Efficacy and Safety of Zoval (Sofosbuvir) and Ribavirin With or Without Interferon (Hepatitis Eradication Accuracy Trial of Sofosbuvir): An Observational Non-interventional Real Life Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 573
- 试验地点
- 1
- 主要终点
- Sustained Viralogical response (SVR)
研究概览
简要总结
Title Efficacy and Safety of Zoval (Sofosbuvir) and Ribavirin with or without Interferon among Pakistani Population: A real life trial Hepatitis Eradication Accuracy Trial of Sofosbuvir (HEATS) Study Design Endpoint Classification: Safety/Efficacy Study Intervention Model: Treatment agents (non-interventional observational study): Real life clinical practice study Masking: Open Label Primary Purpose: Treatment Duration Around 12 Months Study Centre Multi centric Study
详细描述
Indication Chronic Hepatitis C Virus (HCV) infection (serum HCV RNA level, >10,000 IU per milliliter) with or without cirrhosis Primary Objective o Proportion of participants with sustained virologic response 12/24 weeks after discontinuation of therapy (SVR 12 or 24 weeks) [ Time Frame: Post-treatment Week 12/24 ] [ Designated as safety issue: No ]
SVR 12/24 is defined as HCV RNA < the lower limit of quantification (LLOQ; ie, < 15 IU/mL) 12/24 weeks following the last dose of study medication.
Secondary Objective o Proportion of participants experiencing viral breakthrough [ Time Frame: Up to 12 or 24 weeks ] [ Designated as safety issue: No ] Viral breakthrough is defined as HCV RNA ≥ lower limit of quantification (LLOQ) after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be post treatment), or last available on-treatment measurement with no subsequent follow-up values.
- Proportion of participants experiencing viral relapse [ Time Frame: Up to Post treatment Week 12 or 24 ] [ Designated as safety issue: No ] Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post treatment measurement.
- Proportion of participants with Early Virological Response 4 weeks after start of therapy (EVR4) [ Time Frame: Treatment Week 4 ] [ Designated as safety issue: No ]
- SVR 12/24 is defined as HCV RNA < the lower limit of quantification (LLOQ; ie, < 15 IU/mL) 12/24 weeks following the last dose of study medication.Proportion of HCV RNA within 12 or 24 weeks change from baseline in HCV RNA (log10 IU/mL) [ Time Frame: Up to 12 or 24 weeks ] [ Designated as safety issue: No ]
- Proportion of participants experiencing an adverse event (AE) leading to permanent discontinuation of study medication [ Time Frame: Baseline to Week 12 or 24 ] [ Designated as safety issue: No ] Number of Subjects 5000 patients
Dosing - Sofosbuvir 400 mg tablet taken once daily orally
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
- 17 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, 18 years of age or older,
- •Treatment -Naïve and not responded with the previous therapy
- •Cirrhosis
- •Not previously enrolled in any trial of Sofosbuvir
排除标准
- •Not given informed consent
- •Pregnancy
研究组 & 干预措施
treatment
Sofosbuvir, 400 mg OD for 6 months
干预措施: Sofosbuvir (Drug)
结局指标
主要结局
Sustained Viralogical response (SVR)
时间窗: 12 or 24 weeks after discontinuation of therapy
HCV RNA LLQ \< 10 IU/Ml
次要结局
- Viral break through and relapse after discontinuation(Time duration: Up to 12 or 24 weeks)
- Level of (Hepatitis C Virus) HCV RNA(within 12 or 24 weeks from baseline)