Retreatment Efficacy of Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir + Ribavirin for Hepatitis C Virus Genotype 4 Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm
研究概览
简要总结
enrolled participants were treated orally with SOF plus a fixed dose combination of OBV/PTV/r plus RBV.
详细描述
Enrolled participants were treated orally with SOF plus a fixed dose combination of Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir plus Ribavirin (OBV/PTV/r plus RBV), which was administered orally based on the participants' tolerability. The primary end point was a sustained virological response (HCV RNA level < 15 IU/ mL), observed 12 weeks after the end of the treatment (SVR12).
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The experienced participants who were treated previously with (SOF/DCV) , (SOF/SMV), (SOF/RBV), or (SOF/pegINF/RBV).
- •The presence of compensated liver cirrhosis was documented by ultrasonographic examination, liver biopsy, results of Fibroscan or FIB-4 score, and laboratory markers, like FIB-4 > 3.25 (advanced fibrosis or cirrhosis), albumin < 3.5, total bilirubin > 1.2, and also confirmed by clinical characteristics such as lower limb edema, splenomegaly, esophageal varices.
排除标准
- •liver disease of non-HCV GT4 etiology, coinfection with hepatitis B or HIV
- •poorly controlled diabetes (HbA1C > 8)
- •participants, hepatocellular carcinoma, a history of extrahepatic malignancy in the 5 years prior to the study
- •renal failure
- •evidence of hepatic decompensation
- •blood picture abnormalities such as anemia (hemoglobin concentration of < 10 g/dL)
- •thrombocytopenia (platelets count < 50,000 cells/mm3).
- •major severe illness such as congestive heart failure and respiratory failure.
研究组 & 干预措施
Cirrhotic Participants
The experienced participants(113 participants) who failed prior DAA treatments. They were allocated to cirrhotic (30 participants) and treated for 12 weeks.
干预措施: SOF plus (OBV/PTV/r) plus RBV (Drug)
Non-cirrhotic Participants
The experienced non-cirrhotic participants(83 participants) who failed prior DAA treatments. They were treated for 12 weeks.
干预措施: SOF plus (OBV/PTV/r) plus RBV (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm
时间窗: 12 weeks after last dose
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) level \< 15 IU/ml 12 weeks after the last dose of drugs.
Number of Participants With Adverse Events in Each Treatment Arm
时间窗: Screening up to 12 weeks after last dose]
An adverse event (AE) is defined as any untoward medical occurrence in a participant clinical investigation after administering a pharmaceutical drugs Serious adverse event (SAE) is an event that results in death, life-threatening, requires hospitalization, or significant disability/incapacity
次要结局
- Percentage of Participants With Viral relapse(Up to 12 weeks after last dose)
研究者
Mohammed Abdel-Gabbar, Ph.D
Associate Prof
Beni-Suef University