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
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