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Phase 2
18 Years
Open (Enrolling)
Transplantation, Liver

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Trial Information

Inclusion Criteria:

- Subject and/or parent guardian must be able to understand and provide informed

- Is the recipient of a living or deceased donor liver tx when subject was less than or
equal to 6 years of age;

- Is at least 4 years post-tx at the time of study enrollment;

- Has normal allograft function defined as Alanine aminotransferase (ALT) < 50 IU/l and
gamma-glutamyl transferase (GGT) < 50 IU/l;

- Has no evidence of AR or CR within the past 2 years, based on medical history;

- Is stable on IS monotherapy with a calcineurin inhibitor (CNI);

- For female subjects of childbearing potential, subject must have a negative pregnancy
test upon study entry;

- For female and male subjects with reproductive potential, subject must agree to use
FDA approved methods of birth control for the duration of the study;

- Must be negative for HBV and HCV infection within one year of enrollment;

- Must have screening biopsy that fulfills, based on central pathology reading,

Exclusion Criteria:

- Have received a liver tx for autoimmune liver disease, including autoimmune hepatitis
or primary sclerosing cholangitis;

- Have received a liver tx for hepatitis B or hepatitis C;

- Have received a second organ transplant before, simultaneously, or after liver tx;

- Have a calculated GFR (modified Schwartz formula) of less than 60 mL/min/1.73 m2;

- Have had a 50% dose increase in CNI within 6 months of screening;

- Have discontinued a second IS agent within 12 months of screening;

- Have any systemic illness requiring or likely to require chronic or recurrent use of

- Is pregnant or breastfeeding;

- Is unwilling or unable to adhere with study requirements and procedures;

- Have mental illness or history of drug or alcohol abuse that, in the opinion of the
investigator, would interfere with the participant's ability to comply with study

- Is unwilling or unable to provide consent or comply with the study protocol;

- Has used investigational drugs within 4 weeks of enrollment;

- Is receiving treatment for HIV infection;

- Has received any licensed or investigational live attenuated vaccine(s) within two
months of enrollment;

- Has any medical condition that, in the opinion of the investigator, will interfere
with safe participation in the trial.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of subjects with normal liver biopsy and test results

Outcome Description:

The proportion of participants that is operationally tolerant, defined as those who successfully withdraw from IS and maintain normal allograft status as assessed by liver biopsy and liver tests 12 months after complete ISW.

Outcome Time Frame:

12 months post-IS withdrawal

Safety Issue:


Principal Investigator

S Feng, M.D. , Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco


United States: Federal Government

Study ID:




Start Date:

August 2012

Completion Date:

July 2017

Related Keywords:

  • Transplantation, Liver
  • liver
  • transplant
  • immunosuppression withdrawal



Children's Hospital of Philadelphia Philadelphia, Pennsylvania  19104
Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania  15213
Texas Children's Hospital Houston, Texas  
University of California San Francisco, California  94108
Cincinnati Children's Hospital Cincinnati, Ohio  45229
Children's Hospital of Colorado Aurora, Colorado  80045
Emory University and Children's Hospital of Atlanta Atlanta, Georgia  30322
St. Louis Children's Hospital - Washington University St. Louis, Missouri  63110
New York Presbyterian Morgan Stanley Children's Hospital - Columbia University Medical Center New York, New York  10032
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois  60614
University of Michigan C. S. Mott Children's Hospital Ann Arbor, Michigan  94143