Liver TransplantationPhase 2NCT02739412

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

A Phase 2 study testing Interleukin-2 in people with Liver Transplantation, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Liver Transplantation
What is being tested?: Interleukin-2
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: Nov 2016to Jul 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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,

Show all 14Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215

Other trials in United States

About this study

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

Read the detailed description

A common complication of organ transplantation is 'rejection' of the transplanted organ. This occurs when the body's immune system tries to attack (or reject) the transplanted organ.

Drugs known as immunosuppressants (anti-rejection medications) are prescribed for patients after transplantation to prevent rejection. But, anti-rejection medications are associated with significant side effects including high blood pressure, high blood sugars, and high cholesterol - all of which may increase the risk of heart and vascular complications. Anti-rejection medications also increase the long-term risk of some types of cancer.

Sometimes, liver transplant patients who stop taking anti-rejection medications do not experience rejection of their transplanted liver and the liver keeps working. These patients are said to "tolerate" the transplanted liver, and this condition is referred to as "tolerance". Doctors are working to learn more about why some liver transplant patients develop tolerance after receiving a transplant, while others do not.

Studies have shown that patients who develop "tolerance" have an increase in a type of immune cell called regulatory T-cells or "Tregs". This means Tregs may be important in preventing rejection of a transplanted organ.

Studies have also shown that a human cytokine (a type of protein), called interleukin-2 (IL-2) aids in increasing the number of Treg cells in the body, and IL-2 has been given to patients to successfully treat disorders of the immune system such as graft vs host disease - a serious condition sometimes seen in patients after bone marrow transplantation.

The purpose of this investigation is to study if 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.

In addition, investigators will learn about the kinds of side effects low dose IL-2 will cause and how severe those side effects will be.

Conditions: Liver Transplantation
Being tested: Interleukin-2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Interleukin-2Biological
Also called IL-2, Aldesleukin, Proleukin
Subjects will self-administer low dose IL-2 as subQ injection (0.30 MIU per meter squared body surface area) for 4 weeks.

Study groups in NCT02739412
Study group	Role	What they receive
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. Receives: Biological: Interleukin-2

What is being measured

The primary outcome is the main question the study is designed to answer.

Regulatory T-Cell Count
Peripheral Blood Mononuclear Cell Flow Cytometry
Measured: baseline, week 2, week 4, week8, week12
% Increase in CD4 Tregs
% CD4 T Regs were measured at several time points after IL-2 administration.
Measured: baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks

Secondary outcomes (1)

Differential Immune Cell Count
Peripheral Blood Mononuclear Cell Flow Cytometry
Measured: baseline, 2 weeks, 4 weeks, 8 weeks, 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2016Jul 2022

First posted15 Apr 2016 (estimated)
Study startNov 2016
Primary completionJul 2022
Study completionJul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Liver TransplantationStudies of the same condition, open and under way.
More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02739412
Sponsor's protocol ID: 2016P000086
Status last verified: Jan 2026
First submitted: 5 Apr 2016
Last updated: 13 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Liver Transplantation trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Low Dose, Subcutaneous Interleukin-2 (IL-2) to Expand Endogenous Regulatory T-Cells in Liver Transplant Recipients
ClinicalTrials.gov ID: NCT02739412
Acronym / sponsor ID: 2016P000086
Conditions: Liver Transplantation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: Beth Israel Deaconess Medical CenterUniversity, hospital or other
Study start: Nov 2016 (actual)
Primary completion: Jul 2022 (actual)
Study completion: Jul 2022 (actual)
First posted: 15 Apr 2016 (estimated)
Results: Posted 13 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

A common complication of organ transplantation is 'rejection' of the transplanted organ. This occurs when the body's immune system tries to attack (or reject) the transplanted organ.

In addition, investigators will learn about the kinds of side effects low dose IL-2 will cause and how severe those side effects will be.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Interleukin-2	Experimental	Biological: Interleukin-2IL-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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (14 listed)

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,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Interleukin-2Also: IL-2, Aldesleukin, ProleukinSubjects will self-administer low dose IL-2 as subQ injection (0.30 MIU per meter squared body surface area) for 4 weeks.	Biological	Interleukin-2

Primary outcome

Regulatory T-Cell Count
Time frame: baseline, week 2, week 4, week8, week12
Peripheral Blood Mononuclear Cell Flow Cytometry
% Increase in CD4 Tregs
Time frame: baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks
% CD4 T Regs were measured at several time points after IL-2 administration.

1 secondary outcome

Differential Immune Cell Count
Time frame: baseline, 2 weeks, 4 weeks, 8 weeks, 12 Weeks

Results and safety

Results posted to the registry on 13 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Study Medication Arm	6	5

Primary outcome: Regulatory T-Cell Count

Time frame: baseline, week 2, week 4, week8, week12. Median (Inter-Quartile Range). Unit: percentage of PBMC

Measure	Open Label. Active Study Treatment Arm n = 5
Baseline CD4Tred (%PBMC)	0.44 (0.27 to 0.75)
Wk2 CD4Treg (%PBMC)	3.71 (2.95 to 4.48)
Wk4 CD4Treg (%PBMC)	3.57 (2.53 to 3.59)
Wk8 CD4Treg (%PBMC)	0.6 (0.42 to 1.37)
Wk12 CD4Treg (%PBMC)	0.64 (0.44 to 1.28)

Open Label. Active Study Treatment Arm: p < 0.01, ANOVA

Population analysed: The efficacy analysis was performed on 5 patients. 1 patient withdrew from the study due to an adverse event before any efficacy data was obtained.6 patients were enrolled, 66% male with a median age of 54 years. Median time from transplant was 2.8 years. Five patients were on tacrolimus monotherapy and 1 patients was on tacrolimus and mycophenolate mofetil.

Primary outcome: % Increase in CD4 Tregs

Time frame: baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks. Median (Inter-Quartile Range). Unit: percentage of CD4 T cells

Measure	Active Study Medication Arm n = 5
Baseline CD4Treg (%CD4Tcells)	2.13 (1.04 to 3.12)
Wk2 CD4Treg (%CD4Tcells)	13.15 (11.53 to 19.02)
Wk4 CD4Treg (%CD4Tcells)	11.93 (8.88 to 15.94)
Wk8 CD4Treg(%CD4Tcells)	2.79 (1.51 to 5.18)
Wk12 CD4Treg (%CD4Tcells)	2.63 (1.75 to 4.94)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 36 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Study Medication Arm	1 of 6 (16.7%)	6 of 6 (100%)	0 of 6

Limitations and caveats (from the sponsor): The analysis for phenotypic T cell exhaustion was not performed due to inadequate remaining peripheral blood mononuclear cells on all study participants.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Liver Transplantation

Not yet recruitingObservational study
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Not yet recruiting
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Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael P Curry, MD principal investigator

Beth Israel Deaconess Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Interleukin-2 in people with Liver Transplantation, run by Beth Israel Deaconess Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Regulatory T-Cell Count (time frame: baseline, week 2, week 4, week8, week12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02739412.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.