Intra-arterial Microplasmin Administration in Patients With Acute Peripheral Arterial Occlusion

NCT00123292 | Terminated Phase 2 DMC

• 1 other identifier: TG-M-002
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the trial is to evaluate the safety and efficacy of microplasmin administration in patients with acute peripheral arterial occlusion.

Conditions

Arterial Occlusive Diseases

Keywords

arterial occlusion; thromboembolism; Acute Peripheral Arterial Occlusion

Outcome Measures

Primary Outcomes (1)

• Complete clot-lysis (defined as >95% estimated clot volume reduction compared to baseline angiogram)

  at 4 hours or less (if study drug administration is terminated prior to 4 hours).

Secondary Outcomes (1)

• Proportion of subjects with clot-lysis (complete or partial, defined as any clot volume reduction on angiography)

  At 4 hours or less (if study drug administration is terminated prior to 4 hours).

Study Arms (5)

1

EXPERIMENTAL

Drug: Microplasmin

2

EXPERIMENTAL

Drug: Microplasmin

3

EXPERIMENTAL

Drug: Microplasmin

4a

EXPERIMENTAL

Drug: Microplasmin

4b

EXPERIMENTAL

Drug: Microplasmin

Interventions

Microplasmin DRUG

An infusion of 0.45, 0.60 and 0.90 mg/kg/hr will be administered for up to 4 hours. Study drug will be administered intra-arterially (into the thrombotic occlusion).

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting within 14 days of onset of acute thrombotic or embolic arterial occlusion of a lower extremity (native vessel or bypass graft).
• Complete occlusion of infrarenal vessel or bypass graft, as determined by angiography.
• Lower extremity ischemia graded as SVS/ISCS (Society of Vascular Surgery/ International Society for Cardiovascular Surgery) class I or II (a or b).
• Negative urine pregnancy test (pregnancy test only required for females of child-bearing potential not using an accepted method of contraception).

You may not qualify if:

• Profound ischemia with permanent motor paresis or sensory loss (or ischemic process deemed irreversible, i.e. class III).
• Occlusion not penetrable by the infusion guide wire.
• Known or suspected allergy to contrast agents or heparin sodium.
• Active bleeding or known hemorrhagic diathesis.
• Stroke in the previous 6 months or transient ischemic attack in the previous 2 months.

Sponsors & Collaborators

• ThromboGenics: lead

Study Sites (1)

University Hospital Gasthuisberg

Leuven, B-3000, Belgium

Location

MeSH Terms

Conditions

Arterial Occlusive Diseases; Thromboembolism

Interventions

microplasmin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis

Study Officials

• Peter Verhamme, MD, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2005
• First Posted: July 22, 2005
• Study Start: March 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: November 1, 2009
• Last Updated: April 7, 2014

Record last verified: 2014-04

Locations

BE (1)