Immunosuppression Withdrawal for Stable Pediatric Liver Transplant Recipients



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any - 18
Updated:8/16/2018
Start Date:August 14, 2012
End Date:June 11, 2018

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The primary objective of this study is to assess the efficacy of immunosuppression withdrawal
(ISW) in pediatric liver transplant (tx) recipients.

Anti-rejection medicines, also known as immunosuppressive drugs, are prescribed to organ
transplant recipients to prevent rejection of the new organ. Long-term use of these medicines
places transplant recipients at higher risk of serious infections and certain types of
cancer.

This study seeks to:

- Find out if it is safe to slowly reduce and then completely stop the immunosuppression
taken by children who have received liver transplants. This process is called
'immunosuppression withdrawal'or ISW.

- Find blood or liver biopsy tests that can help transplant doctors in the future to
predict if it is safe to decrease or stop immunosuppression drugs in children who have
had a liver transplant.

Inclusion Criteria:

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

- 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 acute rejection (AR) or chronic rejection (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 hepatitis B virus (HBV) and hepatitis C virus (HCV) infection
within one year of enrollment;

- Must have screening biopsy that fulfills, based on central pathology reading, the
following criteria:

- Portal inflammation and interface activity: Preferably absent, but minimal to
focal mild portal mononuclear inflammation may be present. Interface
necro-inflammatory activity is absent or equivocal/minimal and, if present,
involves a minority of portal tracts.

- Centrizonal/peri-venular inflammation: Preferably absent, but minimal to focal
mild perivenular mononuclear inflammation may be present. Perivenular
necro-inflammatory activity is absent or equivocal/minimal and, if present,
involves a minority of terminal hepatic venules.

- Bile duct changes: No lymphocytic bile duct damage, ductopenia and biliary
epithelial senescence changes, unless there is an alternative, non-immunologic
explanation (e.g. biliary strictures).

- Fibrosis: < Ishak Stage 3 (i.e. not more than occasional portal-to-portal
bridging). Perivenular fibrosis should be less than "moderate", according to
Banff Criteria.

- Arteries: Negative for obliterative or foam cell arteriopathy.

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 glomerular filtration rate (modified Schwartz formula) of less than
60 mL/min/1.73 m^2;

- Have had a 50 percent (%) 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;

- 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
requirements;

- 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.
We found this trial at
12
sites
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Ann Arbor, MI
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Atlanta, GA
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Cincinnati, Ohio 45229
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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3414 Fifth Avenue
Pittsburgh, Pennsylvania 15213
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1 Childrens Place
Saint Louis, Missouri 63110
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San Francisco, California 94143
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555 University Avenue
Toronto, Ontario M5G 1X8
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Toronto,
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