Clinical trial NCT00952380: Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients
Official title: A THREE MONTH PROSPECTIVE OPEN LABEL STUDY OF THERAPY WITH FRAGMIN(REGISTERED) (DALTEPARIN SODIUM INJECTION) IN CHILDREN WITH VENOUS THROMBOEMBOLISM WITH OR WITHOUT MALIGNANCIES
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Venous Thromboembolism
Keywords: VTE
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-08-06
Enrollment: 38
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Three month treatment of acute VTE with Fragmin in pediatric cancer patients

Detailed description: Primary study objectives include are to determine the pharmacodynamic (PD) profiles for treatment doses of dalteparin in pediatric subjects of different ages with cancer and venous thromboembolism (VTE), using anti-Xa (Xa) levels and a population PD analysis methodology, and to determine the median dose required to achieve therapeutic anti- Xa levels (0.5 to 1.0 International Units \[IU\]/mL) based on subject age and weight.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
measure: Median Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Level
timeFrame: 4 hours post-dose at each Day 1 to 7 in dose adjustment phase
Secondary outcomes:
measure: Percentage of Participants Who Achieved Prespecified Therapeutic Anti- Factor Xa Levels
timeFrame: Day 1 to 7 in dose adjustment phase
measure: Number of Participants With New or Progressive Symptomatic Venous Thromboembolism (VTE)
timeFrame: Baseline up to 28 days after the last dose of study drug (up to Day 132)
measure: Time to First Occurrence of Symptomatic Recurrent Venous Thromboembolism (VTE)
timeFrame: Baseline up to 28 days after the last dose of study drug (up to Day 132)
measure: Percentage of Participants With Clinical Response of Progression, Regression, Resolution and No Change in Venous Thromboembolism (VTE)
timeFrame: Baseline up to 28 days after the last dose of study drug (up to Day 132)
measure: Percentage of Participants With Major and Minor Bleeding Event
timeFrame: Baseline up to 28 days after the last dose of study drug (up to Day 132)
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 28 days after the last dose of study drug (up to Day 132)
measure: Number of Participants With Laboratory Abnormalities
timeFrame: Baseline up to 104 days
measure: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSBP) in Participants
timeFrame: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90
measure: Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants
timeFrame: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90
measure: Absolute Values of Height of Participants
timeFrame: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90
measure: Absolute Values of Weight of Participants
timeFrame: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90
measure: Absolute Values of Respiratory Rate of Participants
timeFrame: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90
measure: Absolute Values of Body Temperature of Participants
timeFrame: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90
measure: Absolute Values of Body Length of Participants
timeFrame: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90
measure: Number of Participants With Physical Examination Abnormalities of Participants
timeFrame: Screening, Visit 2 (Baseline), Visit 3 (Day 1), Visit 4 (Day 2), Visit 5 (Day 30), Visit 6 (Day 60), Visit 7 (Day 90)
measure: Time to First Occurrence of Major Bleeding Event
timeFrame: Baseline up to 28 days after the last dose of study drug (up to Day 132)
measure: Percentage of Participants Who Remained Within Prespecified Therapeutic Anti-Factor Xa Levels at Day 30, 60 and 90 in Follow up Phase
timeFrame: Day 30, Day 60, Day 90 in follow up phase
measure: Percentage of Participants With Anti-Factor Xa Levels Outside the Prespecified Range at Day 30, 60 and 90 in Follow up Phase
timeFrame: Day 30, Day 60, Day 90 in follow-up phase
measure: Maintenance Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Levels
timeFrame: 4 hours post-dose at each Day 1 to 7 in dose adjustment phase
measure: Time to Achieve Prespecified Therapeutic Anti- Factor Xa Levels
timeFrame: Day 1 to 7 in dose adjustment phase
measure: Number of Dose Adjustments Required to Achieve Prespecified Therapeutic Anti-Xa Levels
timeFrame: 4 hours post-dose at each Day 1 to 7 in dose adjustment phase
Other outcomes:
measure: Total Body Clearance of Dalteparin
timeFrame: 4 hours post-dose at each Day 1 to 7 in dose adjustment phase
measure: Volume of Distribution of Dalteparin
timeFrame: 4 hours post-dose at each Day 1 to 7 in dose adjustment phase
measure: Absorption Rate Constant (Ka) of Dalteparin
timeFrame: 4 hours post-dose at each Day 1 to 7 in dose adjustment phase
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Jacksonville
country: United States
facility: Nemours Children's Clinic
state: Florida
city: Jacksonville
country: United States
facility: Wolfson Children's Hospital
state: Florida
city: Tampa
country: United States
facility: Investigational Drug Service Tampa General Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital Center of Research Excellence
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Tampa
country: United States
facility: St. Joseph's Children's Hospital of Tampa
state: Florida
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
city: Kansas City
country: United States
facility: Children's Mercy Hospitals and Clinics
state: Missouri
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
city: El Paso
country: United States
facility: El Paso Children's Hospital
state: Texas
city: El Paso
country: United States
facility: Texas Tech University Health Sciences Center El Paso
state: Texas
city: Houston
country: United States
facility: Texas Children's Cancer and Hematology Centers
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital Investigational Pharmacy Services
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Oslo
country: Norway
facility: Sykehusapoteket Oslo
city: Oslo
country: Norway
facility: Oslo universitetssykehus HF
city: Kazan
country: Russian Federation
facility: FSBEI HE Kazan SMU of Minzdrav Russia
state: Republic Tatarstan
city: Kazan
country: Russian Federation
facility: SAHI "Children's Republican Clinical Hospital of the Ministry of
state: Republic Tatarstan
city: Moscow
country: Russian Federation
facility: SBHI of Moscow city Morozovskaya Children City Clinical Hospital of Moscow city
city: Ljubljana
country: Slovenia
facility: Lekarna, Univerzitetni klinicni center Ljubljana
city: Ljubljana
country: Slovenia
facility: Pediatricna klinika, Univerzitetni Klinicni Center Ljubljana
city: Boadilla del Monte
country: Spain
facility: Hospital HM Universitario Monteprincipe Servicio de Farmacia
state: Madrid
city: Boadilla del Monte
country: Spain
facility: Hospital HM Universitario Monteprincipe
state: Madrid
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Hartman LR, Nurmeev I, Svirin P, Wolter KD, Yan JL, Jani D, Goldenberg NA, Sherman N. A phase 2 pharmacodynamic dose-finding, safety, and efficacy study of dalteparin for pediatric venous thromboembolism treatment in children with and without cancer. Pediatr Blood Cancer. 2022 Aug;69(8):e29764. doi: 10.1002/pbc.29764. Epub 2022 Jun 9.
citation: Damle B, Jen F, Sherman N, Jani D, Sweeney K. Population Pharmacokinetic Analysis of Dalteparin in Pediatric Patients With Venous Thromboembolism. J Clin Pharmacol. 2021 Feb;61(2):172-180. doi: 10.1002/jcph.1716. Epub 2020 Aug 21.