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

Phase

N/A

Condition

Hepatitis

Liver Disorders

Treatment

Sofosbuvir/Daclatasvir

Clinical Study ID

NCT05992077

ANRS 12420 HEPEDIAC

Ages 6-17
All Genders

Study 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

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

Study Design

Sofosbuvir/Daclatasvir

August 07, 2023

January 31, 2026

Study 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 than 6 years old and adolescents under 18 years old will be screened for HCV infection using Bioline HCV rapid test in several pediatric populations in Phnom Penh, Siem Reap and Battambang including children born from HIV/HCV co-infected women followed in OI/ART sites or born from HCV mono-infected women.

HCV RNA will be performed in case of HCV rapid test positivity. A case-control study will be performed to evaluate the risk factors associated to HCV acquisition. Cases will be defined as children with positive HCV RDT and controls as children with negative HCV RDT. Four controls will be randomly selected for one case.

Therapeutic phase:

Children and adolescents confirmed with active HCV infection (positive HCV RNA) during the first phase will be referred to a specific consultation in Kantha Bopha hospital in Phnom Penh, Jayavarman VII hospital in Siem Reap, National Pediatric Hospital and Battambang provincial hospital for treatment after evaluation of liver disease. Patients with a weight > 25 kg will be treated with a sofosbuvir/daclatasvir combination for 12 weeks with adult dose (400/60 mg), children with a weight between 14 and 25 kg will be treated with the same sofosbuvir/daclatasvir combination with the half adult dose (200/30 mg) for 12 weeks. For all children and adolescents, residual plasma concentrations (trough concentrations) of the drugs will be assessed after 2 weeks of treatment. For the first 20 children and adolescents included (10 children weighing between 14 and 25 kg and 10 weighing more than 25 kg), whatever their HIV status and ARV treatment, a complete pharmacokinetic analysis will be performed prior to drug administration and +1h, +2h, +6h and +10h after drugs intake. A non-compartimental analysis using Phoenix WinNonlin 8.1 (Certara, Princeton, NJ, USA) will be performed to estimate the pharmacokinetic parameters of sofosbuvir, GS-331007 and daclatasvir. Maximal concentration (Cmax), trough concentration at steady state (Ct), minimal concentration (Cmin) and the time required to reach Cmax (Tmax) are the observed parameters. The area under the curve (AUCtau) will be estimated by the linear up log down trapezoidal method using the predose concentration as 24-hour postdose concentrations.

Connect with a study center

Battambang Provincial Hospital
Battambang,
Cambodia
Site Not Available
Battambang Provincial Hospital
Battambang 1831797,
Cambodia
Site Not Available
Clinical Trial Unit (Ctu)
Phnom Penh, BP 983
Cambodia
Site Not Available
Kantha Bopha
Phnom Penh,
Cambodia
Active - Recruiting
National Pediatric Hospital
Phnom Penh,
Cambodia
Site Not Available
Kantha Bopha Hospital
Phnom Penh 1821306,
Cambodia
Site Not Available
National Pediatric Hospital
Phnom Penh 1821306,
Cambodia
Site Not Available
Jayavarman VII Hospital
Siem Reap,
Cambodia
Site Not Available
Jayavarman VII Hospital
Siem Reap 1822214,
Cambodia
Site Not Available

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