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

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Veno-occlusive Disease; Child

Intervention: lipoprostaglandin E1 (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Hyoung Jin Kang, MD, PhD, Principal Investigator, Affiliation: Seoul National University College of Medicine

Overall contact:
Hyoung Jin Kang, MD, PhD, Phone: 02-2072-3443, Email: kanghj@snu.ac.kr

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).

Clinical Details

Official title: Pharmacokinetic Study of Lipo-PGE1 for Prevention of VOD After HSCT

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: pharmacokinetics of lipo-PGE1 (Lipo-PGE1 level (B, P1, P2, O1, O2))

Secondary outcome: Incidence of VOD after transplantation

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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Hyoung Jin Kang, MD, PhD, Phone: 02-2072-3443, Email: kanghj@snu.ac.kr

Seoul National University Hospital, Seoul, Chongno-gu, Korea, Republic of; Recruiting
Hyoung Jin Kang, MD, Ph.D, Phone: 82 2 2072 3304, Email: kanghj@snu.ac.kr
Additional Information

Starting date: January 2015
Last updated: January 15, 2015

Page last updated: August 23, 2015

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