Longitudinal Study of Genetic Causes of Intrahepatic Cholestasis (LOGIC)

(LOGIC Trial)

Recruiting at16 trial locations

Overseen by John Magee, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Arbor Research Collaborative for Health

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Lisa Henn, PhD

Principal Investigator

Arbor Research Collaborative for Health

Ed Doo, MD

Principal Investigator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Kathleen Loomes, MD

Principal Investigator

Children's Hospital of Philadelphia

John Magee, MD

Principal Investigator

University of Michigan

Averell Sherker, MD

Principal Investigator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility Criteria

Inclusion Criteria

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 themselves have alpha-1-antitrypsin deficiency of liver disease.

Both genders, all races and ethnic groups

Treatment Details

Interventions

• No Investigational New Treatment (N/A)

Who Is Running the Clinical Trial?

Arbor Research Collaborative for Health

Lead Sponsor

Trials

21

Recruited

35,500+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Executive Officer since 2007

MD, M.A.C.P.

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Medical Officer since 2007

MD, M.A.C.P.