Veno-occlusive DiseasePhase 2/3NCT02338440
Pharmacokinetic Study of Lipo-PGE1 for Prevention of VOD After HSCT
A Phase 2/3 study testing lipoprostaglandin E1 in people with Veno-occlusive Disease and Child, run by Seoul National University Hospital at 1 site in South Korea.
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.. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Veno-occlusive Disease, Child
- What is being tested?
- lipoprostaglandin E1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2015to Dec 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
- Patients (or one of parents if patients age < 19) should sign informed consent.
Who cannot join
- Patient with heart failure.
- Patient with bleeding (intracranial hemorrhage, gastrointestinal tract bleeding, hemoptysis).
- History of hypersensitivity reaction as shock to lipo-PGE1.
- Psychiatric disorder that would preclude compliance.
- If the clinician decides that there is a condition improper for the clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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
- 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
- Patients (or one of parents if patients age < 19) should sign informed consent.
Exclusion criteria
- Patient with heart failure.
- Patient with bleeding (intracranial hemorrhage, gastrointestinal tract bleeding, hemoptysis).
- History of hypersensitivity reaction as shock to lipo-PGE1.
- Psychiatric disorder that would preclude compliance.
- If the clinician decides that there is a condition improper for the clinical study.
- Conditions
- Veno-occlusive Disease, Child
- Being tested
- lipoprostaglandin E1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lipoprostaglandin E1Drug
Also called Alostin
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)
| Study group | Role | What they receive |
|---|---|---|
| lipoprostaglandin E1 treatment arm | Experimental | * 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) Receives: Drug: lipoprostaglandin E1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacokinetics of lipo-PGE1 (Lipo-PGE1 level (B, P1, P2, O1, O2))
Lipo-PGE1 drug level of time points (B, P1, P2, O1, O2)
Measured: baseline (pre-dose), 1 to 72 hours from starting continuous infusion of lipo-PGE1
Secondary outcomes (1)
Incidence of VOD after transplantation
cumulative incidence of VOD until 3 months after transplantation
Measured: until 3 months after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2019
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Veno-occlusive DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hyoung Jin Kang, MD, PhD, Principal investigator, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338440
- Sponsor's protocol ID
- SNUCH-HSCT-lipoPGE1
- Status last verified
- Mar 2021
- First submitted
- 30 Dec 2014
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of Lipo-PGE1 for Prevention of VOD After HSCT
- ClinicalTrials.gov ID
- NCT02338440
- Acronym / sponsor ID
- SNUCH-HSCT-lipoPGE1
- Conditions
- Veno-occlusive Disease, Child
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 14 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- Patients (or one of parents if patients age < 19) should sign informed consent.
Exclusion criteria
- Patient with heart failure.
- Patient with bleeding (intracranial hemorrhage, gastrointestinal tract bleeding, hemoptysis).
- History of hypersensitivity reaction as shock to lipo-PGE1.
- Psychiatric disorder that would preclude compliance.
- If the clinician decides that there is a condition improper for the clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lipoprostaglandin E1 treatment arm | Experimental | Drug: lipoprostaglandin E1* 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing HSCT with high risk of VOD who cannot use low dose heparin.
- Patients (or one of parents if patients age < 19) should sign informed consent.
Key exclusion criteria (5 listed)
- Patient with heart failure.
- Patient with bleeding (intracranial hemorrhage, gastrointestinal tract bleeding, hemoptysis).
- History of hypersensitivity reaction as shock to lipo-PGE1.
- Psychiatric disorder that would preclude compliance.
- If the clinician decides that there is a condition improper for the clinical study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lipoprostaglandin E1Also: AlostinBlood 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) | Drug | lipoprostaglandin E1 treatment arm |
Primary outcome
pharmacokinetics of lipo-PGE1 (Lipo-PGE1 level (B, P1, P2, O1, O2))
Time frame: baseline (pre-dose), 1 to 72 hours from starting continuous infusion of lipo-PGE1
Lipo-PGE1 drug level of time points (B, P1, P2, O1, O2)
1 secondary outcome
Incidence of VOD after transplantation
Time frame: until 3 months after transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyoung Jin Kang, MD, PhD principal investigator
Seoul National University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing lipoprostaglandin E1 in people with Veno-occlusive Disease and Child, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pharmacokinetics of lipo-PGE1 (Lipo-PGE1 level (B, P1, P2, O1, O2)) (time frame: baseline (pre-dose), 1 to 72 hours from starting continuous infusion of lipo-PGE1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.