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Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients

Primary Purpose

Venous Thromboembolism

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
dalteparin
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Thromboembolism focused on measuring VTE

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-

Exclusion Criteria:

-

Sites / Locations

  • Children's Hospital Colorado
  • MedStar Georgetown University Hospital
  • Nemours Children's Clinic
  • Wolfson Children's Hospital
  • Investigational Drug Service Tampa General Hospital
  • Tampa General Hospital Center of Research Excellence
  • Tampa General Hospital
  • University of South Florida
  • St. Joseph's Children's Hospital of Tampa
  • Children's Hospital of Michigan
  • Children's Mercy Hospitals and Clinics
  • St. Jude Children's Research Hospital
  • El Paso Children's Hospital
  • Texas Tech University Health Sciences Center El Paso
  • Texas Children's Cancer and Hematology Centers
  • Texas Children's Hospital Investigational Pharmacy Services
  • Texas Children's Hospital
  • Sykehusapoteket Oslo
  • Oslo universitetssykehus HF
  • FSBEI HE Kazan SMU of Minzdrav Russia
  • SAHI "Children's Republican Clinical Hospital of the Ministry of
  • SBHI of Moscow city Morozovskaya Children City Clinical Hospital of Moscow city
  • Lekarna, Univerzitetni klinicni center Ljubljana
  • Pediatricna klinika, Univerzitetni Klinicni Center Ljubljana
  • Hospital HM Universitario Monteprincipe Servicio de Farmacia
  • Hospital HM Universitario Monteprincipe

