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Could a tiny dose of IL-2 help liver transplant patients ditch heavy drugs?

NCT ID NCT02739412

Disease control Sponsor: Beth Israel Deaconess Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether very low doses of interleukin-2 (IL-2), given as shots under the skin for 4 weeks, could increase regulatory T-cells (Tregs) in liver transplant recipients. The goal was to see if this could eventually allow patients to take fewer immunosuppressant drugs. Only 6 adults who had received a liver transplant 2-4 years earlier took part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Interleukin-2 (IL-2)
What this could lead to
If successful, this approach could help liver transplant patients rely less on strong immunosuppressant drugs, reducing side effects and improving long-term health.
What could go wrong
This was a very small, early-phase trial with only 6 participants, so results may not apply broadly. The treatment may not effectively control rejection, and risks like immune overactivation are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

6 people

The number who actually took part.

Started

Nov 2016

Finished

Jul 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: 1. Adult liver transplant recipients 2-4 years post transplantation 2. Male or female adult, age 18 - 65 years 3. Stable dosage of suppressant therapy for 1 month prior to study. Exclusion criteria: 1. Recipient of multiple transplants (including solid organ, stem-cell, and bone marrow) 2. Serum liver panel (ALT, AST, Alkaline Phosphatase and Total Bilirubin) \> 2 x ULN, 3. Serum creatinine \> 1.5 x ULN, 4. eGFR of \< 40 ml/min, 5. Detectable hepatitis viral load, 6. Abnormal ECG with clinically significant findings per study physician's judgement, 7. Active infection, 8. Presence or history of autoimmunity disorders, 9. Evidence of allograft rejection, 10. Liver biopsy or fibroscan evidence of advanced stage liver fibrosis (\> Stage 2 Fibrosis), 11. Presence or history of cardiac or pulmonary disease, 12. Pregnant or nursing (lactating) women, 13. Health condition precludes participation in trial at study physician's judgment, 14. Inability to give consent.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Liver transplantation

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

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