Impact of Hepatitis C Therapy and Bone Health (HCV)
Impact of HCV Therapy on Cardiovascular Risk and Bone Health
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
Texas
-
Dallas、Texas、美国、75216
- Dallas VA Medical Center
-
-
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:
- HCV antibody and HCV RNA positive
- HCV Genotype 1a, 1b, or 4
Liver staging assessment:
a. Cirrhosis will be defined by any of the following: i. A liver biopsy prior to day 1 of this study showing cirrhosis (F4) ii. Fibroscan within 12 calendar months of day 1 of this study showing cirrhosis with result > 12.5 kPa iii. FibroSURE performed during screening with a score > 0.75 and APRI > 2 b. Absence of cirrhosis will be defined by any of the following: i. Liver biopsy performed within 24 months of day 1 of this study showing absence of cirrhosis ii. Fibroscan performed within 12 months of day 1 of this study with a result of ≤ 12.5 kPa iii. FibroSURE score ≤ 0.48 and APRI ≤ 1 during screening
If HIV co-infected, HAART regimen will consist of two NRTIs (abacavir, tenofovir disoproxil fumarate or tenofovir alafenamide, each in combination with lamivudine or emtricitabine) with one of the following 3rd agents:
- raltegravir
- dolutegravir
- rilpivirine HIV co-infected patients must be on their stable HAART regimen for at least 6 months, with HIV viral load < 50 c/mL at screening
Exclusion Criteria:
- Hepatitis B surface antigen positivity
- Decompensated cirrhosis (Child Pugh B or C)
- Any prior hepatitis C treatment
- Pregnant or nursing
- Treatment with any medication specifically contraindicated with EBR/GZR or not recommended for concomitant use as per the prescribing label (Table 2)
- Age less than 18
- Prisoners or subjects otherwise involuntarily incarcerated
- Absence of signed informed consent by patient or appropriate surrogate
- Known hypersensitivity to elbasvir or grazoprevir
- For patients with genotype 1a, one more of the following mutations on baseline NS5A genotype: M28, Q30, L31, or Y93
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:并行分配
- 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:EBR/GZR (Zepatier) - HCV/HIV co-infected
Drug: Elbasvir (EBR) 50 mg and Grazoprevir (GZR) 100 mg single tablet by mouth, once daily.
|
Elbasvir and Grazoprevir (EBR/GZR) tablet by mouth, once daily.
其他名称:
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实验性的:EBR/GZR (Zepatier) - HCV monoinfected
Drug: Elbasvir (EBR) 50 mg and Grazoprevir (GZR) 100 mg single tablet by mouth, once daily.
|
Elbasvir and Grazoprevir (EBR/GZR) tablet by mouth, once daily.
其他名称:
|
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 |
---|---|---|
Evaluate the impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HCV mono-infected patients and HIV/HCV co-infected patients
大体时间:48 weeks
|
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, positron emission tomography (PET) scanning for arterial inflammation, coronary calcification and myocardial viability.
|
48 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HCV mono-infected patients.
大体时间:Biomarkers of inflammation and bone turnover measured at week 0 of therapy.
|
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability.
Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by dual energy x-ray absorptiometry (DXA) scan and trabecular bone score (TBS).
|
Biomarkers of inflammation and bone turnover measured at week 0 of therapy.
|
Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HCV mono-infected patients.
大体时间:Bone mineral density measured at week 0 of therapy
|
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability.
Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
|
Bone mineral density measured at week 0 of therapy
|
Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HCV mono-infected patients.
大体时间:Biomarkers of inflammation and bone turnover measured at week 12 of therapy.
|
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability.
Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
|
Biomarkers of inflammation and bone turnover measured at week 12 of therapy.
|
Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HCV mono-infected patients.
大体时间:Biomarkers of inflammation and bone turnover measured at week 24 of therapy.
|
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability.
Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
|
Biomarkers of inflammation and bone turnover measured at week 24 of therapy.
|
Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HCV mono-infected patients.
大体时间:Bone mineral density measured at week 48 of therapy.
|
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability.
Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
|
Bone mineral density measured at week 48 of therapy.
|
Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HIV/HCV co-infected patients.
大体时间:Biomarkers of inflammation and bone turnover measured at week 0 of therapy.
|
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability.
Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
|
Biomarkers of inflammation and bone turnover measured at week 0 of therapy.
|
Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HIV/HCV co-infected patients.
大体时间:Bone mineral density measured at week 0 of therapy
|
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability.
Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
|
Bone mineral density measured at week 0 of therapy
|
Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HIV/HCV co-infected patients.
大体时间:Biomarkers of inflammation and bone turnover measured at week 12 of therapy.
|
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability.
Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
|
Biomarkers of inflammation and bone turnover measured at week 12 of therapy.
|
Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HIV/HCV co-infected patients.
大体时间:Biomarkers of inflammation and bone turnover measured at week 24 of therapy.
|
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability.
Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
|
Biomarkers of inflammation and bone turnover measured at week 24 of therapy.
|
Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HIV/HCV co-infected patients.
大体时间:Biomarkers of inflammation and bone turnover measured at week 48 of therapy.
|
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability.
Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
|
Biomarkers of inflammation and bone turnover measured at week 48 of therapy.
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
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
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- MISP 54850
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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