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Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients

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ClinicalTrials.gov Identifier: NCT00952380
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Drug: dalteparin Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 20, 2009
Actual Primary Completion Date : March 20, 2018
Actual Study Completion Date : March 20, 2018

Arm Intervention/treatment
Single Arm
Single arm open-label
Drug: dalteparin
dalteparin subcutaneous injection




Primary Outcome Measures :
  1. Efficacy [ Time Frame: 90 Days ]
    Efficacy: Thrombus resolution at the end of study or early termination visit will be measured by repeating the same imaging method used at baseline. [ Time Frame: 90 days ] [ Designated as safety issue: No ]


Secondary Outcome Measures :
  1. Safety [ Time Frame: 90 Days ]
    Safety Outcomes will consist of major bleeding episodes, recurrent DVT/Pulmonary embolism and unexpected serious adverse events (SAEs). [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00952380


Locations
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
United States, District of Columbia
MedStar Georgetown University Hospital
Washington, District of Columbia, United States, 20007
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Wolfson Children's Hospital
Jacksonville, Florida, United States, 32207
Investigational Drug Service Tampa General Hospital
Tampa, Florida, United States, 33606
Tampa General Hospital Center of Research Excellence
Tampa, Florida, United States, 33606
Tampa General Hospital
Tampa, Florida, United States, 33606
University of South Florida
Tampa, Florida, United States, 33606
St. Joseph's Children's Hospital of Tampa
Tampa, Florida, United States, 33607
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, Missouri
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
United States, Texas
El Paso Children's Hospital
El Paso, Texas, United States, 79905
Texas Tech University Health Sciences Center
El Paso, Texas, United States, 79905
Texas Children's Cancer and Hematology Centers
Houston, Texas, United States, 77030
Texas Children's Hospital Investigational Drug Services
Houston, Texas, United States, 77030
Texas Children's Hospital
Houston, Texas, United States, 77030
Norway
Sykehusapoteket Oslo
Oslo, Norway, 0372
Oslo universitetssykehus HF
Oslo, Norway, 0424
Russian Federation
FSBEI HE Kazan SMU of Minzdrav Russia
Kazan, Republic Tatarstan, Russian Federation, 420012
SAHI "Children's Republican Clinical Hospital of the Ministry of
Kazan, Republic Tatarstan, Russian Federation, 420138
SBHI of Moscow city Morozovskaya Children City Clinical Hospital of Moscow city
Moscow, Russian Federation, 119049
Slovenia
Lekarna, Univerzitetni klinicni center Ljubljana
Ljubljana, Slovenia, SI-1000
Pediatricna klinika, Univerzitetni Klinicni Center Ljubljana
Ljubljana, Slovenia, SI-1000
Spain
Hospital HM Universitario Monteprincipe Servicio de Farmacia
Boadilla del Monte, Madrid, Spain, 28660
Hospital HM Universitario Monteprincipe
Boadilla del Monte, Madrid, Spain, 28660
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00952380     History of Changes
Other Study ID Numbers: FRAG-A001-201
A6301094 ( Other Identifier: Alias Study Number )
2016‐000394‐21 ( EudraCT Number )
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
URL: http://

Keywords provided by Pfizer:
VTE

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Dalteparin
Heparin, Low-Molecular-Weight
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action