Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00362414
Status:
COMPLETED
Last Update Posted:
2016-08-29
First Post:
2006-08-09
Brief Title:
Beta-hCG Erythropoietin in Acute Stroke
Sponsor:
University of California Irvine
Organization:
University of California Irvine
Study Overview
Official Title:
Safety of Beta-hCG Erythropoietin in Acute Stroke
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BETAS
Brief Summary:
The purpose of this study is to assess the safety of Beta-hCG Erythropoietin in patients with acute ischemic stroke
Detailed Description:
Patients with a new stroke will be evaluated at the University of California Irvine Medical Center UCIMC a JCAHO-certified Stroke Center and at Hoag Memorial Hospital Presbyterian Standard stroke pathways will be used to identify such patients and to initiate standard of care therapy Patients potentially eligible for study enrollment will be identified screened then consented and enrolled Those meeting all entry criteria and no exclusion criteria will undergo additional baseline testing including brain MRI A 9-day course of B-E therapy will then begin always within 48 hours after stroke onset This therapy will consist of hCG 3 once-daily IM doses at 10000 IU per dose one day apart on days 1 3 and 5 of study participation followed by a one day washout period day 6 followed by Epo three once-daily iv doses at 30000 IU per dose on days 7 8 and 9 of study participation Patients will be examined at several time points during therapy as well as 6 weeks and 3 months after stroke onset The primary outcome measures are related to safety while secondary outcome measures are related to disability neurological status and MRI measures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None