Safety, Efficacy of Eglandin® in Living Donor Liver Transplanted Patient (PROVISION)

Evidence of Liver Transplantation Clinical Trial

— PROVISION  

Official title:

Open-label, Single Center, Randomized Clinical Trial to Evaluate Safety, Efficacy of Eglandin® (Alprostadil) 360㎍, 720㎍ in Living Donor Liver Transplanted Patient

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02350218
• Other study ID #: LSI-2014-0624
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 2015
• Est. completion date: December 2018

Study information

• Verified date: July 2018
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 76
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Primary living donor liver transplantation

2. Patient received modified right lobe graft

3. Aged between 19 to 65 years

4. Informed consent

Exclusion Criteria:

1. ABO incompatibility

2. Dual liver transplant patient from 2 donors

3. History of liver transplantation or other organ transplantation

4. Transplantation of other organ(s) at the time of liver transplantation

5. Use of artificial liver device prior to liver transplantation

6. UNOS status ?or ?A

7. History of malignant tumor within 5 years

8. Not included in Milan liver transplant criteria for hepatocellular carcinoma

9. Patient with WBC < 2,000/mm3 or ANC < 900/mm3 or platelet < 30,000/mm3 at the time of screening

10. Patient exposed to severe systemic infection requiring treatment

11. Positive response for HIV in either donor or recipient

12. Prior administration of other investigational product within 30 days (or 5 times the half life) from date of screening

13. Women of childbearing age without effective contraception, breast feeding and pregnant women

14. Substance abuser, patient with metal disorder, and otherwise legally not eligible patient

15. Not eligible to participate at discrete of study investigator

Related Conditions & MeSH terms

• Evidence of Liver Transplantation

Intervention

Drug:
• Eglandin
Inject Eglandin 360? or 720? for 14 days in living donor liver transplanted patient

Locations

Country	Name	City	State
Korea, Republic of	Korea, Republic of	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak AST level within 7 days of Eglandin administration		7 days
Secondary	Area Under the Curve (AUC) of serum AST level within 5 days of Eglandin administration		5 days
Secondary	Absolute and relative (percent) change in peak AST level within 7 days of Eglandin administration from baseline		7 days
Secondary	Peak ALT levels within 7 days of Eglandin administration		7 days
Secondary	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		7th, 14th, 60th, and 120th day from first dose of Eglandin administration
Secondary	Change in total bilirubin/AST/ALT from baseline at 7th, 14th, 30th, and 60th day from first dose of Eglandin administration		7th, 14th, 30th, and 60th day from first dose of Eglandin administration
Secondary	Peak total bilirubin levels within 7, 14, 30 and 60 days from first dose of Eglandin administration		7, 14, 30 and 60 days from first dose of Eglandin administration
Secondary	Time to total bilirubin recovery (within reference range)		day 2~14, day 30, 60,90, 120,150,180 from first dose of Eglandin administration
Secondary	Transplant liver survival rate on Day 180		Day 180
Secondary	Incidence of hepatic artery/vein/portal thrombosis on Day 180		Day 180
Secondary	Safety (other laboratory test, vital sign, adverse event) evaluation		All visit(Screening, baseline, day 2~14, day 30, 60,90, 120,150,180)