CTRI/2008/091/000262未知2 期
A Phase IIb prospective, randomized, double-blind, placebo controlled study of NTxTM-265: human chorionic gonadotropin (hCG) and epoetin alfa (EPO) in acute ischemic stroke patients (REGENESIS)
试验速览
- 阶段
- 2 期
- 试验地点
- 10
- 主要终点
- Modified Rankin Score (mRS)NIHSS response
研究概览
简要总结
The proposed study is a phase IIb, multi-center, randomized, double-blind placebo controlled study. It is being conducted at multiple sites in Canada, USA and India. In India, the study is proposed to be conducted at ten (10) investigative sites to recruit approximately 60 patients. The purpose of this study is to determine the safety and efficacy of the NTx- 265 (Human Chorionic Gonadotropin and Epoetin alfa) therapy in acute ischemic stroke patients over placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •NIHSS score 6-24 within 24-48 hours after stroke onset and enrolment.
- •Stroke is ischemic in origin, supratentorial, and radiologically confirmed (CT scan or diagnostic MRI) prior to enrolment.
- •MRI is mandatory for patients included in the MRI sub-study.
- •Patient is 24-48 hours from time of stroke onset when the first dose of NTxTM-265 therapy is administered.
- •Time of onset is when symptoms began; for stroke that occurred during sleep, time of onset is when patient was last seen or was self-reported to be normal.
- •Reasonable expectation of availability to receive the full 9 day NTxTM-265 course of therapy, and to be available for subsequent follow-up visits.
- •Reasonable expectation that patient will receive standard post-stroke physical, occupational, speech, and cognitive therapy as indicated.
- •Female patient is either: a.
- •Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or, b.
- •Condoms, sponge, foams, jellies, diaphragm or intrauterine device, contraceptives (e.g., implants, injectables, combined oral, etc) OR ?
- •A vasectomised partner OR ?
- •Abstinence.
排除标准
- •Patients presenting with lacunar, hemorrhagic and/or brain stem stroke
- •Patients classified as comatose, defined as a patient who required repeated stimulation to attend, or is obtunded and requires strong or painful stimulation to make movements (NIHSS 1A score must be <2).
- •Women who have 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.
- •Serum hemoglobin > 16 g/dL (males) or > 14 g/dL (females).
- •Alkaline phosphatase > 2.5 x ULN
- •AST > 2.5 x ULN, ALT > 2.5 x ULN
- •Creatinine > 2.0 x ULN
- •Patients with known and documented transferrin saturation < 20%.
- •Patients with known and documented Ferritin < 100 ng/mL.
- •Patients with known and documented elevated PSA levels, or a PSA level of ≥ 4 ng/mL at screening.
- •Patients with a known history of hypercoagulability, including known cardiolipin / antiphospholipid antibody syndrome.
- •Expected survival < 1 year.
- •Allergy or other contraindication to hCG including:a.
- •Prior hypersensitivity to hCG preparations or one of their excipients.b. Primary ovarian failure.c. Uncontrolled thyroid or adrenal dysfunction.d. An uncontrolled organic intracranial lesion such as a pituitary tumor.e. Abnormal uterine bleeding of undetermined originf.
- •Ovarian cyst or ovarian enlargement of undetermined origing.
- •Sex hormone dependent tumors of the reproductive organs, accessory sex glands, and breasts
- •Allergy or other contraindication to epoetin alfa.a. Who developed pure red cell aplasia following treatment with any erythropoiesis regulating hormonesb.
- •With uncontrolled hypertension c.
- •With known hypersensitivity to mammalian cell-derived products, albumin (human) or any component of the product d.
- •Who for any reason cannot receive adequate antithrombotic treatment
- •A known diagnosis of cancer (except non-malignant skin cancer).
- •Uncontrolled hypertension, defined in the context of acute stroke as blood pressure persistently above 220 mm Hg systolic or 120 mm Hg diastolic despite antihypertensive therapy.
- •Any condition known to elevate hCG, active in the prior 24 months, e.g., choriocarcinoma or germ cell tumor.
- •Patients with a pre-stroke/pre-morbid modified Rankin Score (mRS) ≥
- •Any patients living in a nursing home or supervised living center.
- •Any other medical condition or degree of stroke such that, in the investigator?s opinion, the patient should not be included in the trial.
- •With the exception of the qualifying stroke, any other stroke within the previous 6 months.
- •Patients who cannot take anti-platelet or anti-coagulant therapy.
- •Pre-existing and active major psychiatric or other chronic neurological disease.
- •Consume, on average, greater than 14 alcoholic drinks per week, or have a history of substance abuse or dependency within 12 months prior to the study.
- •Currently participating in another investigational study.
结局指标
主要结局
Modified Rankin Score (mRS)NIHSS response
时间窗: Day 90
次要结局
- NIHSSmRSBarthel Index Action Research Arm Test Gait Velocity Test Boston Naming Test Line Cancellation Test Trails A & B Test(Day 90)
研究者
研究点 (10)
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