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

• ClinicalTrials.gov Identifier: NCT00039858
• Recruitment Status: Completed
• First Posted: June 14, 2002
• Last Update Posted: January 11, 2007
• Sponsor: Encysive Pharmaceuticals
• Collaborator: GlaxoSmithKline
• Information provided by: Encysive Pharmaceuticals

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Thrombocytopenia; Thrombosis	Drug: Argatroban	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 24 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin
• Study Start Date: September 2003
• Study Completion Date: March 2006

Arms and Interventions

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: up to 16 Years (Child)
• Sexes Eligible for Study: All
• 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

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

Rush University Medical Center

Chicago, Illinois, United States, 60612

University of Chicago Children's Hospital

Chicago, Illinois, United States, 60637

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

• ClinicalTrials.gov Identifier: NCT00039858 History of Changes
• Other Study ID Numbers: ARG-401; SKF105043/013
• First Posted: June 14, 2002
• Last Update Posted: January 11, 2007
• Last Verified: January 2007

Keywords provided by Encysive Pharmaceuticals:

heparin-induced thrombocytopenia; heparin-induced thrombocytopenia and thrombosis; HIT; HITTS; anticoagulation

Additional relevant MeSH terms:

Thrombosis; Thrombocytopenia; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Blood Platelet Disorders; Hematologic Diseases; Heparin; Calcium heparin; Argatroban; Anticoagulants; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Antithrombins; Serine Proteinase Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Platelet Aggregation Inhibitors