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

Launched by ANRS, EMERGING INFECTIOUS DISEASES · Aug 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a combination treatment called sofosbuvir and daclatasvir for children and adolescents aged 6 to 17 years who have an active hepatitis C virus (HCV) infection in Cambodia. The trial aims to see how well this treatment works in helping these young patients recover from HCV. The study is currently recruiting participants, specifically children who are hospitalized in certain pediatric departments or who have been born to mothers with HIV or HCV.

To be eligible for the trial, participants must be at least 6 years old and weigh at least 14 kg. They should also have a detectable HCV infection and have never received treatment for it before. Parents or guardians need to provide consent, and children aged 13 and older will also share their agreement to join. Participants can expect to receive the study medication and will be monitored closely by the medical team throughout the trial. It's important to note that certain health conditions, like serious liver disease or other ongoing medical issues, may prevent someone from participating in this study.

Gender

ALL

Eligibility criteria

• 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