Beta-hCG + Erythropoietin in Acute Stroke

Completed · Phase 2

Conditions studied: Acute Stroke

In brief

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

Key facts

Study ID

NCT00362414

Run by

University of California, Irvine

People needed

15

Starts

2006-08-01

Expected to finish

2008-03-01

Last updated by the study team

2016-08-29

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 21-85
• NIHSS score 6-24 at time of enrollment, ensuring that stroke is neither mild nor devastating
• Stroke is ischemic in origin, supratentorial, and radiologically confirmed
• 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.
• Reasonable expectation of availability to receive the full 9 day B-E therapy course
• Reasonable expectation that patient will receive standard post-stroke physical, occupational, speech, and cognitive therapy as indicated

You may not qualify if…

• Pre-existing and active major psychiatric or other neurological disease
• History of significant alcohol or drug abuse in the prior 3 years
• 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
• 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
• 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.
• Contraindication to study participation on the basis of any of the following:
• Allergy or other contraindication to initiating either beta-hCG or Erythropoietin
• Known hypersensitivity to mammalian cell-derived products or hypersensitivity to albumin
• 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
• Dysuria of unexplained origin
• Uncontrolled hypertension, defined in the context of acute stroke as blood pressure persistently above 220 mm Hg systolic or 120 diastolic despite antihypertensive therapy
• Current use of either beta-hCG or Erythropoietin
• Other condition known to elevate beta-hCG, active in the prior 24 months, e.g., choriocarcinoma or germ cell tumor
• Terminal medical diagnosis consistent with survival < 1 year
• 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.

Where it is running

• University of California, Irvine Medical Center — Orange, California, United States

Full record on ClinicalTrials.gov

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