Efficacy of Low Dose, SubQ Interleukin-2 (IL-2) to Expand Endogenous Regulatory T-Cells in Liver Transplant Recipients

Completed · Phase 2

Conditions studied: Liver Transplantation

In brief

The purpose of this investigation is to study if very low dose IL-2, given to liver transplant patients by subcutaneous (under the skin) injections, over a 4 week period of time, will cause an increase in the number of Treg cells in the blood.

Key facts

Study ID

NCT02739412

Run by

Beth Israel Deaconess Medical Center

People needed

6

Starts

2016-11-01

Expected to finish

2022-07-01

Last updated by the study team

2026-01-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult liver transplant recipients 2-4 years post transplantation
• Male or female adult, age 18 - 65 years
• Stable dosage of suppressant therapy for 1 month prior to study.

You may not qualify if…

• Recipient of multiple transplants (including solid organ, stem-cell, and bone marrow)
• Serum liver panel (ALT, AST, Alkaline Phosphatase and Total Bilirubin) > 2 x ULN,
• Serum creatinine > 1.5 x ULN,
• eGFR of < 40 ml/min,
• Detectable hepatitis viral load,
• Abnormal ECG with clinically significant findings per study physician's judgement,
• Active infection,
• Presence or history of autoimmunity disorders,
• Evidence of allograft rejection,
• Liver biopsy or fibroscan evidence of advanced stage liver fibrosis (> Stage 2 Fibrosis),
• Presence or history of cardiac or pulmonary disease,
• Pregnant or nursing (lactating) women,
• Health condition precludes participation in trial at study physician's judgment,
• Inability to give consent.

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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