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Arm

Arm Description

Single arm open-label

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Participants Who Achieved Prespecified Therapeutic Anti- Factor Xa Levels
Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. Percentage of participants who achieved the prespecified level during the dose adjustment phase were reported in this outcome measure.
Number of Participants With New or Progressive Symptomatic Venous Thromboembolism (VTE)
Symptomatic VTE defined as new or progressive signs and symptoms as judged by the investigator including but not limited to: objective swelling, pain or tenderness, pitting edema, erythema or cyanosis. Progression of VTE: Progression of clot burden in terms of severity of occlusion, or involvement of new venous segments at any time after the initial diagnosis.
Time to First Occurrence of Symptomatic Recurrent Venous Thromboembolism (VTE)
It was defined as the time interval (in days) between date of first study treatment and date of documentation of first VTE. VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes PE. When a blood clot breaks, loose and travels in the blood, this is called VTE. VTE was confirmed by at least one radiographic test and was defined as any new or progressive VTE whose signs and symptoms (identified by the investigator) included: objective swelling or tenderness, pitting edema, erythema or cyanosis.
Percentage of Participants With Clinical Response of Progression, Regression, Resolution and No Change in Venous Thromboembolism (VTE)
VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. PE is a blood clot in the lungs. Clinical response of progression was defined as progression of clot burden in terms of severity of occlusion, or involvement of new venous segments at any time after the initial diagnosis. Clinical response of regression: Regressed clot burden utilizing the same imaging modality as the screening visit. Clinical response of resolution: Thrombus resolution of the qualifying event measured by repeat imaging at the end of study (EOS) visit.
Percentage of Participants With Major and Minor Bleeding Event
A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: fatal bleeding, bleeding accompanied by a decrease in hemoglobin of at least 2 grams per deciliter 24 hours, Overt bleeding deemed by the attending physician to necessitate permanent discontinuation of trial medication, Overt bleeding deemed by the attending physician to be unrelated to the participant's underlying condition and accompanied by blood product administration or bleeding occurred at a critical site (intraocular, intracranial, retroperitoneal). A bleeding event was considered as minor if it was clinically overt but not meeting the criteria for major or clinically relevant no major bleeding (bleeding resulting in any medical or surgical interventions but which did not meet the criteria for major bleeding).
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 28 days after the last dose of study drug (up to Day 132) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.
Number of Participants With Laboratory Abnormalities
Criteria:hematology:hemoglobin, hematocrit, erythrocytes less than(<)0.8*lower limit of normal(LLN), platelets <0.5*LLN >1.75*upper limit of normal (ULN),leukocytes <0.6* LLN >1.5* ULN, lymphocytes, lymphocytes/Leukocytes, neutrophils, neutrophils/leukocytes <0.8* LLN >1.2* ULN, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes monocytes monocytes/leukocytes >1.2*ULN, activated partial thromboplastin time, prothrombin time, prothrombin international normalized ratio >1.1* ULN. Clinical chemistry: bilirubin >1.5*ULN, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, alkaline phosphatase >3.0*ULN, protein, albumin <0.8* LLN >1.2* ULN, blood urea nitrogen, creatinine >1.3* ULN, sodium <0.95*LLN >1.05*ULN, potassium, chloride, calcium, magnesium <0.9* LLN >1.1* ULN, phosphate <0.8* LLN >1.2* ULN, glucose <0.6*LLN >1.5*ULN, estimated(est) creatinine clearance, est GFR modified and bedside schwartz, >1.0* ULN. Urinalysis: creatinine >1.0*ULN.
Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSBP) in Participants
Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants
Heart rate and pulse rate of participants were measured in terms of beats per minute.
Absolute Values of Height of Participants
Absolute Values of Weight of Participants
Absolute Values of Respiratory Rate of Participants
Respiratory rate was defined as the number of breaths per minute.
Absolute Values of Body Temperature of Participants
Absolute Values of Body Length of Participants
Number of Participants With Physical Examination Abnormalities of Participants
Physical examinations included head, eyes, ears, nose, throat, neck, heart, chest, lungs, abdomen, extremities, skin, neurological status and general appearance. Abnormality in physical examination was based on investigator's discretion. Only those categories in which at least 1 participant had abnormality were reported.
Time to First Occurrence of Major Bleeding Event
Time to first occurrence of major bleeding event was defined as the time interval (in days) between date of first study treatment and date of documentation of first major bleeding event. A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: fatal bleeding, bleeding accompanied by a decrease in hemoglobin of at least 2 grams per deciliter, overt bleeding deemed by the attending physician to necessitate permanent discontinuation of trial medication, overt bleeding deemed by the attending physician to be unrelated to the participant's underlying condition and accompanied by blood product administration, bleeding occurred at a critical site (intraocular, intracranial, retroperitoneal or intraspinal).
Percentage of Participants Who Remained Within Prespecified Therapeutic Anti-Factor Xa Levels at Day 30, 60 and 90 in Follow up Phase
Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. The percentage of participants who had anti factor-Xa levels within the prespecified therapeutic range at Day 30, 60 and 90 during the follow up phase were reported in this outcome measure.
Percentage of Participants With Anti-Factor Xa Levels Outside the Prespecified Range at Day 30, 60 and 90 in Follow up Phase
Prespecified therapeutic anti-factor Xa range was 0.5-1.0 IU/mL. The percentage of participants who had anti-factor Xa levels outside the prespecified therapeutic range at Day 30, 60 and 90 during the follow up phase were reported in this outcome measure.
Maintenance Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Levels
Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. Cumulative data for day 1 to 7 has been reported.
Time to Achieve Prespecified Therapeutic Anti- Factor Xa Levels
Time to achieve the target range (prespecified therapeutic anti- factor Xa levels) was defined as the number of days from the first dose of study drug to the final dose that achieves the target anti-factor Xa level. Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. Cumulative data of Day 1 to 7 is reported.
Number of Dose Adjustments Required to Achieve Prespecified Therapeutic Anti-Xa Levels
During dose adjustment phase, doses were adjusted according to prespecified therapeutic anti-Xa levels in order to achieve target prespecified therapeutic anti-factor Xa levels (0.5 to 1.0 IU/mL). Number of dose adjustments which were done within the specified time window of up to 4 hours post dose on all days (1 to 7) to achieve the prespecified therapeutic anti-Xa levels are reported.

