Phase 2
N=38
Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients
Venous Thromboembolism
Bottom Line
View on ClinicalTrials.gov: NCT00952380 ↗Enrolled (actual)
38
Serious AEs
55.3%
Results posted
Apr 2019
Primary outcome: Primary: Median Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Level — 125 IU/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- dalteparin (Drug)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Level |
125 | — |
| SECONDARY Percentage of Participants Who Achieved Prespecified Therapeutic Anti- Factor Xa Levels |
0; 100.0; 100.0; 100.0; 85.0 | — |
| SECONDARY Number of Participants With New or Progressive Symptomatic Venous Thromboembolism (VTE) |
0; 0; 1; 0 | — |
| SECONDARY Time to First Occurrence of Symptomatic Recurrent Venous Thromboembolism (VTE) |
NA | — |
| SECONDARY Percentage of Participants With Clinical Response of Progression, Regression, Resolution and No Change in Venous Thromboembolism (VTE) |
0; 0; 0; 0; 0; 12.5 | — |
| SECONDARY Percentage of Participants With Major and Minor Bleeding Event |
0; 50.0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
1; 2; 7; 7; 19; 0 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities |
1; 2; 8; 5; 19 | — |
| SECONDARY Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSBP) in Participants |
101.00; 50.00; 110.50; 96.00; 117.50; 97.00 | — |
| SECONDARY Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants |
148.00; 146.00; 115.00; 70.00; 146.00; 142.00 | — |
| SECONDARY Absolute Values of Height of Participants |
54.00; 55.00; 110.00; 133.00; 166.00; 54.00 | — |
| SECONDARY Absolute Values of Weight of Participants |
4.05; 3.93; 18.78; 36.60; 60.00; 4.17 | — |
| SECONDARY Absolute Values of Respiratory Rate of Participants |
35.00; 25.00; 24.00; 20.00; 20.00; 34.00 | — |
| SECONDARY Absolute Values of Body Temperature of Participants |
36.60; 36.70; 36.50; 37.00; 36.80; 36.70 | — |
| SECONDARY Absolute Values of Body Length of Participants |
54; 55; 100; 172; 54; 55 | — |
| SECONDARY Number of Participants With Physical Examination Abnormalities of Participants |
0; 1; 2; 0; 2; 0 | — |
| SECONDARY Time to First Occurrence of Major Bleeding Event |
NA | — |
| SECONDARY Percentage of Participants Who Remained Within Prespecified Therapeutic Anti-Factor Xa Levels at Day 30, 60 and 90 in Follow up Phase |
100.0; 100.0; 33.3; 93.3; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With Anti-Factor Xa Levels Outside the Prespecified Range at Day 30, 60 and 90 in Follow up Phase |
0; 0; 66.7; 6.7; 0; 0 | — |
| SECONDARY Maintenance Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Levels |
207.50; 141.85; 132.40; 115.06 | — |
| SECONDARY Time to Achieve Prespecified Therapeutic Anti- Factor Xa Levels |
4.5; 3.0; 2.0; 2.0 | — |
| SECONDARY Number of Dose Adjustments Required to Achieve Prespecified Therapeutic Anti-Xa Levels |
3.5; 0.5; 0.0; 0.0 | — |
Summary
Three month treatment of acute VTE with Fragmin in pediatric cancer patients
Eligibility Criteria
Inclusion Criteria
-
Exclusion Criteria
-
Data sourced from ClinicalTrials.gov (NCT00952380). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.