Pilot Therapeutic Study of DAA Treatment for Children and Adolescents With Active HCV Infection in Cambodia

ANRS 12420 HEPEDIAC

The goal of this clinical trial is to evaluate the effectiveness of sofosbuvir/daclatasvir combination for children aged ≥ 6 years old and adolescents with active HCV infection in Cambodia

2023-08-07

2024-12-01

2025-06-01

Recruiting

21000

Inclusion Criteria: Screening phase Inclusion criteria * Aged ≥ 6 years old with weight ≥ 14 kg * Aged \<18 years old * Hospitalized in one of the 3 paediatric departments of Kantha Bopha hospitals in Phnom Penh, Jayavarman VII hospital in Siem Reap OR in the pediatric department of the National Pediatric hospital OR born from HIV/HCV co-infected women followed in OI/ART sites in Phnom Penh * Informed consent obtained with information sheet given and explained before the inclusion visit, the consent form signed by at least one of the 2 parents or legal guardians and oral assent collected if the child ≥ 13 years old, at the latest the day of the inclusion Non-inclusion criteria - Any medical condition requiring intensive care and/or acute surgery Therapeutic phase Inclusion criteria * Aged ≥ 6 years old with weight ≥ 14 kg * Aged \< 18 years old * HCV RNA detectable * HCV treatment naive * In case of HIV coinfection, * HIV-1 infection confirmed according to Cambodian screening policies * On ART for more than 6 months * CD4 cell-count\> 100 cells/μL and \> 15% and HIV viral load \< 1000 copies/mL at inclusion visit * Informed consent obtained with information sheet given and explained before the inclusion visit and the consent form signed by at least one of the 2 parents and oral assent collected if the child ≥ 13 years old, before any sample or drug administration corresponding to the therapeutic phase. Non-inclusion Criteria: * Suspicion of evidence of hepato-cellular carcinoma (HCC) or any other neoplasia * Decompensated cirrhosis * Co-infection with HBV (positive HBsAg) * Advanced/terminal renal disease defined as serum creatinine clearance \< 30 mL/min * Active tuberculosis under treatment * In case of HIV coinfection, * Repeated ART failures and impossibility of prescription of an effective ART regimen * Active opportunistic infection (OI) * Current pregnancy or breast feeding * Use of any drug known to interact with Sofosbuvir or Daclatasvir and for which temporary cessation or dose modification would be impossible * Any concomitant medical condition that, according to the clinical site investigator, would contraindicate participation in the study * Concurrent participation in any other clinical trial without written agreement of the two study investigators

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Non-comparative multicenter pilot therapeutic prospective study. First, all children aged ≥ 6 years old and adolescents (expected 21000 participants) will be screened for HCV infection using HCV rapid test. HCV RNA will be performed in case of HCV rapid test positivity. Then, children and adolescents confirmed with active HCV infection (positive HCV RNA) during the screening phase will be referred to a specific consultation for treatment after evaluation of liver disease. We expect to enroll 60 participants in the therapeutic phase.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 21000, 'type': 'ESTIMATED'}}

2024-03-26