Treatment for Children and Adolescents with HCV in Cambodia
Pilot Therapeutic Study of DAA Treatment for Children and Adolescents With Active HCV Infection in Cambodia
This study is testing a combination treatment for kids and teens with Hepatitis C in Cambodia to see if it helps them get better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 21000 (estimated) |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Sponsor | ANRS, Emerging Infectious Diseases Government |
| Locations | 4 sites (Battambang and 3 other locations) |
| Trial ID | NCT05992077 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a combination treatment of sofosbuvir and daclatasvir for children aged 6 years and older, as well as adolescents with active Hepatitis C Virus (HCV) infection in Cambodia. The study is divided into two phases: a screening phase to identify eligible participants through rapid testing and a therapeutic phase where confirmed cases receive the treatment for 12 weeks. The trial aims to assess the treatment's efficacy and gather data on risk factors associated with HCV acquisition in pediatric populations.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 17 years with a confirmed active HCV infection and a weight of at least 14 kg.
Not a fit: Patients with medical conditions requiring intensive care or acute surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve health outcomes for children and adolescents suffering from HCV infection.
How similar studies have performed: Other studies have shown success with similar antiviral treatments for HCV, indicating a promising approach for this population.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Battambang and 3 other locations
- Battambang Provincial Hospital — Battambang, Cambodia (Not_yet_recruiting)
- Kantha Bopha — Phnom Penh, Cambodia (Recruiting)
- National Pediatric Hospital — Phnom Penh, Cambodia (Recruiting)
- Jayavarman VII Hospital — Siem Reap, Cambodia (Recruiting)
Study contacts
- Study coordinator: Fatoumata Coulibaly
- Email: fatoumata.coulibaly@anrs.fr
- Phone: 0144236110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.