NCT00808626

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2008

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 16, 2008

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

May 4, 2015

Status Verified

May 1, 2015

Enrollment Period

8.3 years

First QC Date

December 12, 2008

Last Update Submit

May 1, 2015

Conditions

Venous Thrombosis

Outcome Measures

Primary Outcomes (1)

  • Establish the proof of concept that 99mTc-rBitistatin enables imaging of peripheral venous thrombi

    1-4 hours after administration

Secondary Outcomes (1)

  • Continue to evaluate the safety of 99mTc-rBitistatin administered intravenously

    0-4 hr, 6 hr, 3-4 weeks, 3-4 months after administration

Study Arms (1)

99mTc-rBitistatin

EXPERIMENTAL
Drug: 99mTc-rBitistatin

Interventions

99mTc-rBitistatinDRUG

Intravenous administration of a single dose (10 mCi, 0.1 ug/kg body weight) of 99mTc-rBitistatin, followed by collection of scintigraphic (planar and SPECT) images at 1 hour and 2-4 hours.

Also known as: Bitistatin, HN-Bitistatin, 99mTc-Bitis, Bitis
99mTc-rBitistatin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • peripheral acute venous thrombosis diagnosed by vascular ultrasound
  • is able to give informed consent
  • is likely to complete the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Venous Thrombosis

Interventions

bitistatin

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Alan H Maurer, MD

    Temple University Hospital

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 12, 2008

First Posted

December 16, 2008

Study Start

December 1, 2008

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

May 4, 2015

Record last verified: 2015-05

Locations

US(1)