Safety Study of Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Traumatic Brain Injury: Dosing Tier 1
NCT ID: NCT01239706
Last Updated: 2010-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
10 participants
INTERVENTIONAL
2010-11-30
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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NTx 265
NTx 265
10,000IU of hCG, every other day for three doses followed by 4000IU once daily for three days of erythropoietin
Interventions
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NTx 265
10,000IU of hCG, every other day for three doses followed by 4000IU once daily for three days of erythropoietin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Written and informed consent from a legally acceptable representative
3. Moderate to severe traumatic brain injury (TBI) defined as Glasgow Coma motor (GCSm) score ≤5, post resuscitation.
4. Patient is \<48hours from time of injury when the first dose of NTx™-265 is administered.
5. Reasonable expectation of availability to receive the full 9 day course of therapy and be available for follow up evaluations
6. Female patient is either:
1. Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral oophorectomy or hysterectomy) or
2. 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
2. Bilaterally fixed pupils
3. Serum hemoglobin \>160g/L (males) or \>140g/L (female); or platelet count \> 400,000/mm3
4. Advanced cardiac, pulmonary, hepatic or liver disease; the former will be operationally defined using NCI Toxicity Criteria (Grade 2 or higher).
5. Suspected anoxic or ischemic brain injury
6. Known endocrine or germ cell tumor
7. Serum billirubin \> 1.5 x upper limit of normal (ULN).
8. Alkaline Phosphatase \> 2.5 x ULN
9. AST and/or ALT \> 2.5 x ULN
10. Creatinine \> 2.0 x ULN
11. Patients with known or documented transferrin saturation \< 20% or ferritin \< 100ng/mL.
12. Male patients with known and documented elevated PSA levels, or a PSA level of ≥4ng/mL at screening.
13. Patients with known history or hypercoagulability, including known cardiolipin/antiphospholipid antibody syndrome.
14. Allergy or other contraindication to hCG including:
1. Prior hypersensitivity to hCG preparations or one of their excipients.
2. Primary ovarian failure.
3. Uncontrolled thyroid or adrenal dysfunction.
4. An uncontrolled organic intracranial lesion such as a pituitary tumor.
5. Abnormal uterine bleeding of undetermined origin.
6. Ovarian cyst or ovarian enlargement of undetermined origin.
7. Sex hormone dependent tumors of the reproductive organs, accessory sex glands, and breasts.
15. Allergy or other contraindication to epoetin alfa:
1. Who developed pure red cell aplasia following treatment with any erythropoiesis regulating hormones.
2. With uncontrolled hypertension
3. With known hypersensitivity to mammalian cell-derived products, albumin (human) or any component of the product
4. Who for any reason cannot receive adequate antithrombotic treatment
16. A known diagnosis of cancer (except basal cell cancer).
17. Uncontrolled hypertension, defined 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. 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.
21. Any other medical condition, in the investigator's opinion, the patient should not be included in the trial.
22. Patients who cannot take anti-platelet or anti-coagulant therapy.
23. Pre-existing and active major psychiatric or other chronic Neurological disease.
24. Patients who have a history of substance abuse or dependency within 12 months prior to the study.
25. Currently participating in another investigational study
26. Polytrauma defined as an Abbreviated Injury Severity Score \>3 in any area other than head.
27. Patients with evidence of an active or previous thrombotic event.
28. Patients with contraindications to MRI scans
29. Patients who are currently taking hormonal based contraceptives or hormonal replacement therapy in the past three (3) months.
18 Years
65 Years
ALL
No
Sponsors
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Stem Cell Therapeutics Corp.
INDUSTRY
University of Calgary
OTHER
Responsible Party
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University of Calgary
Principal Investigators
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David A Zygun, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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Foothills Medical Center
Calgary, Alberta, Canada
Countries
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Central Contacts
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Facility Contacts
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Stephanie Todd, BSc, MBT, CCRP
Role: primary
Other Identifiers
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23036
Identifier Type: -
Identifier Source: org_study_id