Direct Acting Antiviral Agent (DAA) Therapy Is Safe and Efficacious in Pediatric Patients With Chronic Hepatitis C: Real World Data From the Public Health Perspective
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Sustained Virological Response (SVR 12)
研究概览
简要总结
The Mukh-Mantri Punjab Hepatitis C Relief Fund (MMPHCRF) is a public health initiative for prevention and control of hepatitis C in the Punjab state, India. The efficacy of decentralised public health services and safety of 12- or 24-weeks of sofosbuvir (SOF) + ledipasvir (LDV) or SOF + daclatasvir (DCV) with or without ribavirin (RBV) in the treatment of pediatric chronic hepatitis C will be assessed
详细描述
Consecutive chronic hepatitis C (HCV) infected children [age: ≥12 to <18 years; both treatment-naïve (TN) and treatment-experienced, (TE)] are being enrolled.
Genotyping is not recommended for non-cirrhotic or TN patients and are treated with SOF+DCV for 12-weeks, while genotyping is recommended for patients with cirrhosis and TE patients.
Patients with liver cirrhosis or TE and genotype (GT)-3 are being treated with SOF+DCV for 24 weeks,
while non-GT-3 patients are being treated with SOF+LDV for 24-weeks. Patients < 35 kg are being given half doses of medications and patients ≥35 kg are being given adult dosages of SOF (400 mg), LDV (90 mg) and DCV (60 mg) per day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic hepatitis C, all genotypes
- •Ages eligible for study: ≥12 to <18 years (Child)
- •Gender eligible for study: either
- •Treatment-naive or treatment-experienced: either
排除标准
- •Chronic liver disease of a non-HCV etiology
- •serum creatinine >1.5 mg/dL
- •Evidence of hepatocellular carcinoma or other malignancy
- •Co-infection with hepatitis B virus, or HIV
- •Significant cardiovascular, pulmonary, or neurological disease
- •Evidence of a malabsorption syndrome that could interfere with absorption of orally administered medications
- •History of solid organ or bone marrow transplantation.
研究组 & 干预措施
Non cirrhotic
Sofosbuvir (SOF)+Daclatasvir (DCV) for 12 weeks Patients < 35 kg will be given half doses of medications and patients ≥35 kg will be given adult dosages of SOF (400 mg), LDV (90 mg) and DCV (60 mg) per day
干预措施: Direct Acting Antivirals (Drug)
Genotype 1,4,5 and 6 with cirrhosis
Sofosbuvir (SOF)+ Ledipasvir (LDV) for 12-weeks + weight based Ribavirin Patients < 35 kg will be given half doses of medications and patients ≥35 kg will be given adult dosages of SOF (400 mg) and LDV (90 mg) per day
干预措施: DAAs in Cirrhotics Genotye 1,4,5,6 (Drug)
Genotype 2 and 3 with Cirrhosis
Sofosbuvir (SOF)+Daclatasvir (DCV) for 12 weeks+ weight based Ribavirin Patients < 35 kg will be given half doses of medications and patients ≥35 kg will be given adult dosages of SOF (400 mg) and DCV (60 mg) per day
干预措施: DAAs in Cirrhotics Genotype 2/3 (Drug)
结局指标
主要结局
Sustained Virological Response (SVR 12)
时间窗: 12 weeks after completion of therapy
HCV RNA undetectable by quantitative Real time Polymerase Chain Reaction (PCR)
次要结局
未报告次要终点
研究者
Radha K Dhiman
Professor
Post Graduate Institute of Medical Education and Research, Chandigarh