Status:
UNKNOWN
Safety Study of Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Traumatic Brain Injury: Dosing Tier 1
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Stem Cell Therapeutics Corp.
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 fo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01239706
Start Date
November 1 2010
End Date
June 1 2012
Last Update
November 11 2010
Active Locations (1)
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1
Foothills Medical Center
Calgary, Alberta, Canada, T2N2T9