NCT01239706Unknown2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
NTx 265
Experimental
干预措施: NTx 265 (Drug)
结局指标
主要结局
Safety
时间窗: 6 months
The primary endpoint for this study is safety. The following safety endpoints will be assessed: * Type, incidence, severity, timing, seriousness, and relatedness of adverse events. * Lower extremity deep vein ultrasound will be performed to identify and localize deep or superficial venous thrombosis. * Vital signs * Laboratory assessments. Particular attention will be paid to serial hemoglobin and hematocrit measurements. * DVT, PE, thromboembolism, MI and stroke.
次要结局
- Efficacy(6 months)
研究者
研究点 (1)
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