Eliminating Hepatitis C Virus
2021年3月23日 更新者：Andrea Branch、Icahn School of Medicine at Mount Sinai
Curing HCV at Mount Sinai in Patients at High Risk for Disease Progression: HIV/HCV Co-infection and Type 2 Diabetes, New Solutions to the Challenge of Eliminating HCV
Initially, HCV Informatics (C-IT) will be used to filter the EMR data of the one million people who receive care at Mount Sinai and identify candidates for HCV testing (baby boomers, patients with HIV infection) and candidates for HCV treatment (patients with positive test results for HCV RNA and no record of treatment).once
treatment candidates have been identified through this proactive approach, their providers will be directly notified.
HCV champions and patient navigators will be used to further lower barriers to the delivery of HCV care.
They will be co-located at non-hepatology care sites and will help deliver open-label HCV treatment as part of standard medical care to 500 HIV/HCV co-infected patients and 200 patients with type 2 diabetes.
研究概览
研究类型
观察性的
注册 (实际的)
52
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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New York
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New York、New York、美国、10029
- Icahn School of Medicine at Mount Sinai
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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
不适用
有资格学习的性别
全部
取样方法
非概率样本
研究人群
People who receive care at Mount Sinai and candidates for HCV testing or HCV treatment and co-located at non-hepatology care sites.
描述
Inclusion Criteria:
Inclusion criteria for HCV treatment in patients with HIV/HCV co-infection
- 18 years of age or older
- HCV RNA positive
- Any HCV genotype
- Documented infection with HIV, with the following additional criteria: - Patients on HAART should be on a stable regimen for 4 weeks, with a CD4 count > 100, and an HIV viral load < 50 prior to initiation of HCV therapy Patients not on HAART should have a CD4 count > 350
- Expected life expectancy sufficient to receive a benefit from HCV cure
- No conditions that are contraindications for the use of HCV medications
Inclusion criteria for HCV treatment in patients with type 2 diabetes
- 18 years of age or older
- HCV RNA positive
- Any HCV genotype
- Documented diagnosis of type 2 diabetes, confirmed by medical record review by the study endocrinologist, Dr. Sherley Abraham
- Expected life expectancy sufficient to receive a benefit from HCV cure
Exclusion Criteria:
- No conditions that are contraindications for the use of HCV medications
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
队列和干预
团体/队列 |
|---|
|
HIV/HCV Co-infected
Patients with HIV/HCV co-infection
|
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Type 2 Diabetes
Patients with Type 2 Diabetes
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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 |
|---|---|---|
|
Change in the Number of Patients with sCD163 above the upper limit of normal
大体时间：baseline and 3 years
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Change in the Number of Patients with sCD163 above the upper limit of normal at 3 years from baseline
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baseline and 3 years
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Number of Type 2 Diabetes patients that initiate HCV treatment
大体时间：3 years
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The number of patients that initiate HCV treatment per month per patient navigator.
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3 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
sCD163
大体时间：3 years
|
blood sample for sC163, a marker of systemic inflammation.
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3 years
|
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Percentage of patients in need of repeated re-treatment
大体时间：3 years
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The percentage of patients in need of repeated re-treatment whose quasispecies analysis indicates that re-infection is the likely cause of recurrent HCV viremia.
If such patients are identified, they will be referred for risk reduction counseling.
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3 years
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HOMA-IR
大体时间：3 years
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Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).
Healthy Range: 1.0 (0.5-1.4) Less than 1.0 means insulin-sensitive which is optimal.
Above 1.9 indicates early insulin resistance.
Above 2.9 indicates significant insulin resistance.
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3 years
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Number of resistance associated variant (RAV)
大体时间：3 years
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Resistance associated variant (RAV) testing from up to 50 patients who fail treatment or become re-infected
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3 years
|
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FIB-4 score
大体时间：3 years
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The FIB-4 score of HCV positive patients with type 2 diabetes.
The Fibrosis 4 score is a non-invasive scoring system based on several laboratory tests that help to estimate the amount of scarring in the liver.
This score has been studied in liver disease due to Hepatitis C and NASH.
Formula : ( Age x AST ) / ( Platelets x ( sqr ( ALT )
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3 years
|
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HCV cure rate
大体时间：3 years
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The HCV cure rate among patients with type 2 diabetes
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3 years
|
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。
调查人员
- 首席研究员：Andrea D. Branch, PhD、Icahn School of Medicine at Mount Sinia
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)
2018年1月23日
初级完成 (实际的)
2021年3月1日
研究完成 (实际的)
2021年3月1日
研究注册日期
首次提交
2018年1月9日
首先提交符合 QC 标准的
2018年1月16日
首次发布 (实际的)
2018年1月17日
研究记录更新
最后更新发布 (实际的)
2021年3月24日
上次提交的符合 QC 标准的更新
2021年3月23日
最后验证
2021年3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
- GCO 17-1070
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Direct outreach to providers (giving them the names of their patients who are candidates for treatment)
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
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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Meir Medical Center完全的开发从数字立体光盘图像测量 C/D 比的新技术 | C/D 测量的观察者内再现性 | C/D 测量的观察者间变异性
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University Hospital, GrenobleClinical Investigation Centre for Innovative Technology Network完全的
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Haisco Pharmaceutical Group Co., Ltd.完全的