Pharmacokinetic Study of Lipo-PGE1 for Prevention of VOD After HSCT
NCT ID: NCT02338440
Last Updated: 2021-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
30 participants
INTERVENTIONAL
2015-01-31
2021-12-31
Brief Summary
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Prostaglandin E1 (PGE1) have been reported to prevent and relieve the severity of VOD by Gluckman et al.. Lipo-PGE1 is a transporter of PGE1, which is superior in concentrating PGE1 and acts for prolonged time. Because of the prolonged effective time, lipo-PGE1 acts comparable effects by 1/4\~1/8 of PGE1 dose. Empirically, pediatric HSCT centers adopt lipo-PGE1 in dose of 1 mcg/kg/day (0.042 mcg/kg/hr), which is 1/7 of the dose recommended by Gluckman, et al. This prospective study will investigate the concentration of lipo-PGE1 with preventive lipo-PGE1 with empirical dose (1 mcg/kg/day).
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Detailed Description
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Inclusion criteria
1. 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
2. Patients (or one of parents if patients age \< 19) should sign informed consent.
Exclusion criteria
1. Patient with heart failure.
2. Patient with bleeding (intracranial hemorrhage, gastrointestinal tract bleeding, hemoptysis).
3. History of hypersensitivity reaction as shock to lipo-PGE1.
4. Psychiatric disorder that would preclude compliance.
5. If the clinician decides that there is a condition improper for the clinical study.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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lipoprostaglandin E1 treatment arm
* lipoprostaglandin E1 1mcg/kg/day, continuous infusion
* lipoprostaglandin E1 1.5mcg/kg/day, continuous infusion (for patients with elevating total bilirubin, hepatomegaly, right upper quadrant abdominal pain, unexplained weight gain)
lipoprostaglandin E1
Blood sampling before administration (baseline), between 1 hour to 72 hours from administration (plateau 1), 72 hours after engraftment (plateau 2), when the clinician determine to do blood sampling because of change of kidney/liver function change (optional 1), 72 hours from the change of lipoprostaglandin E1 concentration change (optional 2)
Interventions
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lipoprostaglandin E1
Blood sampling before administration (baseline), between 1 hour to 72 hours from administration (plateau 1), 72 hours after engraftment (plateau 2), when the clinician determine to do blood sampling because of change of kidney/liver function change (optional 1), 72 hours from the change of lipoprostaglandin E1 concentration change (optional 2)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
2. Patients (or one of parents if patients age \< 19) should sign informed consent.
Exclusion Criteria
2. Patient with bleeding (intracranial hemorrhage, gastrointestinal tract bleeding, hemoptysis).
3. History of hypersensitivity reaction as shock to lipo-PGE1.
4. Psychiatric disorder that would preclude compliance.
5. If the clinician decides that there is a condition improper for the clinical study.
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Principal Investigators
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Hyoung Jin Kang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University College of Medicine
Locations
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Seoul National University Hospital
Seoul, Chongno-gu, South Korea
Countries
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Other Identifiers
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SNUCH-HSCT-lipoPGE1
Identifier Type: -
Identifier Source: org_study_id
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