Full Information

First Posted
August 4, 2009
Last Updated
March 19, 2019
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00952380
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 2009 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
Keywords
VTE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Other
Arm Description
Single arm open-label
Intervention Type
Drug
Intervention Name(s)
dalteparin
Intervention Description
dalteparin subcutaneous injection
Primary Outcome Measure Information:
Title
Median Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Level
Description
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.
Time Frame
4 hours post-dose at each Day 1 to 7 in dose adjustment phase
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieved Prespecified Therapeutic Anti- Factor Xa Levels
Description
Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. Percentage of participants who achieved the prespecified level during the dose adjustment phase were reported in this outcome measure.
Time Frame
Day 1 to 7 in dose adjustment phase
Title
Number of Participants With New or Progressive Symptomatic Venous Thromboembolism (VTE)
Description
Symptomatic VTE defined as new or progressive signs and symptoms as judged by the investigator including but not limited to: objective swelling, pain or tenderness, pitting edema, erythema or cyanosis. Progression of VTE: Progression of clot burden in terms of severity of occlusion, or involvement of new venous segments at any time after the initial diagnosis.
Time Frame
Baseline up to 28 days after the last dose of study drug (up to Day 132)
Title
Time to First Occurrence of Symptomatic Recurrent Venous Thromboembolism (VTE)
Description
It was defined as the time interval (in days) between date of first study treatment and date of documentation of first VTE. VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes PE. When a blood clot breaks, loose and travels in the blood, this is called VTE. VTE was confirmed by at least one radiographic test and was defined as any new or progressive VTE whose signs and symptoms (identified by the investigator) included: objective swelling or tenderness, pitting edema, erythema or cyanosis.
Time Frame
Baseline up to 28 days after the last dose of study drug (up to Day 132)
Title
Percentage of Participants With Clinical Response of Progression, Regression, Resolution and No Change in Venous Thromboembolism (VTE)
Description
VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. PE is a blood clot in the lungs. Clinical response of progression was defined as progression of clot burden in terms of severity of occlusion, or involvement of new venous segments at any time after the initial diagnosis. Clinical response of regression: Regressed clot burden utilizing the same imaging modality as the screening visit. Clinical response of resolution: Thrombus resolution of the qualifying event measured by repeat imaging at the end of study (EOS) visit.
Time Frame
Baseline up to 28 days after the last dose of study drug (up to Day 132)
Title
Percentage of Participants With Major and Minor Bleeding Event
Description
A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: fatal bleeding, bleeding accompanied by a decrease in hemoglobin of at least 2 grams per deciliter 24 hours, Overt bleeding deemed by the attending physician to necessitate permanent discontinuation of trial medication, Overt bleeding deemed by the attending physician to be unrelated to the participant's underlying condition and accompanied by blood product administration or bleeding occurred at a critical site (intraocular, intracranial, retroperitoneal). A bleeding event was considered as minor if it was clinically overt but not meeting the criteria for major or clinically relevant no major bleeding (bleeding resulting in any medical or surgical interventions but which did not meet the criteria for major bleeding).
Time Frame
Baseline up to 28 days after the last dose of study drug (up to Day 132)
Title
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 28 days after the last dose of study drug (up to Day 132) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.
Time Frame
Baseline up to 28 days after the last dose of study drug (up to Day 132)
Title
Number of Participants With Laboratory Abnormalities
Description
Criteria:hematology:hemoglobin, hematocrit, erythrocytes less than(<)0.8*lower limit of normal(LLN), platelets <0.5*LLN >1.75*upper limit of normal (ULN),leukocytes <0.6* LLN >1.5* ULN, lymphocytes, lymphocytes/Leukocytes, neutrophils, neutrophils/leukocytes <0.8* LLN >1.2* ULN, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes monocytes monocytes/leukocytes >1.2*ULN, activated partial thromboplastin time, prothrombin time, prothrombin international normalized ratio >1.1* ULN. Clinical chemistry: bilirubin >1.5*ULN, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, alkaline phosphatase >3.0*ULN, protein, albumin <0.8* LLN >1.2* ULN, blood urea nitrogen, creatinine >1.3* ULN, sodium <0.95*LLN >1.05*ULN, potassium, chloride, calcium, magnesium <0.9* LLN >1.1* ULN, phosphate <0.8* LLN >1.2* ULN, glucose <0.6*LLN >1.5*ULN, estimated(est) creatinine clearance, est GFR modified and bedside schwartz, >1.0* ULN. Urinalysis: creatinine >1.0*ULN.
