Befejeződött3. fázis
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)
A legfontosabb adatok
- Ki végzi
- AbbVie
- Hol
- 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 és Zephyrhills (Egyesült Államok)Mind a 37 helyszín megnézéseMég 7 másik országban, 33 helyszínen
- Azonosító
- Állapot
- Befejeződött
- Fázis
- 3. fázis
- Résztvevők
- 286 fő vett részt
- Kezdés
- 2021. aug. 24.
- Befejezés
- 2024. szept. 17.
- A vizsgálat típusa
- Beavatkozással járó
- A vizsgált kezelések
- Glecaprevir/Pibrentasvir (GLE/PIB)
- A regiszteradat frissítve
- 2025. április 6.
Ki vehet részt
- Életkor
- 12 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 5 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- Participants with prior treatment, including interferon for this HCV infection
- History of liver decompensation
Helyszínek itt: Egyesült Államok
Még 7 másik országban, 33 helyszínen
- Emory Midtown Infectious Disease Clinic /ID# 229927Atlanta, Egyesült ÁllamokNo longer taking part
- Johns Hopkins Hospital /ID# 230694Baltimore, Egyesült ÁllamokNo longer taking part
- Mercy Medical Center /ID# 226937Baltimore, Egyesült ÁllamokNo longer taking part
- AHF Research Center /ID# 254795Beverly Hills, Egyesült ÁllamokNo longer taking part
- Arizona Health Research /ID# 233558Chandler, Egyesült ÁllamokNo longer taking part
- Velocity Clinical Research Chula Vista /ID# 238352Chula Vista, Egyesült ÁllamokNo longer taking part
- Duplicate_University Of Cincinnati Medical Center /ID# 226922Cincinnati, Egyesült ÁllamokNo longer taking part
- The Christ Hospital /ID# 231204Cincinnati, Egyesült ÁllamokNo longer taking part
- Henry Ford Hospital /ID# 226932Detroit, Egyesült ÁllamokNo longer taking part
- Angels Clinical Research Institute /ID# 234090Doral, Egyesült ÁllamokNo longer taking part
- Coastal Research Institute, LLC /ID# 233233Fayetteville, Egyesült ÁllamokNo longer taking part
- AIDS Healthcare Foundation (AHF) - Healthcare Center - Northpoint /ID# 254814Fort Lauderdale, Egyesült ÁllamokNo longer taking part
- Midway Immunology and Research Center /ID# 229194Ft. Pierce, Egyesült ÁllamokNo longer taking part
- Liver Associates of Texas, P.A /ID# 229775Houston, Egyesült ÁllamokNo longer taking part
- University of Iowa Hospitals and Clinics /ID# 226934Iowa City, Egyesült ÁllamokNo longer taking part
- University of Mississippi Medical Center /ID# 232620Jackson, Egyesült ÁllamokNo longer taking part
- Las Vegas Research Center /ID# 255631Las Vegas, Egyesült ÁllamokNo longer taking part
- Duplicate_University of Kentucky Chandler Medical Center /ID# 231588Lexington, Egyesült ÁllamokNo longer taking part
- Liver Wellness Center /ID# 244933Little Rock, Egyesült ÁllamokNo longer taking part
- AHF Healthcare Center- Hollywood /ID# 254794Los Angeles, Egyesült ÁllamokNo longer taking part
- TLC Clinical Research Inc /ID# 232334Los Angeles, Egyesült ÁllamokNo longer taking part
- University of Louisville Hospital /ID# 232139Louisville, Egyesült ÁllamokNo longer taking part
- Wisconsin Medical Center /ID# 230116Milwaukee, Egyesült ÁllamokNo longer taking part
- Vanderbilt University Medical Center /ID# 241282Nashville, Egyesült ÁllamokNo longer taking part
- Weill Cornell Medical College /ID# 230815New York, Egyesült ÁllamokNo longer taking part
- North Jersey Community Research Initiative (NJCRI) /ID# 245129Newark, Egyesült ÁllamokNo longer taking part
- Digestive and Liver Disease Sp /ID# 232633Norfolk, Egyesült ÁllamokNo longer taking part
- Midland Research Group, Inc /ID# 231885Oakland Park, Egyesült ÁllamokNo longer taking part
- Orlando Immunology Center /ID# 229839Orlando, Egyesült ÁllamokNo longer taking part
- The Institute for Liver Health /ID# 228427Peoria, Egyesült ÁllamokNo longer taking part
- Thomas Jefferson University Hospital /ID# 232624Philadelphia, Egyesült ÁllamokNo longer taking part
- University Gastroenterology /ID# 233332Providence, Egyesült ÁllamokNo longer taking part
- University of California, Davis Comprehensive Cancer Center /ID# 230814Sacramento, Egyesült ÁllamokNo longer taking part
- Cherokee Nation Outpatient Health Center /ID# 232618Tahlequah, Egyesült ÁllamokNo longer taking part
- Tampa General Hospital /ID# 228930Tampa, Egyesült ÁllamokNo longer taking part
- Duplicate_Triple O Research Institute /ID# 229928West Palm Beach, Egyesült ÁllamokNo longer taking part
- Florida Medical Clinic /ID# 233489Zephyrhills, Egyesült ÁllamokNo longer taking part
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A teljes eredeti leírásKevesebb
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.
A vizsgálat csoportja
- Glecaprevir/PibrentasvirA vizsgált kezelés
Participants treated once daily (QD) with glecaprevir/pibrentasvir 300 mg/120 mg for 8 weeks.
Kezelés: Glecaprevir/Pibrentasvir (GLE/PIB)
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- 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
- Publikációk
- Glecaprevir/Pibrentasvir for Acute Hepatitis C Virus Infection in Individuals with a History of Prior Hepatitis C Infection.Infectious diseases and therapy, 2026
- A single-arm phase IIIb study of 8-week glecaprevir/pibrentasvir treatment in adults with acute hepatitis C.Journal of hepatology, 2026
- A regiszteradat frissítve
- 2025. április 6.