Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Sustained Virological Response 4 (SVR4) by Hepatitis C Virus (HVC) RNA Polymerase Chain Reaction (PCR)
研究概览
简要总结
REDEMPTION (Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods) is observing and collating the treatment course, safety profile, and outcomes of patients around the world who are choosing to self import generic versions of the Direct Acting Antivirals Sofosbuvir, Ledipasvir and Daclatasvir from countries like China, India and Bangladesh.
详细描述
The high prices of Hepatitis C Virus (HCV) Direct Acting Antiviral (DAA) medications in many countries have led patients to seek out less expensive generic alternatives.
The efficacy and safety of these generic medications has not been formally demonstrated in clinical practice.
The primary goal of REDEMPTION is to collate the clinical results of these generic medications.
The secondary goal is to answer efficacy questions for which there is currently insufficient trial data available - for example Sofosbuvir+Daclatasvir appears to be an inexpensive pan genotypic solution to treat HCV globally but this is supported by a total n of less than 1000, and in some common genotypes, such as HCV Genotype 2, by an n of only 52 making for a wide margin of error and a high degree of uncertainty.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 82 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Quantitative HCV RNA > 100
排除标准
- •Contraindications to DAA medications
研究组 & 干预措施
Sofosbuvir+Ledipasvir
Following patients treating with Sofosbuvir+Ledipasvir
干预措施: Sofosbuvir+Ledipasvir (Drug)
Sofosbuvir+Daclatasvir
Following patients treating with Sofosbuvir+Daclatasvir
干预措施: Sofosbuvir+Daclatasvir (Drug)
Sofosbuvir+Velpatasvir
Following patients treating with Sofosbuvir+Velpatasvir
干预措施: Sofosbuvir+Velpatasvir (Drug)
结局指标
主要结局
Sustained Virological Response 4 (SVR4) by Hepatitis C Virus (HVC) RNA Polymerase Chain Reaction (PCR)
时间窗: 4-7 months
Viral load 4 weeks after cessation of treatment as measured by HCV RNA PCR, where SVR is defined as HCV RNA \< Lower Limit Of Quantification (LLOQ)
次要结局
- Side Effects(3-6 months)
- Rapid Virological Response (RVR) by HCV RNA PCR(4 weeks)
- End Of Treatment (EOT) Response by HCV RNA PCR(3-6 months)
- Sustained Virological Response (SVR12) by HCV RNA PCR(6-12 months)