Research Into the Effect of a Clot-dissolving Agent and Its Inhibitor
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|ClinicalTrials.gov Identifier: NCT01694381|
Recruitment Status : Suspended
First Posted : September 27, 2012
Last Update Posted : January 13, 2015
Single-chain urokinase-type plasminogen activator (pro-urokinase) is a highly effective thrombolytic drug. At pharmacologic concentrations however, pro-urokinase is converted to urokinase - a non specific thrombolytic, limiting its therapeutic use. Mutant pro-urokinase (M5) is more stable and its conversion to urokinase is inhibited by C1-inhibitor.
The primary objectives of the study are:
- To assess the overall safety and tolerability related to systemic plasminogen activation of single doses of M5 over a wide dose range (study part I).
- To assess the effect of single doses of C1-inhibitor on the overall safety and tolerability of single doses of M5 and its effect on M5-induced coagulation changes (study part II).
|Condition or disease|
|Acute Ischemic Stroke|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Phase 1 Trial of Mutant proUK, M5, and Its Inhibitor, C1-inhibitor|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
|mutant pro-urokinase (M5) alone|
|Mutant pro-urokinase (M5) and its inhibitor, C1 inhibitor|
- Changes to vital signs, routine safety laboratory results, or ECG-findings [ Time Frame: -42d, -14h, -15', 15', 30', 45',60', 90', 10h, 24h, 48h, 7d ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01694381
|Center for Human Drug Research|
|Leiden, Netherlands, 2333|
|Principal Investigator:||Koos Burggraaf, MD, PhD||Center for Human Drug Research|