Phase 2 Completed N=6 Treatment

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

Liver Transplantation

Source: ClinicalTrials.gov NCT02739412 ↗

Enrolled (actual)

Serious AEs

16.7%

Results posted

Jan 2026

Primary outcomePrimary: Regulatory T-Cell Count — 0.44; 3.71; 3.57; 0.6 percentage of PBMC — p=< 0.01

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Regulatory T-Cell Count	0.44; 3.71; 3.57; 0.6; 0.64	< 0.01 sig
PRIMARY % Increase in CD4 Tregs	2.13; 13.15; 11.93; 2.79; 2.63	—
SECONDARY Differential Immune Cell Count	53.74; 57.05; 53.69; 58.00; 53.35; 25.59	—

Eligibility Criteria

Inclusion criteria

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.

Exclusion criteria

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02739412). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.