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Generated: February 17, 2019

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CLINICAL TRIALS PROFILE FOR URSODIOL

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Clinical Trials for Ursodiol

Trial ID Title Status Sponsor Phase Summary
NCT00004315 Phase II Pilot Study to Compare the Bioavailability of Buffered, Enteric-Coated Ursodiol With Unmodified Ursodiol for Chronic Cholestatic Liver Disease and Cystic Fibrosis-Associated Liver Disease Unknown status Children's Hospital Medical Center, Cincinnati Phase 2 OBJECTIVES: I. Compare the bioavailability of polymer-coated and buffered ursodiol (ursodeoxycholic acid) to unmodified ursodiol in patients with cystic fibrosis-associated liver disease or chronic cholestatic liver disease. II. Compare the differences in pruritus, weight gain, and liver function for both treatments.
NCT00004315 Phase II Pilot Study to Compare the Bioavailability of Buffered, Enteric-Coated Ursodiol With Unmodified Ursodiol for Chronic Cholestatic Liver Disease and Cystic Fibrosis-Associated Liver Disease Unknown status National Center for Research Resources (NCRR) Phase 2 OBJECTIVES: I. Compare the bioavailability of polymer-coated and buffered ursodiol (ursodeoxycholic acid) to unmodified ursodiol in patients with cystic fibrosis-associated liver disease or chronic cholestatic liver disease. II. Compare the differences in pruritus, weight gain, and liver function for both treatments.
NCT00004441 Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic Fibrosis Completed Children's Hospital Medical Center, Cincinnati N/A OBJECTIVES: I. Determine the optimum dose of tauroursodeoxycholic acid (TUDCA) required to achieve maximal bioavailability for patients with cystic fibrosis-associated liver disease. II. Compare optimized doses of TUDCA with ursodiol (ursodeoxycholic acid; UDCA) for effects on biliary bile acid composition and metabolism, serum biochemistries, fat absorption, and fat-soluble vitamin status in these patients.
NCT00004748 Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis Completed Tufts Medical Center Phase 3 OBJECTIVES: I. Compare the efficacy of low-dose oral pulse methotrexate (MTX) and ursodiol versus colchicine and ursodiol in patients with primary biliary cirrhosis (PBC). II. Determine the optimum dose and duration of MTX treatment. III. Investigate the role of fibrogenic cytokines (FC) in PBC pathogenesis and the effect of treatment on FC production.
NCT00004748 Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis Completed National Center for Research Resources (NCRR) Phase 3 OBJECTIVES: I. Compare the efficacy of low-dose oral pulse methotrexate (MTX) and ursodiol versus colchicine and ursodiol in patients with primary biliary cirrhosis (PBC). II. Determine the optimum dose and duration of MTX treatment. III. Investigate the role of fibrogenic cytokines (FC) in PBC pathogenesis and the effect of treatment on FC production.
NCT00004784 Phase III Randomized Study of Ursodiol With Vs Without Methotrexate for Primary Biliary Cirrhosis Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 3 OBJECTIVES: I. Compare the effects of ursodiol (ursodeoxycholic acid), with and without methotrexate, on pruritus, incapacitation index, and serum markers of activity and severity in patients with primary biliary cirrhosis. II. Compare the effects of these regimens on the development of ascites, encephalopathy, varices (or bleeding from pre-existing varices), histologic liver changes, transplantation, and survival. III. Compare the toxicity and safety of each regimen.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Ursodiol

Condition Name

Condition Name for Ursodiol
Intervention Trials
Healthy 5
Liver Cirrhosis, Biliary 4
Cholestasis 2
Primary Biliary Cirrhosis 2
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Condition MeSH

Condition MeSH for Ursodiol
Intervention Trials
Fibrosis 8
Liver Cirrhosis, Biliary 6
Liver Cirrhosis 6
Liver Diseases 2
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Clinical Trial Locations for Ursodiol

Trials by Country

Trials by Country for Ursodiol
Location Trials
United States 48
Canada 6
Italy 2
Israel 1
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Trials by US State

Trials by US State for Ursodiol
Location Trials
Texas 5
Arizona 3
Washington 3
Pennsylvania 3
California 3
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Clinical Trial Progress for Ursodiol

Clinical Trial Phase

Clinical Trial Phase for Ursodiol
Clinical Trial Phase Trials
Phase 4 1
Phase 3 5
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Ursodiol
Clinical Trial Phase Trials
Completed 17
Recruiting 4
Terminated 4
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Clinical Trial Sponsors for Ursodiol

Sponsor Name

Sponsor Name for Ursodiol
Sponsor Trials
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 5
National Cancer Institute (NCI) 4
National Center for Research Resources (NCRR) 3
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Sponsor Type

Sponsor Type for Ursodiol
Sponsor Trials
Other 39
NIH 13
Industry 8
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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Teva
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Medtronic
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AstraZeneca
Merck
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