Safety Study of a Recombinant Human Plasminogen Activator to Treat Acute Ischemic Stroke.

January 3, 2007 updated by: Global Biotech

A Dose Finding, Pharmacokinetic and Safety Study of a Recombinant Human Plasminogen Activator (HTU-PA) in Patients With Acute Ischemic Stroke

To evaluate the safety profiles of HTU-PA in patients with acute ischemic stroke.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cerebrovascular disease, the third leading cause of death after heart disease and cancer in developed countries, has an overall prevalence of 794 per 100,000. In the United States, it is estimated that more than 400,000 patients are discharged each year from hospitals after a stroke. The loss of these patients from the work force and the extended hospitalization they require during recovery make serious economic impact. In Taiwan, Cerebrovascular disease is the second cause of death.

Study Type

Interventional

Enrollment

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Taipei
      • No. 201, Sec. 2, Shih-Pai Road, Taipei, Taiwan, 112
        • Veterans General Hospita-lNeurological Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with cerebral ischemia at any location producing a serious measurable deficit by NIHSS scale and who received study medication within 5 hours after the onset of the symptom. A serious measurable deficit by NIHSS was defined as the NIHSS  9 and  20 (for brain stem stroke, patients with NIHSS > 20 were included).
  • Subjects were  18 years old, of either sex.
  • Subjects or his/her legal guardians demonstrated their willingness to participate in the study and comply with its procedures by signing a written informed consent.
  • Subjects with Modified Rankin Scale > 1.

Exclusion Criteria:

  • Onset of symptoms on awaking from sleep.
  • Intracranial bleeding detected on a pretreatment head computerized tomographic (CT) scan.
  • Clinical presentation suggested a subarachnoid hemorrhage even if the head CT scan was normal.
  • Head CT showed the evidence of early infarct sign > 1/3 of MCA territory.
  • Subjects had generalized seizure at the onset of the stroke.
  • Subjects with blood glucose < 50 mg/dl or > 400 mg/dl.
  • Subjects had another stroke, head trauma, cerebral hemorrhage or ischemic infarction within 3 months prior to the study entry.
  • Subjects with a significant surgery within 14 days prior to study entry.
  • Subjects with a history of gastrointestinal or urinary tract hemorrhage within 21 days prior to the study entry.
  • Subjects with lumbar puncture or arterial puncture of non-compressible site within 14 days prior to the study entry.
  • Subjects had known bleeding diathesis.
  • Subjects with other serious medical illness that interfered with the study.
  • Subjects had a platelet count < 100,000/mm3; hematocrit < 30%.
  • Subjects with other serious medical illness that interfered with the study.
  • Subjects had aPTT or PT > upper normal limit.
  • Subjects had uncontrolled hypertension (> 180 mmHg systolic or > 110 mmHg diastolic) without additional anti-hypertensive medication at screening visit.
  • Subjects with recent transmural myocardial infarction and evidence of pericarditis within 3 weeks prior to the enrollment.
  • Subjects had intracranial neoplasm, arteriovenous malformation, or aneurysm.
  • Subjects had hemostasis defects including secondary to severe hepatic or renal disease.
  • Subjects with history of drug or alcohol abuse within 1 year prior to the study entry.
  • Subjects had significant hepatic dysfunction (SGOT/SGPT  3 x upper normal limit).
  • Subjects had serum creatinine level  2 x upper normal limit or on renal dialysis.
  • Subjects had administration of any other investigational drug within 30 days prior to study entry.
  • Woman who was pregnant or nursing.
  • Subjects had used other thrombolytics (streptokinase, tissue plasminogen activator, urokinase, anisoylated plasminogen streptokinase activator complex, anticoagulants).
  • Subjects had severe cardiac disease (New York Heart Association Functional Classification III and IV).
  • Subjects had history of cancer except inactive non-melanoma skin cancer, in situ carcinoma of the cervix, or any cancer in patient's disease free for more than 5 years.
  • Subjects had any clinically significant deviation from normal in the physical examination that, in the investigator judgment, interfered with the study evaluation or affect subject safety.
  • Subjects with history of lupus.
  • Vasculitis was the cause of ischemic stroke.
  • Subjects had been enrolled in this study previously.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Major neurological improvement measured by NIHSS at 24 hours after treatment. "Major neurological improvement" is defined as 4-point improvement in the NIHSS measurement.

Secondary Outcome Measures

Outcome Measure
Major neurological improvement measured by NIHSS at 30 minutes, 60 minutes, 2 hours, 48 hours, 7 days, 30 days, and 90 days after treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Global Biotech

Investigators

  • Study Chair: Han-Hwa Hu, M.D., Taipei Veterans General Hospita-lNeurological Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Study Completion

June 1, 2004

Study Registration Dates

First Submitted

January 3, 2007

First Submitted That Met QC Criteria

January 3, 2007

First Posted (Estimate)

January 4, 2007

Study Record Updates

Last Update Posted (Estimate)

January 4, 2007

Last Update Submitted That Met QC Criteria

January 3, 2007

Last Verified

December 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GB-001-P02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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