Time Frame
Baseline up to 104 days
Title
Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSBP) in Participants
Time Frame
Baseline, Day 1, Day 2, Day 30, Day 60, Day 90
Title
Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants
Description
Heart rate and pulse rate of participants were measured in terms of beats per minute.
Time Frame
Baseline, Day 1, Day 2, Day 30, Day 60, Day 90
Title
Absolute Values of Height of Participants
Time Frame
Baseline, Day 1, Day 2, Day 30, Day 60, Day 90
Title
Absolute Values of Weight of Participants
Time Frame
Baseline, Day 1, Day 2, Day 30, Day 60, Day 90
Title
Absolute Values of Respiratory Rate of Participants
Description
Respiratory rate was defined as the number of breaths per minute.
Time Frame
Baseline, Day 1, Day 2, Day 30, Day 60, Day 90
Title
Absolute Values of Body Temperature of Participants
Time Frame
Baseline, Day 1, Day 2, Day 30, Day 60, Day 90
Title
Absolute Values of Body Length of Participants
Time Frame
Baseline, Day 1, Day 2, Day 30, Day 60, Day 90
Title
Number of Participants With Physical Examination Abnormalities of Participants
Description
Physical examinations included head, eyes, ears, nose, throat, neck, heart, chest, lungs, abdomen, extremities, skin, neurological status and general appearance. Abnormality in physical examination was based on investigator's discretion. Only those categories in which at least 1 participant had abnormality were reported.
Time Frame
Screening, Visit 2 (Baseline), Visit 3 (Day 1), Visit 4 (Day 2), Visit 5 (Day 30), Visit 6 (Day 60), Visit 7 (Day 90)
Title
Time to First Occurrence of Major Bleeding Event
Description
Time to first occurrence of major bleeding event was defined as the time interval (in days) between date of first study treatment and date of documentation of first major bleeding event. A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: fatal bleeding, bleeding accompanied by a decrease in hemoglobin of at least 2 grams per deciliter, overt bleeding deemed by the attending physician to necessitate permanent discontinuation of trial medication, overt bleeding deemed by the attending physician to be unrelated to the participant's underlying condition and accompanied by blood product administration, bleeding occurred at a critical site (intraocular, intracranial, retroperitoneal or intraspinal).
Time Frame
Baseline up to 28 days after the last dose of study drug (up to Day 132)
Title
Percentage of Participants Who Remained Within Prespecified Therapeutic Anti-Factor Xa Levels at Day 30, 60 and 90 in Follow up Phase
Description
Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. The percentage of participants who had anti factor-Xa levels within the prespecified therapeutic range at Day 30, 60 and 90 during the follow up phase were reported in this outcome measure.
Time Frame
Day 30, Day 60, Day 90 in follow up phase
Title
Percentage of Participants With Anti-Factor Xa Levels Outside the Prespecified Range at Day 30, 60 and 90 in Follow up Phase
Description
Prespecified therapeutic anti-factor Xa range was 0.5-1.0 IU/mL. The percentage of participants who had anti-factor Xa levels outside the prespecified therapeutic range at Day 30, 60 and 90 during the follow up phase were reported in this outcome measure.
Time Frame
Day 30, Day 60, Day 90 in follow-up phase
Title
Maintenance Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Levels
Description
Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. Cumulative data for day 1 to 7 has been reported.
Time Frame
4 hours post-dose at each Day 1 to 7 in dose adjustment phase
Title
Time to Achieve Prespecified Therapeutic Anti- Factor Xa Levels
Description
Time to achieve the target range (prespecified therapeutic anti- factor Xa levels) was defined as the number of days from the first dose of study drug to the final dose that achieves the target anti-factor Xa level. Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. Cumulative data of Day 1 to 7 is reported.
Time Frame
Day 1 to 7 in dose adjustment phase
Title
Number of Dose Adjustments Required to Achieve Prespecified Therapeutic Anti-Xa Levels
Description
During dose adjustment phase, doses were adjusted according to prespecified therapeutic anti-Xa levels in order to achieve target prespecified therapeutic anti-factor Xa levels (0.5 to 1.0 IU/mL). Number of dose adjustments which were done within the specified time window of up to 4 hours post dose on all days (1 to 7) to achieve the prespecified therapeutic anti-Xa levels are reported.
Time Frame
4 hours post-dose at each Day 1 to 7 in dose adjustment phase
Other Pre-specified Outcome Measures:
Title
Total Body Clearance of Dalteparin
Description
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed.
Time Frame
4 hours post-dose at each Day 1 to 7 in dose adjustment phase
Title
Volume of Distribution of Dalteparin
Description
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Time Frame
4 hours post-dose at each Day 1 to 7 in dose adjustment phase
Title
Absorption Rate Constant (Ka) of Dalteparin
Time Frame
4 hours post-dose at each Day 1 to 7 in dose adjustment phase

