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

Child Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02338440
• Other study ID #: SNUCH-HSCT-lipoPGE1
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Child
• Veno-occlusive Disease

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