Safety Study of Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Traumatic Brain Injury: Dosing Tier 1
2010年11月10日 更新者:University of Calgary
A Phase IIa, Single Centre, Open Label Study to Characterize the Safety of Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Traumatic Brain Injury: Dosing Tier 1
Prospective, Open Label, Cohort Study in Traumatic Brain Injury Patients.
The goal of this study is to assess the safety of NTx®-265.
NTx®-265 will be administered over 9 days, and patients will be followed for an additional 6 months.
研究概览
研究类型
介入性
注册 (预期的)
10
阶段
- 阶段2
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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Alberta
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Calgary、Alberta、加拿大、T2N2T9
- 招聘中
- Foothills Medical Center
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接触:
- Stephanie Todd, BSc, MBT, CCRP
- 电话号码:403-944-3414
- 邮箱:stephanie.todd@albertahealthservices.ca
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首席研究员:
- David A Zygun, MD, MSc,
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副研究员:
- Andreas Kramer, MD, MSc
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副研究员:
- Clare Gallagher, MD, PhD
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副研究员:
- James Scott, MD, MSc
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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 至 65年 (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:
- Male and female patients age 18-65
- Written and informed consent from a legally acceptable representative
- Moderate to severe traumatic brain injury (TBI) defined as Glasgow Coma motor (GCSm) score ≤5, post resuscitation.
- Patient is <48hours from time of injury when the first dose of NTx™-265 is administered.
- Reasonable expectation of availability to receive the full 9 day course of therapy and be available for follow up evaluations
Female patient is either:
- Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral oophorectomy or hysterectomy) or
If of childbearing potential, would agree to use two of the following reliable methods of birth control throughout the study, including the follow-up visits:
- Condoms, sponge, foams, jellies, diaphragm or intrauterine device
- A vasectomised partner
- Abstinence
- Note: Hormonal Based contraceptives are NOT permissible as one of the two forms of contraceptives for this study.
Exclusion Criteria:
- Women who have been tested positive for pregnancy, or are breast-feeding or are not using a highly effective method of birth control that can be maintained for the duration of the study.
- Bilaterally fixed pupils
- Serum hemoglobin >160g/L (males) or >140g/L (female); or platelet count > 400,000/mm3
- Advanced cardiac, pulmonary, hepatic or liver disease; the former will be operationally defined using NCI Toxicity Criteria (Grade 2 or higher).
- Suspected anoxic or ischemic brain injury
- Known endocrine or germ cell tumor
- Serum billirubin > 1.5 x upper limit of normal (ULN).
- Alkaline Phosphatase > 2.5 x ULN
- AST and/or ALT > 2.5 x ULN
- Creatinine > 2.0 x ULN
- Patients with known or documented transferrin saturation < 20% or ferritin < 100ng/mL.
- Male patients with known and documented elevated PSA levels, or a PSA level of ≥4ng/mL at screening.
- Patients with known history or hypercoagulability, including known cardiolipin/antiphospholipid antibody syndrome.
Allergy or other contraindication to hCG including:
- Prior hypersensitivity to hCG preparations or one of their excipients.
- Primary ovarian failure.
- Uncontrolled thyroid or adrenal dysfunction.
- An uncontrolled organic intracranial lesion such as a pituitary tumor.
- Abnormal uterine bleeding of undetermined origin.
- Ovarian cyst or ovarian enlargement of undetermined origin.
- Sex hormone dependent tumors of the reproductive organs, accessory sex glands, and breasts.
Allergy or other contraindication to epoetin alfa:
- Who developed pure red cell aplasia following treatment with any erythropoiesis regulating hormones.
- With uncontrolled hypertension
- With known hypersensitivity to mammalian cell-derived products, albumin (human) or any component of the product
- Who for any reason cannot receive adequate antithrombotic treatment
- A known diagnosis of cancer (except basal cell cancer).
- Uncontrolled hypertension, defined as blood pressure persistently above 220 mm Hg systolic or 120 mm Hg diastolic despite antihypertensive therapy.
- Use of either hCG or epoetin alfa within the previous 90 days.
- Any condition known to elevate hCG, active in the prior 24 months e.g., choriocarcinoma or germ cell tumor.
- Any patients living in a nursing home or supervised living center. Patients must be historically fully independent in all activities of daily living including banking, shopping, cooking, toileting, showering and dressing.
- Any other medical condition, in the investigator's opinion, the patient should not be included in the trial.
- Patients who cannot take anti-platelet or anti-coagulant therapy.
- Pre-existing and active major psychiatric or other chronic Neurological disease.
- Patients who have a history of substance abuse or dependency within 12 months prior to the study.
- Currently participating in another investigational study
- Polytrauma defined as an Abbreviated Injury Severity Score >3 in any area other than head.
- Patients with evidence of an active or previous thrombotic event.
- Patients with contraindications to MRI scans
- Patients who are currently taking hormonal based contraceptives or hormonal replacement therapy in the past three (3) months.
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: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 |
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实验性的:NTx 265
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10,000IU of hCG, every other day for three doses followed by 4000IU once daily for three days of erythropoietin
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 |
---|---|---|
Safety
大体时间:6 months
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The primary endpoint for this study is safety. The following safety endpoints will be assessed:
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Efficacy
大体时间:6 months
|
The following secondary endpoints will also be assessed in order to measure various aspects of neurological status:
|
6 months
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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。
调查人员
- 首席研究员:David A Zygun, MD, MSc、University of Calgary
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
2010年11月1日
初级完成 (预期的)
2012年6月1日
研究完成 (预期的)
2012年6月1日
研究注册日期
首次提交
2010年11月10日
首先提交符合 QC 标准的
2010年11月10日
首次发布 (估计)
2010年11月11日
研究记录更新
最后更新发布 (估计)
2010年11月11日
上次提交的符合 QC 标准的更新
2010年11月10日
最后验证
2010年2月1日
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.
NTx 265的临床试验
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Stem Cell Therapeutics Corp.撤销
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Novartis Pharmaceuticals完全的
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Major Extremity Trauma Research ConsortiumUnited States Department of Defense招聘中