Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00952380
• Date of registration: 04/08/2009
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients
• Scientific 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
• Date of first enrolment: August 2009
• Target sample size: 38
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00952380
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Croatia, Germany, Norway, Poland, Romania, Russian Federation, Slovenia, Spain, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

-

Exclusion Criteria:

-



Age minimum: N/A
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Venous Thromboembolism

Intervention(s)

Drug: dalteparin

Primary Outcome(s)

Median Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Level [Time Frame: 4 hours post-dose at each Day 1 to 7 in dose adjustment phase]

Secondary Outcome(s)

Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants [Time Frame: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90]

Absolute Values of Weight of Participants [Time Frame: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90]

Maintenance Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Levels [Time Frame: 4 hours post-dose at each Day 1 to 7 in dose adjustment phase]

Time to First Occurrence of Major Bleeding Event [Time Frame: Baseline up to 28 days after the last dose of study drug (up to Day 132)]

Absolute Values of Body Temperature of Participants [Time Frame: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90]

Time to Achieve Prespecified Therapeutic Anti- Factor Xa Levels [Time Frame: Day 1 to 7 in dose adjustment phase]

Absolute Values of Body Length of Participants [Time Frame: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90]

Number of Participants With Laboratory Abnormalities [Time Frame: Baseline up to 104 days]

Percentage of Participants Who Remained Within Prespecified Therapeutic Anti-Factor Xa Levels at Day 30, 60 and 90 in Follow up Phase [Time Frame: Day 30, Day 60, Day 90 in follow up phase]

Percentage of Participants Who Achieved Prespecified Therapeutic Anti- Factor Xa Levels [Time Frame: Day 1 to 7 in dose adjustment phase]

Percentage of Participants With Major and Minor Bleeding Event [Time Frame: Baseline up to 28 days after the last dose of study drug (up to Day 132)]

Absolute Values of Height of Participants [Time Frame: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90]

Percentage of Participants With Clinical Response of Progression, Regression, Resolution and No Change in Venous Thromboembolism (VTE) [Time Frame: 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) [Time Frame: Baseline up to 28 days after the last dose of study drug (up to Day 132)]

Absolute Values of Respiratory Rate of Participants [Time Frame: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90]

Number of Participants With New or Progressive Symptomatic Venous Thromboembolism (VTE) [Time Frame: Baseline up to 28 days after the last dose of study drug (up to Day 132)]

Number of Participants With Physical Examination Abnormalities of Participants [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)]

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]

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Baseline up to 28 days after the last dose of study drug (up to Day 132)]

Percentage of Participants With Anti-Factor Xa Levels Outside the Prespecified Range at Day 30, 60 and 90 in Follow up Phase [Time Frame: Day 30, Day 60, Day 90 in follow-up phase]

Number of Dose Adjustments Required to Achieve Prespecified Therapeutic Anti-Xa Levels [Time Frame: 4 hours post-dose at each Day 1 to 7 in dose adjustment phase]

Secondary ID(s)

2016-000394-21

A6301094

FRAG-A001-201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 16/04/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00952380