Treatment of chronic hepatitis C in children aged 6 – 18 years using a direct-acting antiviral (sofosbuvir/velpatasvir) acting against all HCV genotypes

Phase 1

• Conditions: Chronic hepatitis C; MedDRA version: 20.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-003879-18-PL
• Lead Sponsor: Medical University of Warsaw

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-17
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

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

Inclusion Criteria

• written, voluntary informed consent to participate in the study
• diagnosis of chronic hepatitis C
• age 6-18 years
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
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

• refusal to consent to participate in the study
• hypersensitivity to the active substance or excipients of the drug
• no HCV RNA in blood serum in the presence of anti-HCV antibodies
• pregnancy or breastfeeding
• hepatitis B infection (active or past)
• simultaneous intake of drugs that affect the interaction with active substances, including rosuvastatin or strong inhibitors of P-glycoprotein
• active addiction to alcohol or intoxicants

Study & Design

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