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

This study has been completed.
Sponsor:
Information provided by:
Global Biotech
ClinicalTrials.gov Identifier:
NCT00418275
First received: January 3, 2007
Last updated: NA
Last verified: December 2006
History: No changes posted
  Purpose

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


Condition Intervention Phase
Cerebrovascular Accident
Genetic: Recombinant Human Plasminogen Activator (HTUPA)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Dose Finding, Pharmacokinetic and Safety Study of a Recombinant Human Plasminogen Activator (HTU-PA) in Patients With Acute Ischemic Stroke

Resource links provided by NLM:


Further study details as provided by Global Biotech:

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

Estimated Enrollment: 30
Study Start Date: April 2001
Estimated Study Completion Date: June 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418275

Locations
Taiwan
Veterans General Hospita-lNeurological Institute
No. 201, Sec. 2, Shih-Pai Road, Taipei, Taiwan, 112
Sponsors and Collaborators
Global Biotech
Investigators
Study Chair: Han-Hwa Hu, M.D. Taipei Veterans General Hospita-lNeurological Institute
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00418275     History of Changes
Other Study ID Numbers: GB-001-P02
Study First Received: January 3, 2007
Last Updated: January 3, 2007
Health Authority: Taiwan: Department of Health

Keywords provided by Global Biotech:
Cerebrovascular Stroke

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Plasminogen
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on August 21, 2014