Trial Outcomes & Findings for DCreg in Living Donor Liver Transplantation (NCT NCT03164265)

NCT ID: NCT03164265

Last Updated: 2025-09-16

Results Overview

1\. Safety: Safety will be determined by assessing the percentage of subjects experiencing the following events: i) CTCAE Grade 4 or higher infusion reaction; ii) CTCAE Grade 4 or higher infection; iii) Malignancy other than non-melanoma skin cancer or HCC recurrence; iv) Rejection resulting in recipient death or retransplantation; v) Biopsy-proven severe acute rejection; vi) Any grade chronic rejection; vii) Non-surgical graft loss; viii) Recipient death;

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 16 participants
• Primary outcome timeframe: 6 years
• Results posted on: 2025-09-16

Participant Flow

Participant milestones

Measure	Study Group Prospectively enrolled living donor liver transplant recipients pre-op.
Overall Study STARTED	16
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Study Group Prospectively enrolled living donor liver transplant recipients pre-op.
Overall Study Physician Decision	3

Baseline Characteristics

DCreg in Living Donor Liver Transplantation

Baseline characteristics by cohort

Measure	Study Group n=13 Participants Prospectively enrolled living donor liver transplant recipients pre-op.
Age, Continuous	62 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 years

Population: living donor liver transplant recipients

1. Safety: Safety will be determined by assessing the percentage of subjects experiencing the following events: i) CTCAE Grade 4 or higher infusion reaction; ii) CTCAE Grade 4 or higher infection; iii) Malignancy other than non-melanoma skin cancer or HCC recurrence; iv) Rejection resulting in recipient death or retransplantation; v) Biopsy-proven severe acute rejection; vi) Any grade chronic rejection; vii) Non-surgical graft loss; viii) Recipient death;

Outcome measures

Measure	Study Group n=13 Participants Prospectively enrolled living donor liver transplant recipients pre-op.
Proportion of Safety Events	1 Participants

PRIMARY outcome

Timeframe: 2.5 years

Population: living donor liver transplant recipients

Proportion of patients able to achieve staged immunosuppression withdrawal with operational tolerance

Outcome measures

Measure	Study Group n=13 Participants Prospectively enrolled living donor liver transplant recipients pre-op.
Preliminary Efficacy	3 Participants

SECONDARY outcome

Timeframe: 6 years

Population: living donor liver transplant recipients.

DSA levels early (<6 weeks) and late (> 6 weeks) after transplantation

Outcome measures

Measure	Study Group n=13 Participants Prospectively enrolled living donor liver transplant recipients pre-op.
Donor Specific Antigen (DSA) Levels early DSA	3 Participants
Donor Specific Antigen (DSA) Levels late DSA	7 Participants
Donor Specific Antigen (DSA) Levels No DSA	3 Participants

SECONDARY outcome

Timeframe: from baseline to 4.5 years post transplantation

Population: living donor liver transplant recipients

Change in renal function measured by change in estimated glomerular filtration rate (eGFR)

Outcome measures

Measure	Study Group n=13 Participants Prospectively enrolled living donor liver transplant recipients pre-op.
Change in Renal Function	4.42 ml/min Standard Deviation 1.5

SECONDARY outcome

Timeframe: 1 year post-transplantation (prior to weaning) 4.5 years post transplantation

Population: living donor liver transplant recipients

Scale title: Short Form 36 (SF-36) Quality of Life questionnaire. Minimum and maximum values 0 to 100 higher scores indicates better health.

Outcome measures

Measure	Study Group n=13 Participants Prospectively enrolled living donor liver transplant recipients pre-op.
Change in Quality of Life Pain	-13.25 score on a scale Standard Deviation 21.35
Change in Quality of Life General health	-11.5 score on a scale Standard Deviation 20.42
Change in Quality of Life Physical functioning	-7.7 score on a scale Standard Deviation 21.82
Change in Quality of Life Role limitations due to physical health	-12.5 score on a scale Standard Deviation 29.46
Change in Quality of Life Role limitations due to emotional problems	-10 score on a scale Standard Deviation 41.73
Change in Quality of Life Energy and fatigue	-3.83 score on a scale Standard Deviation 7.76
Change in Quality of Life Emotional well-being	-12.4 score on a scale Standard Deviation 19.64
Change in Quality of Life Social functioning	-13.75 score on a scale Standard Deviation 30.31
Change in Quality of Life Health change	-25 score on a scale Standard Deviation 25

SECONDARY outcome

Timeframe: from baseline to 4.5 years post transplantation

Population: living donor liver transplant recipients

Outcome measures

Measure	Study Group n=13 Participants Prospectively enrolled living donor liver transplant recipients pre-op.
Change in Cardiovascular Risk Factors (Systolic Blood Pressure)	10.5 millimeters of Mercury (Hg) Standard Deviation 16.31

SECONDARY outcome

Timeframe: from baseline to 4.5 years

Population: living donor liver transplant recipients

Outcome measures

Measure	Study Group n=13 Participants Prospectively enrolled living donor liver transplant recipients pre-op.
Change in Cardiovascular Risk Factors (Triglycerides)	98.88 mg/dL Standard Deviation 141.3

Adverse Events

Study Group

Serious events: 0 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Study Group n=13 participants at risk Prospectively enrolled living donor liver transplant recipients pre-op.
Infections and infestations CMV viremia	15.4% 2/13 • Number of events 2 • 4.5 years same as clinical trials.gov
Infections and infestations Herpes Simplex virus	7.7% 1/13 • Number of events 1 • 4.5 years same as clinical trials.gov
Infections and infestations COVID infection	15.4% 2/13 • Number of events 2 • 4.5 years same as clinical trials.gov
Infections and infestations bacterial infection	23.1% 3/13 • Number of events 3 • 4.5 years same as clinical trials.gov
Infections and infestations oral candidiasis	7.7% 1/13 • Number of events 1 • 4.5 years same as clinical trials.gov

Additional Information

Dr. Angus Thomson

University of Pittsburgh

Phone: (412) 624-6392

Email: thomsonaw@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place