Pharmacokinetic Study of Lipo-PGE1 for Prevention of VOD After HSCT
Keywords
Abstract
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.
Dates
| Last Verified: | 03/31/2019 |
| First Submitted: | 12/29/2014 |
| Estimated Enrollment Submitted: | 01/10/2015 |
| First Posted: | 01/13/2015 |
| Last Update Submitted: | 04/04/2019 |
| Last Update Posted: | 04/07/2019 |
| Actual Study Start Date: | 12/31/2014 |
| Estimated Primary Completion Date: | 11/30/2019 |
| Estimated Study Completion Date: | 11/30/2019 |
Condition or disease
Intervention/treatment
Drug: lipoprostaglandin E1 treatment arm
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: lipoprostaglandin E1 treatment arm lipoprostaglandin E1 1mcg/kg/day, continuous infusion
lipoprostaglandin E1 1.5mcg/kg/day, continuous infusion (for patients with elevating total bilirubin, hepatomegaly, right upper quadrant abdominal pain, unexplained weight gain) | Drug: lipoprostaglandin E1 treatment arm 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) |
Eligibility Criteria
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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. |
Outcome
Primary Outcome Measures
1. pharmacokinetics of lipo-PGE1 (Lipo-PGE1 level (B, P1, P2, O1, O2)) [baseline (pre-dose), 1 to 72 hours from starting continuous infusion of lipo-PGE1]
Secondary Outcome Measures
1. Incidence of VOD after transplantation [until 3 months after transplantation]
