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Cerebrovascular AccidentPhase 1/2NCT00418275

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

A Phase 1/2 study testing Recombinant Human Plasminogen Activator (HTUPA) in people with Cerebrovascular Accident, run by Global Biotech at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the safety profiles of HTU-PA in patients with acute ischemic stroke. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cerebrovascular Accident
What is being tested?
Recombinant Human Plasminogen Activator (HTUPA)
How many people
30 participants
Where
1 siteTaiwan
Study dates
Apr 2001to Jun 2004
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 31Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Veterans General Hospita-lNeurological Institute

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

Other trials in Taiwan

About this study

Official title: 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.

Read the 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.

Being tested
Recombinant Human Plasminogen Activator (HTUPA)
Keywords
Cerebrovascular Stroke
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recombinant Human Plasminogen Activator (HTUPA)Genetic

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

  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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2007 (estimated)
  2. Study startApr 2001
  3. Study completionJun 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00418275
Sponsor's protocol ID
GB-001-P02
Status last verified
Dec 2006
First submitted
3 Jan 2007
Last updated
4 Jan 2007
Results posted
No

Publications

  • 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.

    PubMed 16424373

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Recombinant Human Plasminogen Activator (HTUPA) in people with Cerebrovascular Accident, run by Global Biotech at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00418275, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2007.

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