This is a prospective multi-center, longitudinal study to determine efficacy of 50 percent Immunosuppression (IS) reduction. One hundred fully eligible participants will reduce IS by 50 percent in two steps. Liver tests will be checked every 0.5 months through month 4, once a month through month 12, and every other month through month 18. Liver transplant (LTx) center visits will take place at screening, months 6, 12 and 18 after initiating IS dose reduction. A protocol driven liver biopsy to adjudicate the endpoint will be performed at 18 months. The duration of the study from time of starting IS dose reduction to the primary endpoint assessment is 18 months. The primary objective is to assess the efficacy of 50 percent IS dose reduction in children with Liver transplants (LTxs)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Prospective multi-center, longitudinal study to determine the success rate of 50% immunosuppression (IS) dose reduction. One hundred fully eligible participants will reduce IS by 50% in two steps
UCSF Benioff Children's Hospital
San Francisco, California, United States
NOT_YET_RECRUITINGChildren's Hospital Colorado
Aurora, Colorado, United States
NOT_YET_RECRUITINGMedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
NOT_YET_RECRUITINGEmory University School of Medicine/Children's Healthcare of Atlanta
Atlanta, Georgia, United States
NOT_YET_RECRUITINGAnn and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
RECRUITINGIcahn School of Medicine at Mount Sinai
New York, New York, United States
NOT_YET_RECRUITINGColumbia University Medical Center
New York, New York, United States
NOT_YET_RECRUITINGCincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
RECRUITINGChildren's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
NOT_YET_RECRUITINGMonroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
NOT_YET_RECRUITINGAchieving successful 50 percent Immunosuppression (IS) reduction
Defined as meeting both biochemical and histological criteria of stability
Time frame: At 18 months
Clinical severity of Acute rejection (AR) episodes
Clinical severity - treatment required for resolution
Time frame: At 18 months
Histological severity of Acute rejection (AR) episodes
Time frame: At 18 months
The proportion of participants who experience Acute rejection (AR)
Defined as either biopsy-proven or clinical AR
Time frame: At 18 months
Achieving clinically successful 50 percent Immunosuppression (IS) reduction
Defined as meeting biochemical but not histological criteria of stability
Time frame: At 18 months
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