Phase II Investigation of 99mTc-rBitistatin for Imaging Venous Thrombosis

• Status: Withdrawn
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

Summary

99mTc-rBitistatin is a radiolabeled polypeptide which is designed to stick to blood clots so that the blood clots can be detected by imaging. The purpose of this trial is to evaluate in patients the safety of 99mTc-rBitistatin and its ability to locate blood clots in the arms and legs.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Temple University

Criteria

Inclusion Criteria:

• peripheral acute venous thrombosis diagnosed by vascular ultrasound

• is able to give informed consent

• is likely to complete the study

Exclusion Criteria:

• is pregnant

• is lactating

• has a history of prior severe allergic reactions (anaphylactic response)

• prior use of GP IIb/IIIa antagonist (e.g., abciximab, eptifibatide)

• has a platelet count <100,000 or history of thrombocytopenia

• has a history of stroke

• has a history of recent bleeding documented by decreasing hemoglobin (>1 gm) in last 7 days