Toward Elimination of Hepatitis C Virus (HCV): A Pilot Study (ELIMINATEC)
Toward Elimination of Hepatitis C Virus (HCV): A Pilot Study Combining HCV and Addiction Treatment of Young Suburban Heroin Users (SHU) That Addresses Barriers to Care
研究概览
详细说明
To demonstrate that colocation treatment of substance use disorder and Hepatitis C infection concurrently while proving addiction counselling will achieve increased duration of sobriety and elimination of Hepatitis C virus in study participants.
Primary objective:
1. Cure rates (SVR-12, HCV plasma RNA not quantifiable 12 weeks after last dose of treatment) of HCV in 30 recently identified PWIDS under 30 years old
Secondary objectives:
- Rate of sobriety maintenance for 1 year after enrollment
- Re-infection rate with HCV over 1 year after enrollment
- Re-admission rates for detox
- Cravings
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名:Ronald Nahass, MD
- 电话号码:9082810221
- 邮箱:rnahass@idcare.com
研究联系人备份
- 姓名:Kathleen Seneca, MSN, APN
- 电话号码:9082810221
- 邮箱:kseneca@idcare.com
学习地点
-
-
New Jersey
-
Hillsborough、New Jersey、美国、08844
- ID Care
-
接触:
- Kathleen Seneca, MSN, APN
- 电话号码:9082810221
- 邮箱:kseneca@idcare.com
-
接触:
- Ronald Nahass, MD
- 电话号码:908-281-0221
- 邮箱:rnahass@idcare.com
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 18 - 30
- Successfully detoxed at PHBH from opioids
- Agree to participate in a closely monitored program
- Positive HCV VL > 5,000 on two tests
- Minimum one follow-up visit after discharge from PHBH to be enrolled
- Any genotype
- APRI less than 1 and Fibrosure less than 0.45
- Negative pregnancy test in women and females must agree to acceptable contraception during treatment of HCV. Oral contraceptives that do not contain ethinyl estradiol are allowed with Mavyret
- Treatment naïve for HCV
- Signed informed consent
Exclusion Criteria:
- Cirrhosis
- Co-infection with HIV or HBV
- Inability to comply with treatment or follow up
- Renal failure with GFR less than 50 mL/min5*
- Any prior treatment for HCV
- Diabetes with HgA1c more than 8.0
Clinically significant abnormalities, other than HCV infection, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG) that make the subject an unsuitable candidate for this study in the opinion of the investigator, including, but not limited to:
- ALT/AST > 10x normal value,
- WBC with ANC < 1500 cell/ul,
- Hemoglobin < LLN,
- Treatment for cancer or lymphoma in the past 5 years,
- Hemoglobin A 1C > 8%.
- Any uncontrolled psychiatric, cardiac, respiratory, gastrointestinal, hematologic, neurologic, psychiatric, or other medical disease or disorder, which is unrelated to the existing HCV infection which in the opinion of the PI would prevent adherence to and participation in the trial.
- Hypersensitivity to naltrexone or polylactide-co-glycolide (PLG) microspheres
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 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 |
---|---|
实验性的:Open Label Treatment Arm
Treatment arm using Glecaprevir-pibrentasvir for treatment of all patients
|
Glecaprevir-pibrentasvir will be dispensed to 30 patients recently detoxed off heroin in an acute detox center.
|
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 |
---|---|---|
Cure rate of Hepatitis C Infection
大体时间:12 weeks after treatment completion viral load measure
|
Cure rates (SVR-12, HCV plasma RNA not quantifiable 12 weeks after last dose of treatment) of HCV in 30 recently identified PWIDS under 30 years
|
12 weeks after treatment completion viral load measure
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Sobriety from Drug Use
大体时间:1 year
|
Rate of sobriety maintenance for 1 year after enrollment
|
1 year
|
Hepatitis C Reinfection Rate
大体时间:1 year
|
Re-infection rate with HCV over 1 year after enrollment
|
1 year
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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.
丙型肝炎的临床试验
-
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
-
Haisco Pharmaceutical Group Co., Ltd.完全的
-
University Hospital, GrenobleClinical Investigation Centre for Innovative Technology Network完全的
Glecaprevir-pibrentasvir的临床试验
-
Raymond ChungJohns Hopkins University; University of Pennsylvania; Northwestern University; AbbVie; University... 和其他合作者完全的
-
Kirby Institute完全的
-
AbbVie主动,不招人丙型肝炎病毒 (HCV)美国, 澳大利亚, 奥地利, 加拿大, 法国, 德国, 意大利, 西班牙
-
AbbVie完全的丙型肝炎病毒 (HCV)美国, 比利时, 加拿大, 德国, 日本, 波多黎各, 俄罗斯联邦, 西班牙, 英国
-
AbbVie完全的
-
White River Junction Veterans Affairs Medical Center招聘中