vanderbilt University Medical Center /ID# 241282Nashville, United StatesNo longer taking part
  • Weill Cornell Medical College /ID# 230815New York, United StatesNo longer taking part
  • North Jersey Community Research Initiative (NJCRI) /ID# 245129Newark, United StatesNo longer taking part
  • Digestive and Liver Disease Sp /ID# 232633Norfolk, United StatesNo longer taking part
  • Midland Research Group, Inc /ID# 231885Oakland Park, United StatesNo longer taking part
  • Orlando Immunology Center /ID# 229839Orlando, United StatesNo longer taking part
  • The Institute for Liver Health /ID# 228427Peoria, United StatesNo longer taking part
  • Thomas Jefferson University Hospital /ID# 232624Philadelphia, United StatesNo longer taking part
  • University Gastroenterology /ID# 233332Providence, United StatesNo longer taking part
  • University of California, Davis Comprehensive Cancer Center /ID# 230814Sacramento, United StatesNo longer taking part
  • Cherokee Nation Outpatient Health Center /ID# 232618Tahlequah, United StatesNo longer taking part
  • Tampa General Hospital /ID# 228930Tampa, United StatesNo longer taking part
  • Duplicate_Triple O Research Institute /ID# 229928West Palm Beach, United StatesNo longer taking part
  • Florida Medical Clinic /ID# 233489Zephyrhills, United StatesNo longer taking part

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The group in the trial

  • Glecaprevir/PibrentasvirTreatment being tested

    Participants treated once daily (QD) with glecaprevir/pibrentasvir 300 mg/120 mg for 8 weeks.

    Treatment: Glecaprevir/Pibrentasvir (GLE/PIB)

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Publications
Record updated
6 April 2025