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

NCT01239706 | Unknown Phase 2 DMC

• 1 other identifier: 23036
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 followed for an additional 6 months.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Safety

  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.

  6 months

Secondary Outcomes (1)

• Efficacy

  6 months

Study Arms (1)

NTx 265

EXPERIMENTAL

Drug: NTx 265

Interventions

NTx 265 DRUG

10,000IU of hCG, every other day for three doses followed by 4000IU once daily for three days of erythropoietin

Also known as: Eprex, Ortho Biotech, Ovidrel, Serono

NTx 265

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead
• Stem Cell Therapeutics Corp.: collaborator

Study Sites (1)

Foothills Medical Center

Calgary, Alberta, T2N2T9, Canada

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Epoetin Alfa; Ovidrel

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• David A Zygun, MD, MSc

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Zygun, MD

CONTACT

403-944-1691; dzygun@ucalgary.ca

Stephanie Todd, BSc, MBT, CCRP

CONTACT

403-944-3414; stephanie.todd@albertahealthservices.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 10, 2010
• First Posted: November 11, 2010
• Study Start: November 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 11, 2010

Record last verified: 2010-02

Locations

CA (1)