Evidence of Liver TransplantationPhase 2PROVISIONNCT02350218
Safety, Efficacy of Eglandin® in Living Donor Liver Transplanted Patient (PROVISION)
A Phase 2 study testing Eglandin in people with Evidence of Liver Transplantation, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate superiority of Eglandin® (Alprostadil) 720㎍compared to 360㎍ in terms of safety, efficacy in living donor liver transplant patient, peak AST levels followed by Eglandin administration were assessed. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Evidence of Liver Transplantation
- What is being tested?
- Eglandin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2015to Dec 2018
- Phase
- Phase 2
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary living donor liver transplantation
- Patient received modified right lobe graft
- Aged between 19 to 65 years
- Informed consent
Who cannot join
- ABO incompatibility
- Dual liver transplant patient from 2 donors
- History of liver transplantation or other organ transplantation
- Transplantation of other organ(s) at the time of liver transplantation
- Use of artificial liver device prior to liver transplantation
- UNOS status Ⅰor ⅡA
Show all 15Show fewer
- History of malignant tumor within 5 years
- Not included in Milan liver transplant criteria for hepatocellular carcinoma
- Patient with WBC < 2,000/mm3 or ANC < 900/mm3 or platelet < 30,000/mm3 at the time of screening
- Patient exposed to severe systemic infection requiring treatment
- Positive response for HIV in either donor or recipient
- Prior administration of other investigational product within 30 days (or 5 times the half life) from date of screening
- Women of childbearing age without effective contraception, breast feeding and pregnant women
- Substance abuser, patient with metal disorder, and otherwise legally not eligible patient
- Not eligible to participate at discrete of study investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Single Center, Randomized Clinical Trial to Evaluate Safety, Efficacy of Eglandin® (Alprostadil) 360㎍, 720㎍ in Living Donor Liver Transplanted Patient
The purpose of this study is to evaluate superiority of Eglandin® (Alprostadil) 720㎍compared to 360㎍ in terms of safety, efficacy in living donor liver transplant patient, peak AST levels followed by Eglandin administration were assessed.
- Conditions
- Evidence of Liver Transplantation
- Being tested
- Eglandin
- Keywords
- Transplantation, Living donor, Eglandin, Alprostadil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EglandinDrug
Also called Alprostadil
Inject Eglandin 360㎍ or 720㎍ for 14 days in living donor liver transplanted patient
| Study group | Role | What they receive |
|---|---|---|
| Eglandin 720㎍ | Experimental | Eglandin® (Alprostadil) 720㎍ Receives: Drug: Eglandin |
| Eglandin 360㎍ | Active comparator | Eglandin® (Alprostadil) 360㎍ Receives: Drug: Eglandin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak AST level within 7 days of Eglandin administration
Measured: 7 days
Secondary outcomes (10)
Area Under the Curve (AUC) of serum AST level within 5 days of Eglandin administration
Measured: 5 days
Absolute and relative (percent) change in peak AST level within 7 days of Eglandin administration from baseline
Measured: 7 days
Peak ALT levels within 7 days of Eglandin administration
Measured: 7 days
Change in blood flow rate of hepatic artery/vein/portal from baseline at 7th, 14th, 60th, and 120th day from first dose of Eglandin administration
Measured: 7th, 14th, 60th, and 120th day from first dose of Eglandin administration
Change in total bilirubin/AST/ALT from baseline at 7th, 14th, 30th, and 60th day from first dose of Eglandin administration
Measured: 7th, 14th, 30th, and 60th day from first dose of Eglandin administration
Peak total bilirubin levels within 7, 14, 30 and 60 days from first dose of Eglandin administration
Measured: 7, 14, 30 and 60 days from first dose of Eglandin administration
Time to total bilirubin recovery (within reference range)
Measured: day 2~14, day 30, 60,90, 120,150,180 from first dose of Eglandin administration
Transplant liver survival rate on Day 180
Measured: Day 180
Incidence of hepatic artery/vein/portal thrombosis on Day 180
Measured: Day 180
Safety (other laboratory test, vital sign, adverse event) evaluation
Measured: All visit(Screening, baseline, day 2~14, day 30, 60,90, 120,150,180)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evidence of Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giwon Song, Asan Medical Center
- Investigators
- Giwon Song, Professor, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350218
- Sponsor's protocol ID
- LSI-2014-0624
- Acronym
- PROVISION
- Status last verified
- Jul 2018
- First submitted
- 20 Jan 2015
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Single Center, Randomized Clinical Trial to Evaluate Safety, Efficacy of Eglandin® (Alprostadil) 360㎍, 720㎍ in Living Donor Liver Transplanted Patient
- ClinicalTrials.gov ID
- NCT02350218
- Acronym / sponsor ID
- PROVISION / LSI-2014-0624
- Conditions
- Evidence of Liver Transplantation
- Keywords
- Transplantation, Living donor, Eglandin, Alprostadil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 29 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.
