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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003879-18-PL

Enrollment

Registered

2020-11-17

Start date

2021-04-21

Completion date

Unknown

Last updated

2024-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatitis C MedDRA version: 20.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Epclusa (Sofosbuvir/Velpatasvir) Product Name: Epclusa (sofosbuvir/velpatasvir) Pharmaceutical Form: Tablet INN or Proposed INN: Sofosbuvir CAS Number: 1190307-88-0 Other descriptive name:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Main objective: to cure patients with chronic hepatitis C: evaluation of the efficacy of sofosbuvir / velpatasvir (SOF / VEL) therapy assessed as SVR (sustained viral response) 12 weeks after the end of treatment;Secondary Objective: Secondary goals: • assessment of the safety of therapy, • monitoring of patients during treatment, • long-term post-treatment evaluation of patients - assessment of the durability of treatment effects and possible long-term side effects, including effects on children's development;Primary end point(s): Assessment of the efficacy of sofosbuvir / velpatasvir (SOF / VEL) therapy assessed as SVR (sustained viral response) 12 weeks after the end of treatment; ;Timepoint(s) of evaluation of this end point: 12 weeks after the end of the treatment	—

Measure

Time frame

Main Objective: Main objective: to cure patients with chronic hepatitis C: evaluation of the efficacy of sofosbuvir / velpatasvir (SOF / VEL) therapy assessed as SVR (sustained viral response) 12 weeks after the end of treatment;Secondary Objective: Secondary goals: • assessment of the safety of therapy, • monitoring of patients during treatment, • long-term post-treatment evaluation of patients - assessment of the durability of treatment effects and possible long-term side effects, including effects on children's development;Primary end point(s): Assessment of the efficacy of sofosbuvir / velpatasvir (SOF / VEL) therapy assessed as SVR (sustained viral response) 12 weeks after the end of treatment; ;Timepoint(s) of evaluation of this end point: 12 weeks after the end of the treatment

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Secondary

Measure	Time frame
Secondary end point(s): • change in liver enzyme levels • change in total bilirubin • reduction in HCV viral load after 4, 8 and 12 weeks of treatment • change in the stage of liver fibrosis in an elastographic examination, • change of the patient's physical parameters (body weight, height, BMI z-score), • assessment of the occurrence of side effects of treatment, • assessment of the impact of clinical and laboratory factors (including the HCV genotype) on the effectiveness of treatment, • patients' quality of life assessment ;Timepoint(s) of evaluation of this end point: 4, 8, 12 weeks after the beginning of the treatment; 12 weeks and a year after the end of the treatment	—

Measure

Time frame

Secondary end point(s): • change in liver enzyme levels • change in total bilirubin • reduction in HCV viral load after 4, 8 and 12 weeks of treatment • change in the stage of liver fibrosis in an elastographic examination, • change of the patient's physical parameters (body weight, height, BMI z-score), • assessment of the occurrence of side effects of treatment, • assessment of the impact of clinical and laboratory factors (including the HCV genotype) on the effectiveness of treatment, • patients' quality of life assessment ;Timepoint(s) of evaluation of this end point: 4, 8, 12 weeks after the beginning of the treatment; 12 weeks and a year after the end of the treatment

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Countries

Poland

Contacts

Public ContactMaria Pokorska-Spiewak

Medical University of Warsaw

maria.pokorska-spiewak@wum.edu.pl48223355250

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026