NCT02338440

Pharmacokinetic Study of Lipo-PGE1 for Prevention of VOD After HSCT

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Veno-occlusive Disease
• Child

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2015-01-01
• Primary completion: 2019-12-01
• Completion: 2021-12-01
• First posted: 2015-01-14
• Last updated: 2021-03-30

Locations

1 site across 1 country: South Korea