Biliary Atresia Study in Infants and Children



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:Any
Updated:2/21/2018
Start Date:May 2006
End Date:May 2019
Contact:Peg Hill-Callahan, BS, LSW
Email:peg.hill-callahan@arborresearch.org
Phone:734-369-9674

Use our guide to learn which trials are right for you!

Biliary Atresia Study in Infants and Children (BASIC)

Little is known about the factors that cause biliary atresia nor the factors that influence
disease progression. The purpose of this study is to collect the pertinent clinical
information, genetic material and body fluid samples to enable investigators to address the
following aims: To identify the gene or genes implicated in the etiology of BA; To identify
polymorphisms that may be important in disease progression such as HLA polymorphisms; To
characterize the natural history of the older, non-transplanted child with BA.

Little is known about the factors that cause biliary atresia nor the factors that influence
disease progression. A variety of genetic, autoimmune and environmental influences have been
hypothesized to be important. Most studies to date have focused on the neonate and young
child with BA, yet the older surviving child with BA can provide important information about
genetics, as well as, natural history.

The purpose of this study is to collect the pertinent clinical information, genetic material
and body fluid samples to enable investigators to address the following hypotheses:

Hypothesis 1: A genetic defect is a likely causative factor for BA among children with BA and
multiple congenital anomalies.

Hypothesis 2: Autoimmune factors are likely to contribute to disease progression or
acquisition and can be identified by correlating HLA among children with BA to healthy
controls and by comparison of those who develop early complications including, variceal
bleed, ascites, and growth failure compared to those who do not.

Hypothesis 3a: Sentinel events such as variceal bleeding, ascites and growth failure are
earlier predictors of death or need for liver transplantation than the pediatric end-stage
liver disease score (PELD) Hypothesis 3b: Health related quality of life will be impaired
compared to healthy age matched children and relate to severity of illness.

Hypothesis 3c: Growth failure as measured by anthropometrics and nutritional supplementation
will be predictive of onset of sentinel events (ascites, variceal bleed, death, and
transplant) in the following 24 months.

This study will be performed by the Biliary Atresia Research Clinical Research Consortium
(BARC), an NIDDK-funded network.

Inclusion Criteria:

1. Subjects need to have a confirmed diagnosis of BA determined by chart review including
review of pertinent diagnostic biopsy reports, radiologic reports and surgical reports
(if surgery was performed).

2. Subjects need to be greater than or equal to (with no upper age limit).

3. Subject either have their native liver or have a confirmed liver transplantation.

4. Parent, guardian or subject (if 18 years of age or older) is willing to provide
informed consent and, when appropriate, the subject is willing to assent.

Exclusion Criteria:

1. Enrollment in the PROBE study

2. Inability to confirm original diagnostic evaluation of biliary atresia

3. Inability or unwillingness of family or subject to participate in all scheduled
visits.
We found this trial at
16
sites
4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Principal Investigator: Kasper Wang, MD
Phone: 323-361-4566
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
?
mi
from
New York, NY
Click here to add this to my saved trials
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Kathy Loomes, MD
Phone: 215-590-2525
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Phone: 801-585-9495
University of Utah Research is a major component in the life of the U benefiting...
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Principal Investigator: Saul Karpen, MD PhD
Phone: 404-785-1467
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Phone: 720-777-4690
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Baltimore, Maryland 21287
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Principal Investigator: Estella Alonso, MD
Phone: 312-227-3523
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45229
Principal Investigator: Jorge Bezerra, MD
Phone: 513-636-7818
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Houston, Texas 77030
Phone: 832-822-3634
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46202
Principal Investigator: Jean Molleston, MD
Phone: 317-944-9605
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
3414 Fifth Avenue
Pittsburgh, Pennsylvania 15213
Principal Investigator: Robert Squires, MD
Phone: 412-692-7703
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Seattle, Washington 98105
Principal Investigator: Karen Murray, MD
Phone: 206-987-1037
?
mi
from
Seattle, WA
Click here to add this to my saved trials
555 University Avenue
Toronto, Ontario M5G 1X8
Phone: 416-813-7654
?
mi
from
Toronto,
Click here to add this to my saved trials