Traumatic Brain InjuryPhase 2NCT01239706
Safety Study of Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Traumatic Brain Injury: Dosing Tier 1
A Phase 2 study testing NTx 265 in people with Traumatic Brain Injury, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- NTx 265
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2010to Jun 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Foothills Medical Center
Calgary, Alberta, T2N2T9
Stephanie Todd, BSc, MBT, CCRP, 403-944-3414, stephanie.todd@albertahealthservices.ca
David A Zygun, MD, MSc,
About this study
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
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
- Being tested
- NTx 265
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTx 265Drug
Also called Eprex, Ortho Biotech, Ovidrel, Serono
10,000IU of hCG, every other day for three doses followed by 4000IU once daily for three days of erythropoietin
| Study group | Role | What they receive |
|---|---|---|
| NTx 265 | Experimental | Not described Receives: Drug: NTx 265 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Efficacy
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Stem Cell Therapeutics Corp.
- Investigators
- David A Zygun, MD, MSc, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239706
- Sponsor's protocol ID
- 23036
- Status last verified
- Feb 2010
- First submitted
- 10 Nov 2010
- Last updated
- 11 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01239706
- Acronym / sponsor ID
- 23036
- Conditions
- Traumatic Brain Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Stem Cell Therapeutics Corp.
- Study start
- Nov 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 11 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NTx 265 | Experimental | Drug: NTx 265 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (40 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NTx 265Also: Eprex, Ortho Biotech, Ovidrel, Serono10,000IU of hCG, every other day for three doses followed by 4000IU once daily for three days of erythropoietin | Drug | NTx 265 |
Primary outcome
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.
1 secondary outcome
Efficacy
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Zygun, MD, MSc principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NTx 265 in people with Traumatic Brain Injury, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Zygun, MD (403-944-1691, dzygun@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2010.