Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients
A THREE MONTH PROSPECTIVE OPEN LABEL STUDY OF THERAPY WITH FRAGMIN(REGISTERED) (DALTEPARIN SODIUM INJECTION) IN CHILDREN WITH VENOUS THROMBOEMBOLISM WITH OR WITHOUT MALIGNANCIES
3 other identifiers
interventional
38
5 countries
26
Brief Summary
Three month treatment of acute VTE with Fragmin in pediatric cancer patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2009
Longer than P75 for phase_2
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 4, 2009
CompletedFirst Posted
Study publicly available on registry
August 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedResults Posted
Study results publicly available
April 16, 2019
CompletedApril 16, 2019
March 1, 2019
8.6 years
August 4, 2009
March 19, 2019
March 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Median Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Level
Prespecified therapeutic anti-factor Xa level was 0.5-1.0 international unit per milliliter (IU/mL). Cumulative data of Day 1 to 7 has been reported.
4 hours post-dose at each Day 1 to 7 in dose adjustment phase
Secondary Outcomes (21)
Percentage of Participants Who Achieved Prespecified Therapeutic Anti- Factor Xa Levels
Day 1 to 7 in dose adjustment phase
Number of Participants With New or Progressive Symptomatic Venous Thromboembolism (VTE)
Baseline up to 28 days after the last dose of study drug (up to Day 132)
Time to First Occurrence of Symptomatic Recurrent Venous Thromboembolism (VTE)
Baseline up to 28 days after the last dose of study drug (up to Day 132)
Percentage of Participants With Clinical Response of Progression, Regression, Resolution and No Change in Venous Thromboembolism (VTE)
Baseline up to 28 days after the last dose of study drug (up to Day 132)
Percentage of Participants With Major and Minor Bleeding Event
Baseline up to 28 days after the last dose of study drug (up to Day 132)
- +16 more secondary outcomes
Other Outcomes (3)
Total Body Clearance of Dalteparin
4 hours post-dose at each Day 1 to 7 in dose adjustment phase
Volume of Distribution of Dalteparin
4 hours post-dose at each Day 1 to 7 in dose adjustment phase
Absorption Rate Constant (Ka) of Dalteparin
4 hours post-dose at each Day 1 to 7 in dose adjustment phase
Study Arms (1)
Single Arm
OTHERSingle arm open-label
Interventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (26)
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Nemours Children's Clinic
Jacksonville, Florida, 32207, United States
Wolfson Children's Hospital
Jacksonville, Florida, 32207, United States
Investigational Drug Service Tampa General Hospital
Tampa, Florida, 33606, United States
Tampa General Hospital Center of Research Excellence
Tampa, Florida, 33606, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
University of South Florida
Tampa, Florida, 33606, United States
St. Joseph's Children's Hospital of Tampa
Tampa, Florida, 33607, United States
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
El Paso Children's Hospital
El Paso, Texas, 79905, United States
Texas Tech University Health Sciences Center El Paso
El Paso, Texas, 79905, United States
Texas Children's Cancer and Hematology Centers
Houston, Texas, 77030, United States
Texas Children's Hospital Investigational Pharmacy Services
Houston, Texas, 77030, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Sykehusapoteket Oslo
Oslo, 0372, Norway
Oslo universitetssykehus HF
Oslo, 0424, Norway
FSBEI HE Kazan SMU of Minzdrav Russia
Kazan', Republic Tatarstan, 420012, Russia
SAHI "Children's Republican Clinical Hospital of the Ministry of
Kazan', Republic Tatarstan, 420138, Russia
SBHI of Moscow city Morozovskaya Children City Clinical Hospital of Moscow city
Moscow, 119049, Russia
Lekarna, Univerzitetni klinicni center Ljubljana
Ljubljana, SI-1000, Slovenia
Pediatricna klinika, Univerzitetni Klinicni Center Ljubljana
Ljubljana, SI-1000, Slovenia
Hospital HM Universitario Monteprincipe Servicio de Farmacia
Boadilla del Monte, Madrid, 28660, Spain
Hospital HM Universitario Monteprincipe
Boadilla del Monte, Madrid, 28660, Spain
Related Publications (2)
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.
PMID: 35678616DERIVEDDamle 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.
PMID: 32827160DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2009
First Posted
August 6, 2009
Study Start
August 1, 2009
Primary Completion
March 1, 2018
Study Completion
March 1, 2018
Last Updated
April 16, 2019
Results First Posted
April 16, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.