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.

Condition	Treatment or Intervention	Phase
Thrombocytopenia Thrombosis	Drug: Argatroban	Phase IV

Ages Eligible for Study:  up to  16 Years,  Genders Eligible for Study:  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 invesitgational 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.

Nancy S Sendecki      610-787-3528    Nancy.S.Sendecki@gsk.com

California
      Children's Hospital of Orange County, Orange,  California,  92868,  United States; Recruiting
      Mattel Children's Hospital at UCLA, Los Angeles,  California,  90095,  United States; Recruiting
Illinois
      Children's Hospital of Illinois, Peoria,  Illinois,  61614,  United States; Recruiting
      University of Chicago Children's Hospital, Chicago,  Illinois,  60637,  United States; Recruiting
      Rush University Medical Center, Chicago,  Illinois,  60612,  United States; Recruiting
Kentucky
      Kosair Children's Hospital, University of Louisville, Louisville,  Kentucky,  40202,  United States; Recruiting
Massachusetts
      Children's Hospital of Boston, Boston,  Massachusetts,  02115,  United States; Recruiting
Michigan
      Michigan Congenital Heart Center, Ann Arbor,  Michigan,  48109,  United States; Recruiting
Ohio
      Rainbow Babies at Children's Hospital, Cleveland,  Ohio,  44106,  United States; Recruiting
Oregon
      Oregon Health & Science University, Portland,  Oregon,  97201,  United States; Recruiting
Pennsylvania
      Children's Hospital of Philadelphia, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
Utah
      Primary Children's Medical Center, Salt Lake City,  Utah,  84113,  United States; Recruiting
Washington
      Children's Hospital and Regional Medical Center, Seattle,  Washington,  98105,  United States; Recruiting

Study ID Numbers:  ARG-401; SKF105043/013
Record last reviewed:  February 2005
Last Updated:  February 8, 2005
Record first received:  June 13, 2002
ClinicalTrials.gov Identifier:  NCT00039858
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08