Treatment for Children and Adolescents with HCV in Cambodia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Kantha Bopha
  Phnom Penh, Cambodia Recruiting
• National Pediatric Hospital
  Phnom Penh, Cambodia Recruiting
• Jayavarman VII Hospital
  Siem Reap, Cambodia Recruiting
• Battambang Provincial Hospital
  Battambang, Cambodia Not yet recruiting

Study contacts

• Study coordinator: Fatoumata Coulibaly
• Email: fatoumata.coulibaly@anrs.fr
• Phone: 0144236110

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.