Other Clinical Trial - DCreg in Living Donor Liver Transplantation

Status Active, not recruiting

Clinical Trial Summary

Phase I/II, single center, prospective, open-label, non-controlled, non-randomized, interventional, cohort study in which low risk living donor liver transplant (LDLT) recipients will receive a single infusion of donor-derived DCreg 1 week prior to transplantation. All patients will be maintained on MPA and Tacrolimus (Tac) for the 1st 6 months after transplantation. At that time point, recipients meeting specific criteria will be slowly weaned off MPA per standard of care over a period of 6 months. Participants will then be evaluated for TAC weaning at 1 yr after transplantation. Those who meet specific criteria be weaned off Tac over 6 months . Successfully weaned participants who remain rejection-free will undergo 3 years of follow-up after the last dose of immunosuppression.

Clinical Trial Description

Phase I/II, single center, prospective, open-label, non-controlled, non-randomized, interventional, cohort study in which low risk living donor liver transplant (LDLT) recipients will receive a single infusion of donor-derived DCreg with concurrent mycophenolic acid (MPA) therapy (1/2 dose) 1 week prior to transplantation. All patients will be maintained on MPA and Tacrolimus (Tac) for the 1st 6 months after transplantation. At that time point, recipients meeting specific criteria (no rejection and permissive liver function tests (LFTs)) will be slowly weaned off MPA per standard of care over a period of 6 months. Participants will then be evaluated for TAC weaning at 1 yr after transplantation. Those who meet the criteria of no rejection and permissive LFTs will undergo a protocol liver biopsy and proceed to Tac weaning over 6 months if liver biopsy is permissive. Successfully weaned participants who remain rejection-free will undergo 3 years of follow-up after the last dose of immunosuppression. They will undergo a liver biopsy at 1 yr and 3 yrs after immunosuppression withdrawal. Participants who are removed from the study protocol at any time will return to standard of care but will continue to be followed by the study team and may undergo a liver biopsy at the end of the study (4.5 yrs after transplantation). For subjects who return to standard of care (on immunosuppression at end of study), the year 4.5 biopsy will be optional. ;

Study Design

Related Conditions & MeSH terms

Living Donor Liver Transplantation

Clinical Trial Details

NCT number	NCT03164265
Study type	Interventional
Source	University of Pittsburgh
Contact
Status	Active, not recruiting
Phase	Phase 1/Phase 2
Start date	August 30, 2017
Completion date	December 2024

View Details

See also
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Completed	`NCT05506020` - Application of ICG Fluorescence Cholangiography in Laparoscopic Living Donor Left Lateral Sectionectomy	N/A
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Recruiting	`NCT04909645` - A Comparison of Invasive and Non-invasive Measurement of CI and SVR in Liver Transplantation	N/A
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Completed	`NCT04184401` - Effect of Ascites Replacement Strategy on Time to 1st Flatus After LDLT	Phase 4
Completed	`NCT02990351` - Efficacy of Loco-regional Treatment for Hepatocellular Carcinoma Prior to Living Donor Liver Transplantation in Egypt	N/A
Active, not recruiting	`NCT04208919` - Delayed Infusion of DCreg in Living Donor Liver Transplantation	Phase 1/Phase 2
Completed	`NCT03773276` - Norepinephrine Boluses in Liver Transplantation	Phase 1/Phase 2
Completed	`NCT05010941` - Hypotension Prediction Index in Living Donor Liver Transplantation
Not yet recruiting	`NCT04943263` - A Comparison of Temperature Measurement During Living Donor Liver Transplantation	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.