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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02338440
Other study ID # SNUCH-HSCT-lipoPGE1
Secondary ID
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date January 2015
Est. completion date December 2021

Study information

Verified date March 2021
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Veno-occlusive disease (VOD) after hematopoietic stem cell transplantation (HSCT) remains the major complication. VOD occurs in 11-31% of pediatric HSCT and the mortality reaches up to 50%. 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).


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 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date December 2021
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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)

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul Chongno-gu

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary pharmacokinetics of lipo-PGE1 (Lipo-PGE1 level (B, P1, P2, O1, O2)) Lipo-PGE1 drug level of time points (B, P1, P2, O1, O2) baseline (pre-dose), 1 to 72 hours from starting continuous infusion of lipo-PGE1
Secondary Incidence of VOD after transplantation cumulative incidence of VOD until 3 months after transplantation until 3 months after transplantation
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