A Single-Arm Retrospective Study to Evaluate Safety and Efficacy in Patients with Acute Hepatitis C Virus (HCV) Infection Treated with 8 Weeks of Glecaprevir/Pibrentasvir

Study identification

• EU PAS number:
  EUPAS39656
• Study ID:
  48811
• Official title and acronym:
  A Single-Arm Retrospective Study to Evaluate Safety and Efficacy in Patients with Acute Hepatitis C Virus (HCV) Infection Treated with 8 Weeks of Glecaprevir/Pibrentasvir
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Canada

  France

  Italy

  Spain

  United Kingdom

  United States
• Study description:
  This study aims to demonstrate safety and efficacy for once-daily (QD)glecaprevir (GLE) and pibrentasvir (PIB) at the dose of GLE 300 mg and PIB 120 mg in acute HCV patients.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Planned:01/05/2020

Actual:01/05/2020

Study start date

Planned:29/04/2021

Actual:20/05/2021

Date of final study report

Planned:13/12/2022

Actual:22/02/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AbbVie

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

H20-315, P20-315