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

NCT05992077 | Active Not Recruiting DMC

• 1 other identifier: ANRS 12420 HEPEDIAC
• Study Type: interventional
• Target: 21,000
• Locations: 1 country
• Sites: 4

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

Conditions

HCV Infection

Outcome Measures

Primary Outcomes (1)

• Evaluation of the effectiveness of sofosbuvir/daclatasvir combination for children aged ≥ 6 years old and adolescents with active HCV infection in Cambodia

  The proportion of patients with sustained virologic response defined by HCV RNA below the lower limit of quantification range of the viral load (undetectable viral load) 12 weeks after discontinuation of study drugs (SVR12). Detectable HCV RNA at the SVR12 study visit, permanent discontinuation of DAA, death, discontinuation of the study (loss to follow-up, transfer-out) will be considered as failures.

  24 months

Secondary Outcomes (5)

• Evaluation of the liver-related events

  24 months

• Occurrence of grade 3-4 adverse events (ANRS grading table);

  24 months

• Adherence

  24 months

• Maximal Plasma Concentration (Cmax) of DAA

  24 months

• Area under the plasma concentration versus time curve over the dosing interval (AUCtau) of DAA

  24 months

Other Outcomes (1)

• Risk factors of HCV acquisition through questionnaire

  24 months

Study Arms (1)

Therapeutic phase

EXPERIMENTAL

Children and adolescents confirmed with active HCV infection (positive HCV RNA) during the screening 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.

Drug: Sofosbuvir/Daclatasvir

Interventions

Sofosbuvir/Daclatasvir DRUG

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.

Therapeutic phase

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged ≥ 6 years old with weight ≥ 14 kg
• Aged \<18 years old
• \- Any concomitant medical condition that, according to the clinical site investigator, would contraindicate the HCV screening
• 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
• 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

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• Institute Pasteur, Cambodia: collaborator

Study Sites (4)

Battambang Provincial Hospital

Battambang, Cambodia

Location

Kantha Bopha Hospital

Phnom Penh, Cambodia

Location

National Pediatric Hospital

Phnom Penh, Cambodia

Location

Jayavarman VII Hospital

Siem Reap, Cambodia

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Sofosbuvir; daclatasvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Non-comparative multicenter pilot therapeutic prospective study. First, all children aged ≥ 6 years old and adolescents (expected 21000 participants) will be screened for HCV infection using HCV rapid test. HCV RNA will be performed in case of HCV rapid test positivity. Then, children and adolescents confirmed with active HCV infection (positive HCV RNA) during the screening phase will be referred to a specific consultation for treatment after evaluation of liver disease. We expect to enroll 60 participants in the therapeutic phase.

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: August 15, 2023
• Study Start: August 7, 2023
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-10

Locations

CA (4)