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Wolfson Children's Hospital
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Investigational Drug Service Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Tampa General Hospital Center of Research Excellence
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
St. Joseph's Children's Hospital of Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Children's Mercy Hospitals and Clinics
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
El Paso Children's Hospital
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
Texas Tech University Health Sciences Center El Paso
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
Texas Children's Cancer and Hematology Centers
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Children's Hospital Investigational Pharmacy Services
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Sykehusapoteket Oslo
City
Oslo
ZIP/Postal Code
0372
Country
Norway
Facility Name
Oslo universitetssykehus HF
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Facility Name
FSBEI HE Kazan SMU of Minzdrav Russia
City
Kazan
State/Province
Republic Tatarstan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
SAHI "Children's Republican Clinical Hospital of the Ministry of
City
Kazan
State/Province
Republic Tatarstan
ZIP/Postal Code
420138
Country
Russian Federation
Facility Name
SBHI of Moscow city Morozovskaya Children City Clinical Hospital of Moscow city
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
Facility Name
Lekarna, Univerzitetni klinicni center Ljubljana
City
Ljubljana
ZIP/Postal Code
SI-1000
Country
Slovenia
Facility Name
Pediatricna klinika, Univerzitetni Klinicni Center Ljubljana
City
Ljubljana
ZIP/Postal Code
SI-1000
Country
Slovenia
Facility Name
Hospital HM Universitario Monteprincipe Servicio de Farmacia
City
Boadilla del Monte
State/Province
Madrid
ZIP/Postal Code
28660
Country
Spain
Facility Name
Hospital HM Universitario Monteprincipe
City
Boadilla del Monte
State/Province
Madrid
ZIP/Postal Code
28660
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
35678616
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.
Results Reference
derived
PubMed Identifier
32827160
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=FRAG-A001-201&StudyName=A%20Three%20Month%20Prospective%20Open%20Label%20Study%20Of%20Therapy%20With%20Fragmin%20%28registered%29%20%28dalteparin%20Sodium%20Injection%29%20In%20Children%20With%20Venous%20Thromboembolism%20With%20Or%20Without%20Malignancies
Description
To obtain contact information for a study center near you, click here.
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=FRAG-A001-201&StudyName=A+Three+Month+Prospective+Open+Label+Study+Of+Therapy+With+Fragmin%28registered%29+%28dalteparin+Sodium+Injection%29+In+Children+With+Venous+Thromboembolism+With+Or+Without+Malignancies
Description
To obtain contact information for a study center near you, click here.

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Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients

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