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Home > "S" Clinical Trials Conditions > Study of Oral Cholic Acid in Patients With Inborn Errors of Bile Acid Synthesis  Study of Oral Cholic Acid in Patients With Inborn Errors of Bile Acid Synthesis
Study of Oral Cholic Acid in Patients With Inborn Errors of Bile Acid Synthesis
For Condition: Hyperpipecolic Acidemia,Peroxisomal Disorders,Cholestasis,Infantile Refsum's Disease,Bifunctional Enzyme Deficiency,Zellweger Syndrome,Adrenoleukodystrophy
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , Children's Hospital Medical Center - Cincinnati
Synopsis: OBJECTIVES: I. Extend the screening procedures for the identification of patients with inborn errors in bile acid synthesis. II. Determine the pathophysiology of newly described genetic defects in these patients. III. Determine the effect of oral cholic acid on the clinical course of these patients.
Details: PROTOCOL OUTLINE: Patients receive oral cholic acid and oral chenodeoxycholic acid on Day 1. Bile is collected on Day 2, followed by a percutaneous liver biopsy on Day 3. Patients then receive oral cholic acid beginning on Day 4 and continuing indefinitely.
Eligibility:
Study Type: Observational, Screening
Minimum Age/Maximum Age: /17 Years
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Clinical or biochemical evidence of liver disease, unexplained fat-soluble vitamin malabsorption, or peroxisomal dysfunction that compromises bile acid biosynthesis: Zellweger syndrome, Infantile Refsum's disease, Pseudo-Zellweger syndrome, Neonatal adrenoleukodystrophy, Hyperpipecolic acidemia, or Bifunctional enzyme deficiency Presenting for evaluation of cholestasis: bilirubin greater than 2 mg/dL OR increased serum bile acids for age Other organ dysfunction allowed
Total Enrollment: 21
Location and Contact Information:
Overall Study Official:
JamesHeubi, Study Chair, Children's Hospital Medical Center - Cincinnati
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039
United States
Additional Information:
Study ID Numbers: NCRR-M01RR08084-0009; CHMC-C-91-10-10
Study Start Date: August 2000
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00007020
Other Bifunctional Enzyme Deficiency Studies:
1. Study of Protein Translocation in Patients With Beta-Oxidation Disorders
2. Study of Oral Cholic Acid in Patients With Inborn Errors of Bile Acid Synthesis
3. Phase II Study of Allogeneic Bone Marrow or Umbilical Cord Blood Transplantation in Patients With Lysosomal or Peroxisomal Inborn Errors of Metabolism
Related Studies:
Other Bifunctional Enzyme Deficiency Clinical Trials
Other Ohio Clinical Trials
Other Cincinnati Clinical Trials
Study of Oral Cholic Acid in Patients With Inborn Errors of Bile Acid Synthesis
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