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

Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00039858
• Other study ID #: ARG-401
• Secondary ID: SKF105043/013
• Status: Completed
• Phase: Phase 4
• First received: June 13, 2002
• Last updated: January 10, 2007
• Start date: September 2003
• Est. completion date: March 2006

Study information

• Verified date: January 2007
• Source: Encysive Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 16 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thrombocytopenia
• Thrombocytosis
• Thrombosis

Intervention

Drug:
• Argatroban

Locations

Country	Name	City	State
United States	Michigan Congenital Heart Center	Ann Arbor	Michigan
United States	Children's Hospital of Boston	Boston	Massachusetts
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Chicago Children's Hospital	Chicago	Illinois
United States	Rainbow Babies at Children's Hospital	Cleveland	Ohio
United States	Mattel Children's Hospital at UCLA	Los Angeles	California
United States	Kosair Children's Hospital, University of Louisville	Louisville	Kentucky
United States	Children's Hospital of Orange County	Orange	California
United States	Children's Hospital of Illinois	Peoria	Illinois
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	Primary Children's Medical Center	Salt Lake City	Utah
United States	Children's Hospital and Regional Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Encysive Pharmaceuticals	GlaxoSmithKline

Country where clinical trial is conducted

United States,