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Alfimeprase

Phase 3

Arterial Occlusive Diseases | Small molecule | Cardiovascular |Oruka Therapeutics, Inc.|Last Updated: Feb 3, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLEDDMC
Total Trials2
Total Enrollment400

FDA Designations

No designations recorded

Clinical trial landscape

Alfimeprase · 5 trials · 6 indications

Phase 3 3Phase 2 2
NCT00322270Safety and Efficacy Study of Alfimeprase in Subjects With Occluded CathetersThrombosis
COMPLETED- Analytics
NCT00346424Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Central CathetersThrombosis
COMPLETED300 Analytics
NCT00115999Study of Alfimeprase to Rapidly Dissolve Blood Clots in the Leg and Help Prevent the Need for Surgery on Leg ArteriesArterial Occlusive Diseases
COMPLETED300 Analytics
PHASE3COMPLETED
Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Catheters
ThrombosisUnlock trial analytics
PHASE3COMPLETED
Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Central Catheters
ThrombosisUnlock trial analytics
PHASE3COMPLETED
Study of Alfimeprase to Rapidly Dissolve Blood Clots in the Leg and Help Prevent the Need for Surgery on Leg Arteries
Arterial Occlusive DiseasesUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and efficacy
up to120 minutes post study drug dosing
Catheter function restoration at fifteen minutes after initial instillation of study drug.
15 minutes
30 day open vascular surgery free rate

Secondary Endpoints

Adverse events, serious adverse events and bleeding events
24 hours post dosing
Adverse events up to day 30 visit(day 28-45) after instillation of study drug
approximately 28-45 days post dosing
Catheter function restoration at 30 minutes after initial instillation of study drug.
30 minutes
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
AlfimepraseDRUGsingle-dose of alfimeprase, 10 mg.administered intracatheter to an occluded CVAD
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Must give written informed consent * Ages 18 or older * Unable to withdraw at least 3 mL of blood from a central venous access device * Hemodynamically stable * Available for follow-up assessments Exclusion Criteria: * Inability to infuse at least 2 mL of saline through the ...

Countries:United States
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Frequently asked questions about Alfimeprase

What is Alfimeprase used for?

Alfimeprase is an investigational small molecule being developed for cardiovascular conditions, specifically for arterial occlusive diseases, thrombosis, and occlusion of indwelling catheters. It is designed to clear thrombosed vascular access devices and treat acute peripheral arterial occlusion. The drug is currently in clinical development and has not been approved by the FDA.

Who makes Alfimeprase?

Alfimeprase is being developed by Oruka Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol ORKA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with catheter occlusion and peripheral arterial occlusion.

What phase is Alfimeprase in?

Alfimeprase is in Phase 3 clinical development. The drug has completed Phase 2 and Phase 3 trials for conditions such as occluded catheters and acute peripheral arterial occlusion. It remains an investigational agent and has not received FDA approval for any indication.

What clinical trials is Alfimeprase in?

Alfimeprase has been studied in several completed clinical trials, including NCT00073515 for thrombosed vascular access devices, NCT00073554 for acute peripheral arterial occlusion, NCT00322270 for occluded catheters, and NCT00346424 for occluded central catheters. These trials were conducted in the United States with adult participants.

How does Alfimeprase work?

Alfimeprase is a small molecule that acts as a fibrinolytic agent, meaning it works to break down blood clots. It is being investigated for its ability to clear thrombosed catheters and restore blood flow in arterial occlusive diseases. The drug targets the fibrin component of clots to dissolve them.

Is Alfimeprase the same as any other drug?

Alfimeprase is a distinct investigational drug developed by Oruka Therapeutics. It is not known to be the same as any other marketed medication. Its unique mechanism as a fibrinolytic agent differentiates it from other thrombolytic therapies, though it is still in clinical development.