Multi Centre, Phase Ib Safety Study of anti-fibrin humanised monoclonal antibody (DI-DD3B6/22-80B3) Fab' Protein Fragment (ThromboView) conjugated with Technetium-99m in the Detection of Pulmonary Emboli

Phase 1

Recruiting

• Conditions: Diagnosis of Pumonary Emboli (PE); Cardiovascular - Clotting disorders; Respiratory - Clotting disorders

• Registration Number: ACTRN12605000010695
• Lead Sponsor: AGEN Biomedical Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-07-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Ability to sign informed consent; Onset of most recent episode of symptoms of PE occurring within 7 days of enrolment; Positive diagnosis of PE by CTPA performed in last 72 hours; Women of child-bearing potential to have negative serum pregnancy test at time of enrolment. Both male and female participants agree to use effective contraception for first thirty (30) days of study participation.

Exclusion Criteria

Previously documented PE; Unable to undergo required imaging protocol; Prior exposure to murine/ chimeric/ humanized antibodies; Therapeutic anticoagulation for more than 72 hours prior to ThromboView administration; Thrombolytic therapy during current presentation; Renal dysfunction (serum creatinine >1.5 x ULN), renal transplant; Hepatic Dysfunction (serum transaminases > 3 x ULN); Primary or metastatic malignancies lungs/ pleura; Diffuse active inflammatory/ infectious pulmonary conditions involving > 2 lung segments; Life expectancy < 90 days; Geographic inaccessibility precluding follow up visits; Prior nuclear medicine imaging studies with radiolabelled isotopes (within relative time decay windows); Current pregnancy or lactation or conception intended within 3 months of enrolment and likely inability to gain IV Access.

Study & Design

• Study Type: Interventional
• Study Design: Not specified