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

NCT02739412 | Completed Phase 2 Results

• 1 other identifier: 2016P000086
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Transplantation

Outcome Measures

Primary Outcomes (2)

• Regulatory T-Cell Count

  Peripheral Blood Mononuclear Cell Flow Cytometry

  baseline, week 2, week 4, week8, week12

• % Increase in CD4 Tregs

  % CD4 T Regs were measured at several time points after IL-2 administration.

  baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks

Secondary Outcomes (1)

• Differential Immune Cell Count

  baseline, 2 weeks, 4 weeks, 8 weeks, 12 Weeks

Other Outcomes (2)

• Kidney Function Serum Panel (> 1.5 x Upper Limit Normal)

  2 weeks, 4 weeks, 8 weeks, 12 weeks, 36 weeks

• Liver Function Serum Panel (> 2 x Upper Limit Normal)

  week 2, 4 week, week 8, week12, week36

Study Arms (1)

Interleukin-2

EXPERIMENTAL

IL-2 (Interleukin-2; Aldesleukin; Proleukin) administered daily as a single subcutaneous injection 0.30 MIU per meter squared body surface area for a duration of 4 weeks.

Biological: Interleukin-2

Interventions

Interleukin-2 BIOLOGICAL

Subjects will self-administer low dose IL-2 as subQ injection (0.30 MIU per meter squared body surface area) for 4 weeks.

Also known as: IL-2, Aldesleukin, Proleukin

Interleukin-2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Interventions

Interleukin-2; aldesleukin

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Limitations and Caveats

The analysis for phenotypic T cell exhaustion was not performed due to inadequate remaining peripheral blood mononuclear cells on all study participants.

Results Point of Contact

• Title: Michael Curry MD
• Organization: Beth Israel Deaconess Medical Center

mcurry@bidmc.harvard.edu

617-632-9852

Study Officials

• Michael P Curry, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: April 15, 2016
• Study Start: November 1, 2016
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: January 13, 2026
• Results First Posted: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)