Safety Study of Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Traumatic Brain Injury: Dosing Tier 1
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|ClinicalTrials.gov Identifier: NCT01239706|
Recruitment Status : Unknown
Verified February 2010 by University of Calgary.
Recruitment status was: Recruiting
First Posted : November 11, 2010
Last Update Posted : November 11, 2010
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Drug: NTx 265||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||June 2012|
|Estimated Study Completion Date :||June 2012|
|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
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01239706
|Contact: David Zygun, MDfirstname.lastname@example.org|
|Contact: Stephanie Todd, BSc, MBT, CCRPemail@example.com|
|Foothills Medical Center||Recruiting|
|Calgary, Alberta, Canada, T2N2T9|
|Contact: Stephanie Todd, BSc, MBT, CCRP 403-944-3414 firstname.lastname@example.org|
|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|
|Principal Investigator:||David A Zygun, MD, MSc||University of Calgary|