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

Temple University

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Venous Thrombosis

Treatments: Drug: 99mTc-rBitistatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00808626

11556 (Registry Identifier)

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

99mTc-rBitistatin

Experimental group

Treatment:

Drug: 99mTc-rBitistatin