CompletedPhase 1/2

DCreg in Living Donor Liver Transplantation

United States16 participantsStarted 2017-08-30

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Able to understand and provide informed consent;
✓. Male or female between the ages of 18-55;
✓. Meet all standard institutional and UNOS criteria for liver donation;
✓. For females of childbearing potential, a negative urine or serum pregnancy test;
✓. Negative for HIV (5th generation Test and NAT), HTLV-1, HTLV-2;(\*)
✓. Negative for hepatitis C (antibody and NAT), hepatitis B (surface antigen and NAT)(\*)

Exclusion criteria

✕. Between ages 18 and 75 years
✕. Undergoing de novo (first) liver transplant
✕. Female subjects of childbearing potential must have a negative pregnancy test upon study entry.
✕. Agreement to use contraception; according to the FDA Office of Women's Health (http://www.fda.gov/birthcontrol), there are a number of birth control methods that are more than 80% effective. Female participants of child-bearing potential must consult with their physician and determine the most suitable method(s) from this list to be used from the time that study treatment begins until 1 year after completion of immunosuppression withdrawal.

What they're measuring

Proportion of Safety Events

Timeframe: 6 years

Preliminary Efficacy

Timeframe: 2.5 years

Trial details

NCT IDNCT03164265

SponsorAngus W. Thomson PhD DSc

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-15

Results submitted2025-07-15

View on ClinicalTrials.gov More Living Donor Liver Transplantation trials