A Study to Evaluate Glecaprevir/Pibrentasvir in the Treatment of Hepatitis C Virus Infection in Childre

Phase 1

• Conditions: Chronic Hepatitis C Infection; MedDRA version: 20.0Level: LLTClassification code 10019752Term: Hepatitis C virus (HCV)System Organ Class: 100000004848; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2016-004102-34-DE
• Lead Sponsor: AbbVie Deutschland GmbH & Co.KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-14
• Study Completion: 2022-09-12
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

1. Hepatitis C Virus (HCV) infection demonstrated by positive anti-HCV antibody (Ab) and HCV Ribonucleic acid (RNA) greater than or equal to 1000 IU/ mL.
2. Subject must have a weight consistent with a recommended weight range for their age at the time of screening. Subjects that fall out of the weight band for their age at the time of screening may be screened only into the safety and efficacy parts of the study upon TA MD approval.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Females who are pregnant or breastfeeding.
2. Positive test result for Hepatitis B surface antigen (HbsAg) or positive test result for HBV DNA.
3. Participants with other known liver diseases.
4. Decompensated cirrhosis defined as: presence of ascites, history of variceal bleeding, lab values consistent with Child's class B or C cirrhosis.

Study & Design

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