Beta-hCG + Erythropoietin in Acute Stroke

NCT00362414 | Completed Phase 2 Results

• 1 other identifier: HS#2005-4800
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Stroke

Keywords

Stroke

Outcome Measures

Primary Outcomes (3)

• Safety

  Safety through Day 90 was assessed through adverse event reporting, serial examinations, blood testing, and a leg vein Doppler at Day 42. Number of participants who experienced adverse events, had abnormality in serial examinations, blood testing, and a leg vein Doppler at Day 42.

  3 mo

• Morbidity

  attributable to experimental intervention

  3 mo

• Mortality

  attributable to experimental intervention

  3 mo

Secondary Outcomes (11)

• Action Research Arm Test

  3 mo

• Fugl-Meyer Arm Scale

  3 mo

• Fugl-Meyer Leg Scale

  3 mo.

• Boston Naming Test

  3 mo

• Line Cancellation Test

  3 mo

Study Arms (1)

Dual Growth Factor

EXPERIMENTAL

All patients received erythropoietin and beta-hCG. This was the only treatment arm in the study, i.e., all enrollees received active therapy.

Drug: Dual Growth Factor

Interventions

Dual Growth Factor DRUG

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

Dual Growth Factor

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of California, Irvine: lead
• Stem Cell Therapeutics Corp.: collaborator
• Hoag Memorial Hospital Presbyterian: collaborator

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92868-4280, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Steven Cramer
• Organization: University of California Irvine

scramer@uci.edu

(714) 456-6876

Study Officials

• Steven C. Cramer, MD, MMSc

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 9, 2006
• First Posted: August 10, 2006
• Study Start: August 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: August 29, 2016
• Results First Posted: August 29, 2016

Record last verified: 2016-08

Locations

US (1)