Beta-hCG + Erythropoietin in Acute Stroke

Acute Stroke Clinical Trial

— BETAS  

Official title:

Safety of Beta-hCG + Erythropoietin in Acute Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00362414
• Other study ID #: HS#2005-4800
• Status: Completed
• Phase: Phase 2
• First received: August 9, 2006
• Last updated: April 24, 2008
• Start date: August 2006
• Est. completion date: March 2008

Study information

• Verified date: April 2008
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety of Beta-hCG + Erythropoietin in patients with acute ischemic stroke.

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 10,000 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 i.v. doses at 30,000 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Age 21-85

2. NIHSS score 6-24 at time of enrollment, ensuring that stroke is neither mild nor devastating

3. Stroke is ischemic in origin, supratentorial, and radiologically confirmed

4. Patient is 24-48 hours from time of stroke onset at time that first dose of B-E therapy is administered. Time of onset is when symptoms began, and stroke occurred during sleep, time of onset is when patient was last seen to be normal.

5. Reasonable expectation of availability to receive the full 9 day B-E therapy course

6. Reasonable expectation that patient will receive standard post-stroke physical, occupational, speech, and cognitive therapy as indicated

Exclusion Criteria:

1. Pre-existing and active major psychiatric or other neurological disease

2. History of significant alcohol or drug abuse in the prior 3 years

3. Serum hemoglobin > 16 g/dL in a male patient or > 14 g/dL in a female patient; or a platelet count > 400,000/mm3 in either a male or female patient

4. Advanced liver, kidney, cardiac, or pulmonary disease; the former will be operationally defined as a serum bilirubin > 4 mg/dL, alkaline phosphatase > 250 U/L, SGOT > 150 U/L, SGPT >150 U/L, or creatinine > 3.5 mg/dL

5. Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years, using a test that reliably detects beta-hCG levels > 25 with normal levels being < 8 IU/L.

6. Contraindication to study participation on the basis of any of the following:

1. Allergy or other contraindication to initiating either beta-hCG or Erythropoietin

2. Known hypersensitivity to mammalian cell-derived products or hypersensitivity to albumin

3. A known diagnosis of prostatic cancer; note that prostate specific antigen will be collected for retrospective assessment of safety, but will not be used to ascertain study eligibility

4. Dysuria of unexplained origin

5. Uncontrolled hypertension, defined in the context of acute stroke as blood pressure persistently above 220 mm Hg systolic or 120 diastolic despite antihypertensive therapy

7. Current use of either beta-hCG or Erythropoietin

8. Other condition known to elevate beta-hCG, active in the prior 24 months, e.g., choriocarcinoma or germ cell tumor

9. Terminal medical diagnosis consistent with survival < 1 year

10. Known hypercoagulable state, which for the purposes of this study will deficiency of proteins C, S, or antithrombin III; activated protein C resistance; prothrombin gene mutation; or an anti-phospholipid antibody syndrome as based on clinical and laboratory measures.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Intervention

Drug:
• Beta-hCG + Erythropoietin
10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation 30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation

Locations

Country	Name	City	State
United States	University of California, Irvine Medical Center	Orange	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Irvine	Hoag Memorial Hospital Presbyterian, Stem Cell Therapeutics Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety		3 mo	Yes
Primary	morbidity		3 mo	Yes
Primary	mortality		3 mo	Yes
Secondary	Action Research Arm Test		3 mo	Yes
Secondary	Fugl-Meyer arm and leg motor scales		3 mo	Yes
Secondary	Boston Naming Test		3 mo	Yes
Secondary	Line Cancellation Test		3 mo	Yes
Secondary	NIH Stroke Scale		3 mo	Yes
Secondary	Geriatric Depression Scale		3 mo	Yes
Secondary	Barthel Index		3 mo	Yes
Secondary	Infarct volume using anatomical MRI		3 mo	Yes
Secondary	Trail Making A & B tests		3 mo	Yes