Management of Patients With Hepatitis C in a Public Health Care Setting: The Punjab Model
2019年6月13日 更新者:Radha K Dhiman、Postgraduate Institute of Medical Education and Research
Efficacy of Decentralized Care in the Management of Patients With Hepatitis C in a Public Health Care Setting: The Punjab Model
Background and Aims: The prevalence of hepatitis C virus infection (HCV) infection in Punjab, India is 3.29%, with an estimated burden of around 650,000 viremic chronic HCV (CHC) patients.
The Mukh Mantri Punjab Hepatitis C Relief Fund (MMPHCRF) was launched in June 2016 to provide free treatment to all CHC aiming to eliminate HCV from Punjab.
The study assessed the feasibility of decentralized care and efficacy and safety of 12 or 24 weeks of sofosbuvir (SOF) + ledipasvir (LDV) or SOF + daclatasvir (DCV) ± ribavirin (RBV) in the treatment of CHC patients in a public health care setting.
研究概览
详细说明
An algorithm was developed using SOF-based regimens to treat all patients (RKD).
Genotyping is not recommended for patients without cirrhosis of liver and they are being treated with SOF+DCV for 12-weeks, while genotyping is recommended for patients with cirrhosis of liver (Figure 1).
Patients with liver cirrhosis and genotype 3 are being treated with SOF+DCV+RBV for 24 weeks, while non-genotype 3 patients are being treated with SOF+LDV+RBV for 12-weeks or with SOF+LDV for 24-weeks (in RBV intolerant patients).
SVR-12 is mandatory in all patients.
Methods: Decentralized care: All patients are being evaluated and treated at 3 Government Medical Colleges and 22 District Hospitals; they were followed up to 12 weeks post-treatment to look for sustained viral response (SVR-12).
Health care worker capacity building: 90 medical specialists were trained in a 4-hr predefined course, followed by online continued medical education sessions by regular Extension for Community Healthcare Outcomes (ECHO) Clinic are being conducted fortnightly.
50 pharmacists, 2 from each of the 25 centres, dispense medicine as per specialist prescription.
Data Management: 25 trained data entry operators and Clinton Health Access Initiative (CHAI) are managing epidemiological data on CHC hotspots, high-risk groups, local service providers, etc. Monitoring: Medical alerts are being used for compliance monitoring.
Study design: A cost-effective algorithm has been developed using SOF-based regimens to treat all patients.
The diagnosis of cirrhosis is based on clinical evidence including Aspartate Transaminase (AST)-to-platelet ratio index (APRI ≥ 2.0) and FIB-4 score (>3.25) or on liver stiffness measurement (LSM) ≥12.5 kilopascal (kPa) on fibroscan.
The study aims to validate the efficacy and safety of generic all oral Direct Acting Antiviral (DAA) regimens in a decentralized algorithm based public health model in Punjab, India regardless of genotype/presence of cirrhosis.
研究类型
介入性
注册 (预期的)
50000
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Chandigarh、印度、160012
- 招聘中
- Post Graduate Institute of Medical Education and Research
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接触:
- Radha K Dhiman, DM
- 电话号码:911722756335
- 邮箱:rkpsdhiman@hotmail.com
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Chronic Hepatitis C
- Age: >18 years
Exclusion Criteria:
- Chronic liver disease of a non-HCV etiology
- Serum Creatinine >1.5 mg/dl
- Evidence of hepatocellular carcinoma or other malignancy
- Significant cardiovascular, pulmonary, or neurological disease
- History of solid organ or bone marrow transplantation.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他:DAA arm
Direct Acting Antivirals therapy An algorithm was developed using DAA (Sofosbuvir-based regimens to treat all patients (RKD). Non Cirrhotics: Sofosbuvir (SOF)+ Daclatasvir (DCV) for 12-weeks Cirrhotics: Genotype 3 were treated with SOF+DCV+ ribavirin (RBV) for 24 weeks, Non-Genotype 3 patients were treated with SOF+LDV+RBV for 12-weeks or with SOF+LDV for 24-weeks (in RBV intolerant patients). |
DAAs given in patients with viremic chronic hepatitis C
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Sustained Virological Response
大体时间:Up to study completion ( average 12 -24 weeks after therapy)
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HCV RNA Load undetectable
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Up to study completion ( average 12 -24 weeks after therapy)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Serious adverse effects
大体时间:Up to study completion ( average 12 -24 weeks after therapy)
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Assessment of drug related adverse effects, clinical events, decompensation of liver disease
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Up to study completion ( average 12 -24 weeks after therapy)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年6月18日
初级完成 (预期的)
2020年12月1日
研究完成 (预期的)
2020年12月1日
研究注册日期
首次提交
2018年3月22日
首先提交符合 QC 标准的
2018年3月28日
首次发布 (实际的)
2018年4月5日
研究记录更新
最后更新发布 (实际的)
2019年6月14日
上次提交的符合 QC 标准的更新
2019年6月13日
最后验证
2019年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- IEC/2018/000324
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
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