Pilot Therapeutic Study of DAA Treatment for Children and Adolescents With Active HCV Infection in Cambodia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 21,000
- 试验地点
- 4
- 主要终点
- Evaluation of the effectiveness of sofosbuvir/daclatasvir combination for children aged ≥ 6 years old and adolescents with active HCV infection in Cambodia
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Therapeutic phase
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.
干预措施: Sofosbuvir/Daclatasvir (Drug)
结局指标
主要结局
Evaluation of the effectiveness of sofosbuvir/daclatasvir combination for children aged ≥ 6 years old and adolescents with active HCV infection in Cambodia
时间窗: 24 months
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.
次要结局
- 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)