Alfimeprase

Overview

Alfimeprase is a recombinant analog of fibrolase. Fibrolase is a zinc-containing metalloproteinase isolated from the venom of the southern copperhead snake (Agkistrodon contortrix contortrix). It is a small protein that contains 203 residues (Randolph et al. 1992). Alfimeprase is being developed by Nuvelo.

Indication

Alfimeprase is being evaluated as a potential treatment for acute ischemic stroke, catheter occlusion (CO) and acute peripheral arterial occlusion (PAO).

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Phase 2 Proof-of-Concept Study of the Safety and Efficacy of Alfimeprase to Rapidly Open Arteries and Restore Brain Function Following a Stroke	2007/07/12	NCT00499902	Phase 2	Terminated	ARCA Biopharma, Inc.
Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Central Catheters	2006/06/30	NCT00346424	Phase 3	Completed	ARCA Biopharma, Inc.
Study of Alfimeprase's Ability to Dissolve Blood Clots in the Leg and Help Prevent the Need for Surgery	2006/06/20	NCT00338585	Phase 3	Terminated	ARCA Biopharma, Inc.
Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Catheters	2006/05/05	NCT00322270	Phase 3	Completed	ARCA Biopharma, Inc.
Study of Alfimeprase to Rapidly Dissolve Blood Clots in the Leg and Help Prevent the Need for Surgery on Leg Arteries	2005/06/27	NCT00115999	Phase 3	Completed	ARCA Biopharma, Inc.
Alfimeprase for Thrombolysis in Acute Peripheral Arterial Occlusion	2003/11/26	NCT00073554	Phase 2	Completed	ARCA Biopharma, Inc.
Trial of a Novel Fibrinolytic (Alfimeprase) to Clear Thrombosed Vascular Access Devices	2003/11/25	NCT00073515	Phase 2	Completed	ARCA Biopharma, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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