Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment
研究概览
简要总结
The study will recruit 150 patients with HCV related HCC ,after HCC treatment the patients will undergo treatment with different regimens of DAAs.
详细描述
The study will recruit 150 patients with HCV related HCC All the studied patients underwent or will undergo one of the curative interventions for HCC either hepatic resection or thermal ablation .
after 1 month of achievement of laboratory and radiological response to HCC intervention the patient will be treated with one of the interferon free regimens :
- Sofosbuvir+Ribavirin
- Sofosbuvir+Simeprevir± Ribavirin
- Sofosbuvir+ Daclatasvir ± Ribavirin
- Sofosbuvir+ Ledipasvir ± Ribavirin
the treatment duration will be justified either 12 or 24 weeks after treatment the patient will continue on regular follow up to detect HCV cure or recurrence , HCC cure or recurrence and long term follow up of natural history
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years old
- •Confirmed HCV viremia by PCR
- •CHILD Pugh "A" or "B7,B8"
- •Confirmed HCC either by laboratory ,imaging or histopathological criteria
- •Underwent or candidate for curative intervention for HCC (BCLC stage 0 ,A)
- •Willing to be treated for HCV and signing informed consent
排除标准
- •Patients below 18 or above 70 years old
- •patients with advanced liver condition "CHILD score ≥ B9"
- •Patients with advanced HCC status (BCLC≥ B)
- •Patients with combined HBV ,HIV infection
研究组 & 干预措施
Sofosbuvir+Ledipasvir±Ribavirin
Sofosbuvir 400 mg/day +Ledipasvir 90 mg/day ±ribavirin for 12 weeks
干预措施: Ribavirin (Drug)
Sofosbuvir+Ledipasvir±Ribavirin
Sofosbuvir 400 mg/day +Ledipasvir 90 mg/day ±ribavirin for 12 weeks
干预措施: Ledipasvir (Drug)
Sofosbuvir +Ribavirin
Sofosbuvir 400 mg/day +ribavirin for 24 weeks
干预措施: Sofosbuvir (Drug)
Sofosbuvir+Simeprevir±Ribavirin
Sofosbuvir 400 mg/day +Simeprevir 150 mg/day ± ribavirin for 12 weeks
干预措施: Sofosbuvir (Drug)
Sofosbuvir +Ribavirin
Sofosbuvir 400 mg/day +ribavirin for 24 weeks
干预措施: Ribavirin (Drug)
Sofosbuvir+Simeprevir±Ribavirin
Sofosbuvir 400 mg/day +Simeprevir 150 mg/day ± ribavirin for 12 weeks
干预措施: Ribavirin (Drug)
Sofosbuvir+Simeprevir±Ribavirin
Sofosbuvir 400 mg/day +Simeprevir 150 mg/day ± ribavirin for 12 weeks
干预措施: Simeprevir (Drug)
Sofosbuvir+Daclatasvir±Ribavirin
Sofosbuvir 400 mg/day +Daclatasvir 60 mg/day ± ribavirin for 12 weeks
干预措施: Sofosbuvir (Drug)
Sofosbuvir+Daclatasvir±Ribavirin
Sofosbuvir 400 mg/day +Daclatasvir 60 mg/day ± ribavirin for 12 weeks
干预措施: Ribavirin (Drug)
Sofosbuvir+Daclatasvir±Ribavirin
Sofosbuvir 400 mg/day +Daclatasvir 60 mg/day ± ribavirin for 12 weeks
干预措施: daclatasvir (Drug)
Sofosbuvir+Ledipasvir±Ribavirin
Sofosbuvir 400 mg/day +Ledipasvir 90 mg/day ±ribavirin for 12 weeks
干预措施: Sofosbuvir (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment
时间窗: 12 weeks after the last dose of study drugs
次要结局
- Percentage of participants with virologic failure during treatment or relapse after treatment(from baseline until 12 weeks after the last dose of study drugs)
- Percentage of Participants who will show any radiological or laboratory changes denoting local or denovo recurrence of HCC(Follow up will be done from baseline for up to 36 months for detection of sustained HCC treatment,tumoral progression or denovo occurrence)
研究者
Mohamed Hassany
Hepatology & Gastroenterology Consultant , Director of HCC Unit
National Hepatology & Tropical Medicine Research Institute