Pilot Dose Finding and Pharmacokinetic Study of Fondaparinux in Children With Thrombosis
|ClinicalTrials.gov Identifier: NCT00412464|
Recruitment Status : Completed
First Posted : December 18, 2006
Results First Posted : December 6, 2011
Last Update Posted : April 15, 2015
|Condition or disease||Intervention/treatment||Phase|
|Thrombosis Heparin-induced Thrombocytopenia||Drug: Fondaparinux||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Dose-finding and Pharmacokinetic Study of Fondaparinux in Children With Deep Vein Thrombosis or Heparin-induced Thrombocytopenia|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||December 2009|
- Number of Abnormal Lab Results Resulting in Adverse Events. [ Time Frame: Study period which was up to 21 days of fondaparinux ]The primary outcome measure was assessment of safety by reporting the number of abnormal lab results resulting in adverse events. Safety laboratory assessments are as follows: Liver and kidney toxicity will be determined by serial measurements of AST, ALT, total bilirubin, BUN and creatinine. Hematologic toxicity will be assessed by serial CBCs.
- Therapeutic Plasma Concentration of Fondaparinux at 21 Days [ Time Frame: 21 days ]Subjects all had detailed pharmacokinetic measurements done which were subsequently analyzed in a population pharmacokinetic model. This model then informed the dosing recommendations that were published as a result of the study.
- Bleeding Events [ Time Frame: Study period which was up to 21 days of fondaparinux ]Bleeding assessment Patients will be monitored for bleeding symptoms by physician and nursing assessment. Major bleeding will be defined as bleeding which is in a critical space (intracranial, retroperitoneal, or visceral) or leads to the need for blood transfusion. Minor bleeding will be all other bleeding and will be classified as clinically significant (i.e. If the physician has to take action to treat the minor bleed) or clinically insignificant (i.e. if the physician does not need to intervene to treat the minor bleed).
- Adverse Events [ Time Frame: Study period which was up to 21 days of fondaparinux ]Adverse events will be defined as any untoward or unexpected event which can be a symptom, physical exam sign or laboratory abnormality. Adverse events will be classified as serious if they lead to prolonged hospitalization, re-hospitalization, transfer to an intensive care unit, or death. Adverse events will be categorized in terms of their likely association with fondaparinux as probably related, possibly related, unrelated, or unknown, and will be recorded according to standard adverse reporting guidelines for clinical trials.
- Thrombocytopenic Events [ Time Frame: Study period which was up to 21 days of fondaparinux ]Patient's platelet counts should be kept above 50 x 10^9/L while on study with platelet transfusions as needed with the exception of patients enrolled under the HIT/ suspicion of HIT inclusion (platelet transfusions are contraindicated in HIT). With regards to study patients who experience progressive decreases in platelet count to below 50 x 10^9/L while receiving fondaparinux (excluding patients being treated for HIT or suspicion of HIT), fondaparinux will be discontinued.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00412464
|United States, California|
|Children's Hospital Los Angeles|
|Los Angeles, California, United States, 90027|
|Children's Hospital of Orange County|
|Orange, California, United States, 92868|
|United States, Ohio|
|Nationwide Children's Hospital|
|Columbus, Ohio, United States, 43205|
|United States, Texas|
|Texas Children's Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Guy Young, MD||Children’s Hospital of Orange County|