Pharmacokinetic Study of Lipo-PGE1 for Prevention of VOD After HSCT
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Child
- Veno-occlusive Disease
- Type
- Interventional
- Phase
- Phase 2Phase 3
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
Description
Primary Objective: To evaluate the pharmacokinetics of lipo-PGE1. Secondary objective: To evaluate the relation between lipo-PGE1 concentration and VOD occurrence, severity. Inclusion criteria Patients undergoing HSCT with high risk of VOD who cannot use low dose heparin. high risk of VOD : previous...
Primary Objective: To evaluate the pharmacokinetics of lipo-PGE1. Secondary objective: To evaluate the relation between lipo-PGE1 concentration and VOD occurrence, severity. Inclusion criteria Patients undergoing HSCT with high risk of VOD who cannot use low dose heparin. high risk of VOD : previous radiotherapy, liver function abnormality, children, conditioning regimen including busulfan or total body irradiation contraindication of heparin : low platelet count, bleeding tendency, allergy Patients (or one of parents if patients age < 19) should sign informed consent. Exclusion criteria Patient with heart failure. Patient with bleeding (intracranial hemorrhage, gastrointestinal tract bleeding, hemoptysis). History of hypersensitivity reaction as shock to lipo-PGE1. Psychiatric disorder that would preclude compliance. If the clinician decides that there is a condition improper for the clinical study.
Tracking Information
- NCT #
- NCT02338440
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Hyoung Jin Kang, MD, PhD Seoul National University College of Medicine
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