Alfimeprase for Thrombolysis in Acute Peripheral Arterial... | NCT00073554

Studies
Alfimeprase for Thrombolysis in Acute Peripheral Arterial Occlusion

NCT00073554

Sponsor

ARCA Biopharma, Inc.

Status

Completed

Last Update Posted

Dec 17, 2009Estimated

Enrollment

100

Phase

Phase 2

Conditions

Arterial Occlusive Diseases
Peripheral Vascular Diseases
Thrombosis

Interventions

Alfimeprase

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NAPA-1

Status Module

Record Verification Date

Nov 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jun 2003

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 24, 2003

First Submission Date that Met QC Criteria

Nov 25, 2003

First Posted Date

Nov 26, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2009

Last Update Posted Date

Dec 17, 2009Estimated

Name	Class
Premier Research	OTHER

Description Module

Brief Summary

This trial is for patients with acute occlusion of one of the arteries supplying blood to the leg. The trial is designed to determine the safety and activity of a novel clot dissolving (thrombolytic) drug (alfimeprase).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100

Name	Type	Description	Arm Group Labels	Other Names
Alfimeprase	Drug

Eligibility Module

Eligibility Criteria

Patients with acute peripheral arterial occlusion of the lower limb (onset of symptoms within 14 days)
Rutherford Class I or IIa (minimal sensory loss, no muscle weakness, audible venous flow)
Age 18 or above
Able to consent
Able to follow up

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Cleveland Clinic Foundation		Cleveland	Ohio		United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11910179	Background	Toombs CF. Alfimeprase: pharmacology of a novel fibrinolytic metalloproteinase for thrombolysis. Haemostasis. 2001 May-Dec;31(3-6):141-7. doi: 10.1159/000048057.

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D016769	Embolism and Thrombosis

ID	Term
D001157	Arterial Occlusive Diseases
D016491	Peripheral Vascular Diseases
D013927	Thrombosis