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Cytokine

Interleukin-2 for Liver Transplant

Phase 2
Waitlist Available
Led By Michael P Curry, MD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult liver transplant recipients 2-4 years post transplantation
Male or female adult, age 18 - 65 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial is testing whether a low dose of IL-2 given over 4 weeks will increase the number of Treg cells in the blood of liver transplant patients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Regulatory T-Cell Count
Secondary outcome measures
Differential Immune Cell Count
T-Cell Exhaustion Phenotyping
Other outcome measures
Kidney Function Serum Panel (> 1.5 x Upper Limit Normal)
Liver Function Serum Panel (> 2 x Upper Limit Normal)
Serious Adverse Events (SAEs)

Side effects data

From 2014 Phase 2 trial • 13 Patients • NCT01105650
100%
Neutropenic fever
100%
Chills
100%
Dyspnea
100%
Edema
67%
Hypotension
67%
Death NOS
67%
Fever
67%
Hypertension
67%
Hypoxia
33%
Double vision
33%
Foot pain
33%
Acute kidney injury
33%
Confusion/Disoriented
33%
Blurred vision
33%
Dizziness
33%
Atrial fibrillation
33%
Vestibular disorder
33%
Hearing loss
33%
Ascites
33%
Hearing impairmed
33%
Hallucinations
33%
Headache
33%
Rash/Desquamation
33%
Depressed level of consciousness
33%
Strange dreams
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2
Arm 1: CsA
Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2

Trial Design

1Treatment groups
Experimental Treatment
Group I: Interleukin-2Experimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aldesleukin
FDA approved

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
835 Previous Clinical Trials
13,006,523 Total Patients Enrolled
Michael P Curry, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~1 spots leftby Mar 2025