Safety Study of Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Traumatic Brain Injury: Dosing Tier 1

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by University of Calgary.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Stem Cell Theraputics
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT01239706
First received: November 10, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Traumatic Brain Injury
Drug: NTx 265
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    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.


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    The following secondary endpoints will also be assessed in order to measure various aspects of neurological status:

    • GOSE at hospital discharge, 3, and 6 months post-TBI
    • Neurobehavioral Rating Score at hospital discharge, 3, and 6 months post TBI
    • Disability Rating Score at hospital discharge, 3, and 6 months post TBI


Estimated Enrollment: 10
Study Start Date: November 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NTx 265 Drug: NTx 265
10,000IU of hCG, every other day for three doses followed by 4000IU once daily for three days of erythropoietin
Other Names:
  • Eprex, Ortho Biotech
  • Ovidrel, Serono

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female patients age 18-65
  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:

  1. 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.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01239706

Contacts
Contact: David Zygun, MD 403-944-1691 dzygun@ucalgary.ca
Contact: Stephanie Todd, BSc, MBT, CCRP 403-944-3414 stephanie.todd@albertahealthservices.ca

Locations
Canada, Alberta
Foothills Medical Center Recruiting
Calgary, Alberta, Canada, T2N2T9
Contact: Stephanie Todd, BSc, MBT, CCRP    403-944-3414    stephanie.todd@albertahealthservices.ca   
Principal Investigator: David A Zygun, MD, MSc,         
Sub-Investigator: Andreas Kramer, MD, MSc         
Sub-Investigator: Clare Gallagher, MD, PhD         
Sub-Investigator: James Scott, MD, MSc         
Sponsors and Collaborators
University of Calgary
Stem Cell Theraputics
Investigators
Principal Investigator: David A Zygun, MD, MSc University of Calgary
  More Information

No publications provided

Responsible Party: Dr. David A Zygun, University of Calgary
ClinicalTrials.gov Identifier: NCT01239706     History of Changes
Other Study ID Numbers: 23036
Study First Received: November 10, 2010
Last Updated: November 10, 2010
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Epoetin alfa
Chorionic Gonadotropin
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014