Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients

Pfizer

Status and phase: Completed; Phase 2

Conditions: Venous Thromboembolism

Treatments: Drug: dalteparin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00952380

A6301094 (Other Identifier)

FRAG-A001-201

2016-000394-21 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 38 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Single Arm

Other group

Description:

Single arm open-label

Treatment:

Drug: dalteparin