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

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ClinicalTrials.gov Identifier: NCT02739412
Recruitment Status : Recruiting
First Posted : April 15, 2016
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Curry, Beth Israel Deaconess Medical Center

Tracking Information
First Submitted Date  ICMJE April 5, 2016
First Posted Date  ICMJE April 15, 2016
Last Update Posted Date January 16, 2019
Study Start Date  ICMJE November 2016
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2016)
Regulatory T-Cell Count [ Time Frame: 12 weeks ]
Peripheral Blood Mononuclear Cell Flow Cytometry
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02739412 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2016)
  • Differential Immune Cell Count [ Time Frame: 12 Weeks ]
    Peripheral Blood Mononuclear Cell Flow Cytometry
  • T-Cell Exhaustion Phenotyping [ Time Frame: 1 Day ]
    Peripheral Blood Mononuclear Cell Flow Cytometry
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 14, 2019)
  • Kidney Function Serum Panel (> 1.5 x Upper Limit Normal) [ Time Frame: 12 weeks ]
    eGFR, creatinine, pH, electrolytes
  • Liver Function Serum Panel (> 2 x Upper Limit Normal) [ Time Frame: 12 weeks ]
    ALT, AST, AlkPhos, total Bilirubin
  • Serious Adverse Events (SAEs) [ Time Frame: 12 weeks ]
    Simple absolute counts and frequency
Original Other Pre-specified Outcome Measures
 (submitted: April 11, 2016)
  • Kidney Function Serum Panel (> 1.5 x Upper Limit Normal) [ Time Frame: 12 weeks ]
    eGFR, creatinine, pH, electrolytes
  • Liver Function Serum Panel (> 2 x Upper Limit Normal) [ Time Frame: 12 weeks ]
    ALT, AST, AlkPhos, total Bilirubin
  • Count and Frequency of Serious Adverse Events (SAEs) [ Time Frame: 12 weeks ]
 
Descriptive Information
Brief Title  ICMJE Efficacy of Low Dose, SubQ Interleukin-2 (IL-2) to Expand Endogenous Regulatory T-Cells in Liver Transplant Recipients
Official Title  ICMJE Efficacy of Low Dose, Subcutaneous Interleukin-2 (IL-2) to Expand Endogenous Regulatory T-Cells in Liver Transplant Recipients
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Liver Transplantation
Intervention  ICMJE Biological: Interleukin-2
Subjects will self-administer low dose IL-2 as subQ injection (0.30 MIU per meter squared body surface area) for 4 weeks.
Other Names:
  • IL-2
  • Aldesleukin
  • Proleukin
Study Arms  ICMJE Experimental: Interleukin-2
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.
Intervention: Biological: Interleukin-2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 11, 2016)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Susan McDermott, RN, MPH 617-632-9841 smcderm2@bidmc.harvard.edu
Contact: Michael P Curry, MD 617.632.9700 mcurry@bidmc.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02739412
Other Study ID Numbers  ICMJE 2016P000086
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Michael Curry, Beth Israel Deaconess Medical Center
Study Sponsor  ICMJE Beth Israel Deaconess Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Terry Strom, MD Beth Israel Deaconess Medical Center
PRS Account Beth Israel Deaconess Medical Center
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP