Clinical trial · Interventional
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
NCT00952380CI-TRIAL-00038116completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Three month treatment of acute VTE with Fragmin in pediatric cancer patients
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Venous Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dalteparin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single Arm
- description
- Single arm open-label
- interventionNames
- Drug: dalteparin
Primary outcomes (1)
- measure
- Median Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Level
- timeFrame
- 4 hours post-dose at each Day 1 to 7 in dose adjustment phase
- 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.
Secondary outcomes (21)
- measure
- Percentage of Participants Who Achieved Prespecified Therapeutic Anti- Factor Xa Levels
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- Exclusion Criteria: \-
References
Publications (2)
- DERIVEDHartman 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 35678616
- DERIVEDDamle 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 32827160