CTRI/2008/091/000262Other2 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
- 状态
- Other
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Age 18-85.
- •2. NIHSS score 6-24 within 24-48 hours after stroke onset and enrolment.
- •3. 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.
- •4. 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.
- •5. Reasonable expectation of availability to receive the full 9 day NTxTM-265 course of therapy, and to be available for subsequent follow-up visits.
- •6. Reasonable expectation that patient will receive standard post-stroke physical, occupational, speech, and cognitive therapy as indicated.
- •7. 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. If of childbearing potential, agrees to use two of the following effective separate forms of contraception throughout the study, up to and including the follow-up visits:
- •? Condoms, sponge, foams, jellies, diaphragm or intrauterine device, contraceptives (e.g., implants, injectables, combined oral, etc)
- •? A vasectomised partner
- •? Abstinence
排除标准
- •1. Patients presenting with lacunar, hemorrhagic and/or brain stem stroke
- •2. 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).
- •3. 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.
- •4. Serum hemoglobin > 16 g/dL (males) or > 14 g/dL (females). Platelet count > 400,000/mm3.
- •5. Advanced liver, kidney, cardiac and/or pulmonary disease; the former will be operationally defined using NCI Toxicity Criteria (Grade 2 or higher): Appendix II
- •6. Serum bilirubin > 1.5 x upper limit of normal (ULN)
- •7. Alkaline phosphatase > 2.5 x ULN
- •8. AST > 2.5 x ULN, ALT > 2.5 x ULN
- •9. Creatinine > 2.0 x ULN
- •10. Patients with known and documented transferrin saturation < 20%. Patients with known and documented Ferritin < 100 ng/mL.
- •11. Patients with known and documented elevated PSA levels, or a PSA level of ≥ 4 ng/mL at screening.
- •12. Patients with a known history of hypercoagulability, including known cardiolipin / antiphospholipid antibody syndrome.
- •13. Expected survival < 1 year.
- •14. 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 origin
- •f. Ovarian cyst or ovarian enlargement of undetermined origin
- •g. Sex hormone dependent tumors of the reproductive organs, accessory sex glands, and breasts
- •15. Allergy or other contraindication to epoetin alfa.
- •a. Who developed pure red cell aplasia following treatment with any erythropoiesis regulating hormones
- •b. 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
- •16. A known diagnosis of cancer (except non-malignant skin cancer).
- •17. 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.
- •18. Use of either hCG or epoetin alfa within the previous 90 days.
- •19. Any condition known to elevate hCG, active in the prior 24 months, e.g., choriocarcinoma or germ cell tumor.
- •20. Patients with a pre-stroke/pre-morbid modified Rankin Score (mRS) ≥ 2.
- •21. 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.
- •22. Any other medical condition or degree of stroke such that, in the investigator?s opinion, the patient should not be included in the trial.
- •23. With the exception of the qualifying stroke, any other stroke within the previous 6 months.
- •24. Patients who cannot take anti-platelet or anti-coagulant therapy.
- •25. Pre-existing and active major psychiatric or other chronic neurological disease.
- •26. Consume, on average, greater than 14 alcoholic drinks per week, or have a history of substance abuse or dependen
研究者
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