Study Of Angiomax In Infants Under Six Months With Thrombosis

NCT00043277 | Completed Phase 2

• 1 other identifier: TMC-BIV-02-04
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The goals of this study are:

1. 1.To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis;
2. 2.To determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time (ACT) or activated partial thromboplastin time (aPTT) in Infants Under Six Months with arterial or venous thrombosis;
3. 3.To determine the outcome of patients on bivalirudin with respect to thrombus resolution and bleeding complications compared to patients on unfractionated heparin (UH) or low molecular weight heparin (LMWH).

Conditions

Thrombosis

Keywords

neonates; thrombosis; bivalirudin; direct thrombin inhibitor

Outcome Measures

Primary Outcomes (1)

• Observation of improvement for thrombosis or by clinical exam such as: Decrease in size of thrombus, restoration of flow through an occluded vessel, decrease in diameter of extremity or head.

Secondary Outcomes (1)

• In addition, efficacy will also be judged by demonstrating a decrease in the molecular markers of thrombin generation.

Interventions

Angiomax (bivalirudin) DRUG

Eligibility Criteria

• Age: 0 Years - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Parent/legal-guardian has provided written informed consent before initiation of any study related procedures.
• Objectively confirmed thrombotic event by either doppler ultrasound, echocardiogram, CT scan, MRI, MR angiogram, MR venogram, venogram or arteriogram.
• Age less than 6 months .
• Gestational age greater than 35 weeks
• Expected life expectancy at least 14 days.
• No contraindication to anticoagulation i.e. bleeding complications.

You may not qualify if:

• Active or recent (less than 7 days) bleeding.
• Known allergy to Angiomax or hirudin, or known sensitivity to any component of the product.
• Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment.
• Refusal to undergo blood transfusion should it become necessary.
• Any other disease or condition, which, in the judgment of the Investigator would place a patient at undue risk by being enrolled in the trial.
• Baseline prolonged PT (\>18 secs) or aPTT (\>55 secs)
• Platelet count \< 50,000 cells/mm3
• Birth Trauma
• Planned or indicated surgery within 30 days
• Major or minor bleeding event

Sponsors & Collaborators

• The Medicines Company: lead

Study Sites (1)

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Thrombosis

Interventions

bivalirudin

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Guy Young, MD

  Children's Hospital Orange County

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 7, 2002
• First Posted: August 8, 2002
• Study Start: August 1, 2002
• Study Completion: December 1, 2004
• Last Updated: February 1, 2006

Record last verified: 2006-01

Locations

US (1)