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

November 10, 2010 updated by: University of Calgary

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N2T9
        • Recruiting
        • Foothills Medical Center
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 6 months

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: 6 months

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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Calgary

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Stem Cell Therapeutics Corp.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David A Zygun, MD, MSc, University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2010

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2012

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 11, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 11, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23036

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Traumatic Brain Injury

Clinical Trials on NTx 265

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings