Safety and Efficacy of Tissue Plasminogen Activator (tPA) in Neonates and Infants
Terminated
Genentech, Inc.
Phase 1
2005-06-01
The purpose of this study is to determine if alteplase is effective in dissolving a clot in a
catheter in a large vein (central venous line or PICC line) or artery in infants less than 6
months of age.
Safety and Efficacy of Tissue Plasminogen Activator (tPA) in Neonates and Infants
Terminated
University of Louisville
Phase 1
2005-06-01
The purpose of this study is to determine if alteplase is effective in dissolving a clot in a
catheter in a large vein (central venous line or PICC line) or artery in infants less than 6
months of age.
This was a Phase IV, open-label, single-arm, multicenter trial that was to be conducted at
~60 sites in the United States. Approximately 300 pediatric subjects with dysfunctional CVADs
(including catheters with valves, multiple lumens, umbilical catheters, and implanted ports)
were to be treated with up to two serially instilled doses of Cathflo Activase.
Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III
Completed
Emissary International LLC
Phase 3
2009-07-01
The overall objective of this Phase III clinical trial is to obtain information from a
population of 500 ICH subjects with intraventricular hemorrhage (IVH), representative of
current clinical practice and national demographics of ICH regarding the benefit (or lack
thereof) of IVH clot removal on subject function as measured by modified Rankin Scale (mRS).
This application requests funding for five years to initiate a Phase III randomized clinical
trial (RCT) testing the benefit of clot removal for intraventricular hemorrhage. The
investigators propose to compare extraventricular drainage (EVD) use plus recombinant tissue
plasminogen activator (rt-PA; Alteplase; Genentech, Inc., San Francisco, CA) with EVD+
placebo in the management and treatment of subjects with small intracerebral hemorrhage (ICH)
and large intraventricular hemorrhage (IVH defined as ICH < 30 cc and obstruction of the 3rd
or 4th ventricles by intraventricular blood clot).
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