Status:
ACTIVE_NOT_RECRUITING
Study of DAA Treatment for Children and Adolescents With Active HCV Infection in Cambodia
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
Institute Pasteur, Cambodia
Conditions:
HCV Infection
Eligibility:
All Genders
6-17 years
Phase:
NA
Brief Summary
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
Detailed Description
Non-comparative multicenter pilot therapeutic prospective study conducted in Phnom Penh, Siem Reap and Battambang province and divided in 2 phases: Screening phase: First, all children aged more tha...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Screening phase Inclusion criteria
- Aged ≥ 6 years old with weight ≥ 14 kg
- Aged \<18 years old
- 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 concomitant medical condition that, according to the clinical site investigator, would contraindicate the HCV screening
- 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
Exclusion
Key Trial Info
Start Date :
August 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
21000 Patients enrolled
Trial Details
Trial ID
NCT05992077
Start Date
August 7 2023
End Date
January 31 2026
Last Update
December 4 2025
Active Locations (4)
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1
Battambang Provincial Hospital
Battambang, Cambodia
2
Kantha Bopha Hospital
Phnom Penh, Cambodia
3
National Pediatric Hospital
Phnom Penh, Cambodia
4
Jayavarman VII Hospital
Siem Reap, Cambodia