Longitudinal Study of Genetic Causes of Intrahepatic Cholestasis (LOGIC)

Status: Suspended
Location: See all (17) locations...
Study Type: Observational
SUMMARY

Cholestasis is a condition in which bile is not properly transported from the liver to the small intestine. Cholestasis can be caused by an array of childhood diseases, including the genetic diseases Alagille syndrome (ALGS), alpha-1 antitrypsin (a-1AT) deficiency, bile acid synthesis and metabolism defects, and progressive familial intrahepatic cholestasis (PFIC) or benign recurrent intrahepatic cholestasis(BRIC). This study will investigate the natural history and progression of the four previously mentioned cholestatic liver diseases to provide a better understanding of the causes and effects of the diseases.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 25
Healthy Volunteers: f
View:

• Children and young adults diagnosed with one of the four cholestatic diseases from birth through 25 years old.

• Siblings of participants with alpha-1-antitrypsin deficiency, who are affected with alpha-1-antitrypsin deficiency, but have no evidence of liver disease.

• Both sexes, all races and ethnic groups.

• Participant meets the enrollment criteria for one of the four cholestatic liver diseases.

• Patient and/or parent/legal guardian have the ability to provide written informed consent for enrollment.

Locations
United States
California
Children's Hospital of Los Angeles
Los Angeles
University of California at San Francisco (UCSF)
San Francisco
Colorado
Children's Hospital Colorado
Aurora
Georgia
Children's Healthcare of Atlanta - Emory University
Atlanta
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago
Indiana
Riley Hospital for Children
Indianapolis
Maryland
Johns Hopkins University Hospital
Baltimore
Missouri
St. Louis University - Cardinal Glennon Children's Medical Center
St Louis
Washington University School of Medicine/St. Louis Children's Hospital
St Louis
New York
Mount Sinai School of Medicine
New York
Ohio
Cincinnati's Children's Memorial Hospital
Cincinnati
Pennsylvania
Children's Hospital of Philadelphia
Philadelphia
UPMC Children's Hospital of Pittsburgh
Pittsburgh
Texas
Baylor School of Medicine
Houston
Utah
University of Utah
Salt Lake City
Washington
Seattle Children's Hospital
Seattle
Other Locations
Canada
The Hospital for Sick Children
Toronto
Time Frame
Start Date: 2007-11-30
Completion Date: 2029-05-31
Participants
Target number of participants: 1675
Treatments
1
Infants less than 6 months old with a cholestatic liver disease who were initially enrolled into the Childhood Liver Disease Research and Education Network (ChiLDREN) Prospective Biliary Atresia Epidemiology study (PROBE study; P003)
2
Participants with a cholestatic liver disease who are between birth and 25 years old who were NOT initially enrolled into the Childhood Liver Disease Research and Education Network (ChiLDREN) Prospective Biliary Atresia Epidemiology study (PROBE study; P003)
3
Post-liver transplant participants with a cholestatic liver disease who are between 1 day and 25 years old. Affected parents of patients enrolled in the study are eligible for enrollment if they are 25 years old or less
5
Affected siblings (without evidence of liver disease) of Alpha-1 Antitrypsin Deficiency participants who are enrolled in LOGIC.
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Arbor Research Collaborative for Health

This content was sourced from clinicaltrials.gov