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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Encysive Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00039858
First received: June 13, 2002
Last updated: January 10, 2007
Last verified: January 2007
  Purpose

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 Intervention Phase
Thrombocytopenia
Thrombosis
Drug: Argatroban
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin

Resource links provided by NLM:


Further study details as provided by Encysive Pharmaceuticals:

Estimated Enrollment: 24
Study Start Date: September 2003
Estimated Study Completion Date: March 2006
  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00039858

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

No publications provided

ClinicalTrials.gov Identifier: NCT00039858     History of Changes
Other Study ID Numbers: ARG-401, SKF105043/013
Study First Received: June 13, 2002
Last Updated: January 10, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Encysive Pharmaceuticals:
heparin-induced thrombocytopenia
heparin-induced thrombocytopenia and thrombosis
HIT
HITTS
anticoagulation

Additional relevant MeSH terms:
Thrombocytopenia
Thrombosis
Blood Platelet Disorders
Hematologic Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Argatroban
Anticoagulants
Heparin
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on August 19, 2014