Clinical Trials Logo

Clinical Trial Summary

OBJECTIVES: I. Assess the safety and effectiveness of budesonide in patients with primary sclerosing cholangitis or primary biliary cirrhosis experiencing a suboptimal response to ursodeoxycholic acid.

II. Estimate the efficacy of this therapy in these patient groups as a means of evaluating the feasibility of a long-term randomized trial.


Clinical Trial Description

PROTOCOL OUTLINE:

Patients receive budesonide by mouth 3 times daily for a minimum of 6 months. If liver biochemistries become normal, dosage is reduced to once daily. Treatment discontinues after 1 year. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00004842
Study type Interventional
Source National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact
Status Completed
Phase Phase 1
Start date May 1997
Completion date April 1999

See also
  Status Clinical Trial Phase
Completed NCT02917408 - Retrospective Study About Primary Biliary Cholangitis During January 2001 to July 2016 at West China Hospital
Terminated NCT00550862 - Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC) Phase 2
Completed NCT00004748 - Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis Phase 3
Completed NCT03630718 - Trial of Psychoeducational and Hypnosis Interventions on the Fatigue Associated With PBC in Women N/A
Terminated NCT03633227 - Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment Phase 4
Terminated NCT00125281 - SAMe to Treat Biliary Cirrhosis Symptoms Phase 2
Completed NCT04629456 - Physical Therapy for Liver Cirrhosis N/A
Completed NCT03468699 - Autologous Bone Marrow Mononuclear Stem Cell for Children Suffering From Liver Cirrhosis Due to Biliary Atresia Phase 2
Completed NCT00006168 - Ursodiol-Methotrexate for Primary Biliary Cirrhosis Phase 3
Completed NCT00004784 - Phase III Randomized Study of Ursodiol With Vs Without Methotrexate for Primary Biliary Cirrhosis Phase 3
Completed NCT00570765 - Study of INT-747 as Monotherapy in Participants With Primary Biliary Cirrhosis (PBC) Phase 2
Recruiting NCT00160940 - Differential Gene Expression of Liver Tissue and Blood From Individuals With Chronic Viral Hepatitis N/A
Recruiting NCT03146910 - Swiss Primary Biliary Cholangitis Cohort Study
Terminated NCT03265249 - BRIDGE Device for Post-operative Pain Control N/A
Terminated NCT02308111 - Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis Phase 4
Recruiting NCT02936596 - Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome N/A
Completed NCT00406237 - Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis Phase 1
Completed NCT04047160 - Safety, Tolerability of OP-724 in Patients With Primary Biliary Cholangitis (Phase I) Phase 1
Recruiting NCT00145964 - Identification of the Genetic Variants Responsible for Primary Biliary Cirrhosis (PBC) N/A
Terminated NCT03476993 - Non-comparative Study of BCD-085 in Combination With UDCA in Patients With Primary Biliary Cholangitis Phase 2