The purpose of this study is to evaluate superiority of Eglandin® (Alprostadil) 720㎍compared to 360㎍ in terms of safety, efficacy in living donor liver transplant patient, peak AST levels followed by Eglandin administration were assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eglandin 720㎍ | Experimental | Drug: EglandinEglandin® (Alprostadil) 720㎍ |
| Eglandin 360㎍ | Active comparator | Drug: EglandinEglandin® (Alprostadil) 360㎍ |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary living donor liver transplantation
- Patient received modified right lobe graft
- Aged between 19 to 65 years
- Informed consent
Key exclusion criteria (15 listed)
- ABO incompatibility
- Dual liver transplant patient from 2 donors
- History of liver transplantation or other organ transplantation
- Transplantation of other organ(s) at the time of liver transplantation
- Use of artificial liver device prior to liver transplantation
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 |
|---|---|---|
| EglandinAlso: AlprostadilInject Eglandin 360㎍ or 720㎍ for 14 days in living donor liver transplanted patient | Drug | Eglandin 360㎍, Eglandin 720㎍ |
Primary outcome
Peak AST level within 7 days of Eglandin administration
Time frame: 7 days
10 secondary outcomes
Area Under the Curve (AUC) of serum AST level within 5 days of Eglandin administration
Time frame: 5 days
Absolute and relative (percent) change in peak AST level within 7 days of Eglandin administration from baseline
Time frame: 7 days
Peak ALT levels within 7 days of Eglandin administration
Time frame: 7 days
Change in blood flow rate of hepatic artery/vein/portal from baseline at 7th, 14th, 60th, and 120th day from first dose of Eglandin administration
Time frame: 7th, 14th, 60th, and 120th day from first dose of Eglandin administration
Change in total bilirubin/AST/ALT from baseline at 7th, 14th, 30th, and 60th day from first dose of Eglandin administration
Time frame: 7th, 14th, 30th, and 60th day from first dose of Eglandin administration
Peak total bilirubin levels within 7, 14, 30 and 60 days from first dose of Eglandin administration
Time frame: 7, 14, 30 and 60 days from first dose of Eglandin administration
Time to total bilirubin recovery (within reference range)
Time frame: day 2~14, day 30, 60,90, 120,150,180 from first dose of Eglandin administration
Transplant liver survival rate on Day 180
Time frame: Day 180
Incidence of hepatic artery/vein/portal thrombosis on Day 180
Time frame: Day 180
Safety (other laboratory test, vital sign, adverse event) evaluation
Time frame: All visit(Screening, baseline, day 2~14, day 30, 60,90, 120,150,180)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Individual participant dataSharing planned: No
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.
Giwon Song, Professor principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eglandin in people with Evidence of Liver Transplantation, run by Asan Medical Center 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 15 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 6 Jul 2018. 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 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.
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?
Peak AST level within 7 days of Eglandin administration (time frame: 7 days). 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 6 Jul 2018.