Six weeks of Glecaprevir/ pibrentasvir for patients with acute HCV infection.

Phase 1

• Conditions: Acute HCV infection; MedDRA version: 20.1Level: LLTClassification code 10047457Term: Viral hepatitis CSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2017-002221-37-IT
• Lead Sponsor: AZIENDA OSPEDALIERA UNIVERSITARIA POLICLINICO PAOLO GIACCONE” DI PALERMO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-04
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Inclusion Criteria will be:
-Adult patients (=18 years);
-Presenting acute HCV infection (all genotypes);
-With or without HIV co-infection;
-Active or inactive drug users

Diagnosis of AHC:
Acute HCV infection was defined as either a documented seroconversion to HCV antibody positivity within the 4 months before screening, or known or suspected exposure to HCV within the 4 months before
screening with raised alanine aminotransferase concentration more than ten times the upper limit of
normal at screening or within a 4-week period before screening.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

-Patients fulfilling the criteria for acute liver failure (evidence of coagulation abnormality, INR > 1.5, and any degree of encephalopathy) (6).
-HBV co-infection;
-Patients with previous HCV infection cured by DAA regimens who were reinfected after HCV clearance
-Patients with chronic liver disease of any other etiology (NASH, ASH, autoimmune, metabolic);
-Concomitant use with atazanavir and rifampicin;
-Hypersensitivity to the active substances or to any of the excipients;
-Pregnancy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified