NCT00571272|SuspendedDMC
Longitudinal Study of Genetic Causes of Intrahepatic Cholestasis (LOGIC)
LOGIC
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LOGIC
Sponsor study identifier
Secondary identifiers
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
observational
1,675
2 countries
17
Study Start
November 30, 2007
Actual (reported)Primary Completion
May 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 30, 2007
Actual (reported)December 7, 2007
Actual (reported)December 11, 2007
Actual (reported)May 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Demonstration of disease progression for each of the four cholestatic liver diseases of the study, including liver transplantation, death, growth failure, worsening liver function, and developmental complications of portal high blood pressure
Measured at baseline and annually through year 10
Jaundice (total serum bilirubin of greater than 2.0 mg/dl)
Measured at baseline and annually through year 10
Listing for liver transplantation
Measured at baseline and annually through year 10
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)
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)
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
Affected siblings (without evidence of liver disease) of Alpha-1 Antitrypsin Deficiency participants who are enrolled in LOGIC.
The study population will consist of 400 participants with Alagille syndrome, 400 with alpha-1 trypsin deficieny (of which up to 25 may be siblings of participants), 300 with PFIC (or BRIC), and 50 with bile acid synthesis defects.
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
University of California at San Francisco (UCSF)
San Francisco, California, 94143, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Children's Healthcare of Atlanta - Emory University
Atlanta, Georgia, 30322, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Johns Hopkins University Hospital
Teckman J, Rosenthal P, Ignacio RV, Spino C, Bass LM, Horslen S, Wang K, Magee JC, Karpen S, Asai A, Molleston JP, Squires RH, Kamath BM, Guthery SL, Loomes KM, Shneider BL, Sokol RJ; ChiLDReN (Childhood Liver Disease Research Network). Neonatal cholestasis in children with Alpha-1-AT deficiency is a risk for earlier severe liver disease with male predominance. Hepatol Commun. 2023 Dec 7;7(12):e0345. doi: 10.1097/HC9.0000000000000345. eCollection 2023 Dec 1.
Leung DH, Sorensen LG, Ye W, Hawthorne K, Ng VL, Loomes KM, Fredericks EM, Alonso EM, Heubi JE, Horslen SP, Karpen SJ, Molleston JP, Rosenthal P, Sokol RJ, Squires RH, Wang KS, Kamath BM, Magee JC; Childhood Liver Disease Research Network (ChiLDReN). Neurodevelopmental Outcomes in Children With Inherited Liver Disease and Native Liver. J Pediatr Gastroenterol Nutr. 2022 Jan 1;74(1):96-103. doi: 10.1097/MPG.0000000000003337.
Kathleen Loomes, MD
Children's Hospital of Philadelphia
Ed Doo, MD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
John Magee, MD
University of Michigan
Lisa Henn, PhD
Arbor Research Collaborative for Health
First Submitted
December 7, 2007
First Posted
December 11, 2007
Study Start
November 30, 2007
Actual (reported)Primary Completion
May 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
YSPSL for Prevention of Delayed Graft Function in Cadaveric Liver Transplantation
Calculated Pediatric End-Stage Liver Disease (PELD) score for participants less than 12 years of age or Model for End-Stage Liver Disease (MELD) score for participants 12 years of age or older
Measured at baseline and annually through year 10
Health related quality of life
Measured at baseline and annually through year 10
Growth (length and weight Z-score)
Measured at baseline and annually through year 10
Contact the study team to confirm eligibility.
Baltimore, Maryland, 21287, United States
St. Louis University - Cardinal Glennon Children's Medical Center
St Louis, Missouri, 63104, United States
Washington University School of Medicine/St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Cincinnati's Children's Memorial Hospital
Cincinnati, Ohio, 60190, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Baylor School of Medicine
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84113, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Teckman JH, Rosenthal P, Abel R, Bass LM, Michail S, Murray KF, Rudnick DA, Thomas DW, Spino C, Arnon R, Hertel PM, Heubi J, Kamath BM, Karnsakul W, Loomes KM, Magee JC, Molleston JP, Romero R, Shneider BL, Sherker AH, Sokol RJ; Childhood Liver Disease Research Network (ChiLDReN). Baseline Analysis of a Young alpha-1-Antitrypsin Deficiency Liver Disease Cohort Reveals Frequent Portal Hypertension. J Pediatr Gastroenterol Nutr. 2015 Jul;61(1):94-101. doi: 10.1097/MPG.0000000000000753.
Katrina Loh, MD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Completion
May 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 4, 2026
Record last verified: 2026-06
The data will be transferred to NIDDK at the end of the study.
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Source: ClinicalTrials.gov.
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