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

NCT00418275 | Completed Phase 1

• 1 other identifier: GB-001-P02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cerebrovascular Accident

Keywords

Cerebrovascular Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

Interventions

Recombinant Human Plasminogen Activator (HTUPA) GENETIC

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Global Biotech: lead

Study Sites (1)

Veterans General Hospita-lNeurological Institute

No. 201, Sec. 2, Shih-Pai Road, Taipei, 112, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 16424373 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Han-Hwa Hu, M.D.

  Taipei Veterans General Hospita-lNeurological Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 3, 2007
• First Posted: January 4, 2007
• Study Start: April 1, 2001
• Study Completion: June 1, 2004
• Last Updated: January 4, 2007

Record last verified: 2006-12

Locations

TW (1)