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Cathflo Activase (Alteplase) - Summary

 
 



SUMMARY

Cathflo® Activase® (Alteplase) is a tissue plasminogen activator (t-PA) produced by recombinant DNA technology. It is a sterile, purified glycoprotein of 527 amino acids. It is synthesized using the complementary DNA (cDNA) for natural human tissue-type plasminogen activator (t-PA) obtained from an established human cell line. The manufacturing process involves secretion of the enzyme Alteplase into the culture medium by an established mammalian cell line (Chinese hamster ovary cells) into which the cDNA for Alteplase has been genetically inserted. Fermentation is carried out in a nutrient medium containing the antibiotic gentamicin sulfate, 100 mg/L. The presence of the antibiotic is not detectable in the final product.

Cathflo® Activase® (Alteplase) is indicated for the restoration of function to central venous access devices as assessed by the ability to withdraw blood.


See all Cathflo Activase indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Cathflo Activase (Alteplase)

Increased benefit of alteplase in patients with ischemic stroke and a high body temperature. [2013]
(PAIS) trial... CONCLUSION: Patients with ischemic stroke and a high body temperature may have a

The effects of alteplase 3 to 6 hours after stroke in the EPITHET-DEFUSE combined dataset: post hoc case-control study. [2013]
using coregistration techniques... CONCLUSIONS: The data provide further evidence that alteplase significantly

Statistical aspects of the TNK-S2B trial of tenecteplase versus alteplase in acute ischemic stroke: an efficient, dose-adaptive, seamless phase II/III design. [2011.08]
BACKGROUND: TNK-S2B, an innovative, randomized, seamless phase II/III trial of tenecteplase versus rt-PA for acute ischemic stroke, terminated for slow enrollment before regulatory approval of use of phase II patients in phase III. PURPOSE: (1) To review the trial design and comprehensive type I error rate simulations and (2) to discuss issues raised during regulatory review, to facilitate future approval of similar designs... CONCLUSIONS: (1) The design was innovative and efficient. Per protocol, type I error was well controlled for the co-primary phase III hypothesis tests, and experiment-wise. (2a) Time must be allowed for communications with regulatory reviewers from first design stages. (2b) Adequate type I error control must be demonstrated. (2c) Greater clarity is needed on (i) whether this includes demonstration of type I error control if the protocol is violated and (ii) whether simulations of type I error control are acceptable. (2d) Regulatory agency concerns that protocols for futility stopping may not be followed may be allayed by submitting interim analysis results to them as these analyses occur.

SYNTHESIS expansion: design of a nonprofit, pragmatic, randomized, controlled trial on the best fast-track endovascular treatment vs. standard intravenous alteplase for acute ischemic stroke. [2011.06]
Rationale Reperfusion in ischemic stroke can be pursued by either systemic intravenous thrombolysis or endovascular treatment. However, systemic intravenous thrombolysis with alteplase within 4.5 h of symptom onset in selected patients is the only medication of proven efficacy... Secondary: neurological deficit seven-days after thrombolysis and the safety of the procedure on the basis of events reported within seven-days following thrombolysis - symptomatic cerebral hemorrhage, fatal and nonfatal stroke, death from any cause, neurological deterioration.

Statistical aspects of the TNK-S2B trial of tenecteplase versus alteplase in acute ischemic stroke: an efficient, dose-adaptive, seamless phase II/III design. [2011]
facilitate future approval of similar designs... CONCLUSIONS: (1) The design was innovative and efficient. Per protocol, type I

more studies >>

Clinical Trials Related to Cathflo Activase (Alteplase)

Cathflo Activase Pediatric Study [Completed]
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.

Phase II Clinical Trial on Treatment of Intraventricular Hemorrhage [Recruiting]
The specific objective of this trial is to determine the lowest dose possible with the best pharmacokinetic and safety profile and it's ability to remove a blood clot from the ventricular system.

Safety and Efficacy of Tissue Plasminogen Activator (tPA) in Neonates and Infants [Recruiting]

Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III [Recruiting]
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 and Boehringer Ingelheim, Inc., Ingelheim, Germany) 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).

MIS+rtPA for ICH Evacuation [Recruiting]
The purpose of this trial is to determine the safety of using a combination of minimally invasive surgery and clot lysis with rt-PA to remove intracerebral hemorrhage (ICH). The procedure is to use image-based surgery (MRI or CT) to provide catheter access to ICH for the intervention, which is a one-time clot aspiration followed by instillation of rt-PA over 72 hours. We propose to test if this intervention facilitates more rapid and complete recovery of function and decreased mortality from this condition compared to conventional medical management without subjecting the patient to craniotomy. The specific objective of this trial is to test the safety of this intervention and assess its ability to remove blood clot from brain tissue.

more trials >>

Reports of Suspected Cathflo Activase (Alteplase) Side Effects

Death (5)Pruritus (2)Diabetes Mellitus (2)Skin Reaction (2)Pruritus Generalised (2)Dialysis (2)Hair Growth Abnormal (2)Hyperglycaemia (2)Skin Disorder (2)Nail Growth Abnormal (2)more >>


Page last updated: 2014-11-30

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