Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin
2 other identifiers
interventional
24
1 country
13
Brief Summary
The purpose of this study is to evaluate the safe and effective dose of Argatroban for prophylaxis and/or treatment of thrombosis in pediatric patients with current or previous diagnosis of heparin-induced thrombocytopenia (HIT) and thrombosis syndrome (HITTS), or who in the opinion of the investigator require alternative anticoagulation due to an underlying condition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Sep 2003
Typical duration for phase_4
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2002
CompletedFirst Posted
Study publicly available on registry
June 14, 2002
CompletedStudy Start
First participant enrolled
September 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedJanuary 11, 2007
January 1, 2007
June 13, 2002
January 10, 2007
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Males and females ages birth to 16 years,inclusive, at enrollment. For neonates, the minimum corrected gestational age should be 37 weeks.
- Documented HIT defined as a fall in platelet count to less than 100,000/uL or a \>=50% decrease in platelets after the initiation of heparin therapy with no apparent explanation other than HIT, or
- Require anticoagulation and have a documented history of a positive HIT test in the absence of current thrombocytopenia (i.e. patients at risk for HIT), or
- In the opinion of the investigator, require alternative anticoagulation due to an underlying condition, such as AT-III deficiency or heparin resistance.
- Signed (written) informed consent or assent by the patient (if age appropriate) and the patient's parent or guardian.
You may not qualify if:
- Any condition which, in the investigator's opinion, would contraindicate the use of Argatroban or would endanger the patient if he/she participated in this trial.
- Unexplained aPTT \> 2 times the upper limit of normal at baseline, in the absence of heparin.
- International Normalized Ratio (INR) \>1.6 at baseline in the absence of warfarin.
- Known clinical site of bleeding or predisposition to bleeding (e.g., GI bleed, hematuria, hemorrhagic CVA,retroperitoneal hematoma, diabetic retinopathy, hemorrhagic pericardial effusion, or hemorrhagic pleural effusion. Patients who have a known clinical site of bleeding may be enrolled if the investigator deems the risk of continued thrombosis to outweigh the potential bleeding risk.
- Any patient who has received any investigational medication within 30 days prior to the first dose of study medication or who is scheduled to receive an investigational drug other than Argatroban during the course of the study.
- Known hypersensitivity to Argatroban or chemically related compounds.
- Females of childbearing potential who are pregnant (positive serum beta-HCG), breast feeding, or sexually active and not taking adequate contraceptive precautions (e.g. IUD or oral contraceptives).
- Any patient receiving a thrombolytic medication (e.g. tPA).
- Any neonate with a corrected gestational age of \< or = 44 weeks and bleeding in the head (Grade I or above) as determined by head ultrasound.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Encysive Pharmaceuticalslead
- GlaxoSmithKlinecollaborator
Study Sites (13)
Mattel Children's Hospital at UCLA
Los Angeles, California, 90095, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Chicago Children's Hospital
Chicago, Illinois, 60637, United States
Children's Hospital of Illinois
Peoria, Illinois, 61614, United States
Kosair Children's Hospital, University of Louisville
Louisville, Kentucky, 40202, United States
Children's Hospital of Boston
Boston, Massachusetts, 02115, United States
Michigan Congenital Heart Center
Ann Arbor, Michigan, 48109, United States
Rainbow Babies at Children's Hospital
Cleveland, Ohio, 44106, United States
Oregon Health & Science University
Portland, Oregon, 97201, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Primary Children's Medical Center
Salt Lake City, Utah, 84113, United States
Children's Hospital and Regional Medical Center
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 13, 2002
First Posted
June 14, 2002
Study Start
September 1, 2003
Study Completion
March 1, 2006
Last Updated
January 11, 2007
Record last verified: 2007-01