Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin
Information source: Encysive Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Thrombocytopenia; Thrombosis
Intervention: Argatroban (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Encysive Pharmaceuticals
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.
Clinical Details
Official title: Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Eligibility
Minimum age: N/A.
Maximum age: 16 Years.
Gender(s): Both.
Criteria:
Criteria for Inclusion:
- 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.
Criteria for Exclusion:
- 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.
Locations and Contacts
Children's Hospital of Orange County, Orange, California 92868, United States
Mattel Children's Hospital at UCLA, Los Angeles, California 90095, United States
Children's Hospital of Illinois, Peoria, Illinois 61614, United States
University of Chicago Children's Hospital, Chicago, Illinois 60637, United States
Rush University Medical Center, Chicago, Illinois 60612, 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
Additional Information
Starting date: September 2003
Ending date: March 2006
Last updated: January 10, 2007
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