Safety Study of Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Traumatic Brain Injury: Dosing Tier 1
Recruitment status was Recruiting
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:||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|
- 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.
- 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
|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)|
|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
|Contact: David Zygun, MDemail@example.com|
|Contact: Stephanie Todd, BSc, MBT, CCRPfirstname.lastname@example.org|
|Foothills Medical Center||Recruiting|
|Calgary, Alberta, Canada, T2N2T9|
|Contact: Stephanie Todd, BSc, MBT, CCRP 403-944-3414 email@example.com|
|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|