Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin

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.

Study Overview

• Status: Completed
• Conditions: Thrombosis; Thrombocytopenia
• Intervention / Treatment: Drug: Argatroban

• Study Type: Interventional
• Enrollment: 24
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: Encysive Pharmaceuticals
• Collaborators: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Study Completion: March 1, 2006

Study Registration Dates

• First Submitted: June 13, 2002
• First Submitted That Met QC Criteria: June 13, 2002
• First Posted (Estimate): June 14, 2002

Study Record Updates

• Last Update Posted (Estimate): January 11, 2007
• Last Update Submitted That Met QC Criteria: January 10, 2007
• Last Verified: January 1, 2007

More Information

Terms related to this study

• Keywords: anticoagulation; HIT; heparin-induced thrombocytopenia; heparin-induced thrombocytopenia and thrombosis; HITTS
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Embolism and Thrombosis; Blood Platelet Disorders; Thrombosis; Thrombocytopenia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Argatroban
• Other Study ID Numbers: ARG-401; SKF105043/013