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)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 286 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C Virus (HCV)

Interventions

Type	Name	Description
DRUG	Glecaprevir/Pibrentasvir (GLE/PIB)	Oral tablets

Timeline

• Start date: 2021-08-24
• Primary completion: 2024-09-17
• Completion: 2024-09-17
• First posted: 2021-05-26
• Last updated: 2025-04-06
• Results posted: 2025-04-06

Locations

70 sites across 8 countries: United States, Australia, Austria, Canada, France, Germany, Italy, Spain

Regulatory

• FDA-regulated drug study