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

Primary Purpose

Cerebrovascular Accident

Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
Recombinant Human Plasminogen Activator (HTUPA)
Sponsored by
Global Biotech
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident focused on measuring Cerebrovascular Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Veterans General Hospita-lNeurological Institute

Outcomes

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.

Full Information

First Posted
January 3, 2007
Last Updated
January 3, 2007
Sponsor
Global Biotech
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1. Study Identification

Unique Protocol Identification Number
NCT00418275
Brief Title
Safety Study of a Recombinant Human Plasminogen Activator to Treat Acute Ischemic Stroke.
Official Title
A Dose Finding, Pharmacokinetic and Safety Study of a Recombinant Human Plasminogen Activator (HTU-PA) in Patients With Acute Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Global Biotech

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
Keywords
Cerebrovascular Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
Recombinant Human Plasminogen Activator (HTUPA)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Major neurological improvement measured by NIHSS at 30 minutes, 60 minutes, 2 hours, 48 hours, 7 days, 30 days, and 90 days after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han-Hwa Hu, M.D.
Organizational Affiliation
Taipei Veterans General Hospita-lNeurological Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Veterans General Hospita-lNeurological Institute
City
No. 201, Sec. 2, Shih-Pai Road
State/Province
Taipei
ZIP/Postal Code
112
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
16424373
Citation
Hu HH, Teng MM, Hsu LC, Wong WJ, Wang LM, Luk YO, Chern CM, Soong BW, Sheng WY. A pilot study of a new thrombolytic agent for acute ischemic stroke in Taiwan within a five-hour window. Stroke. 2006 Mar;37(3):918-9. doi: 10.1161/01.STR.0000202591.18871.f7. Epub 2006 Jan 19.
Results Reference
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Safety Study of a Recombinant Human Plasminogen Activator to Treat Acute Ischemic Stroke.

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