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Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis

This study has been completed.
Sponsor:
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00004842
First received: February 24, 2000
Last updated: May 30, 2017
Last verified: May 2017
  Purpose

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.


Condition Intervention Phase
Cholangitis, Sclerosing Liver Cirrhosis, Biliary Drug: budesonide Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Change in serum alkaline phosphatase [ Time Frame: 1 year ]

Enrollment: 22
Actual Study Start Date: May 1997
Study Completion Date: April 1999
Primary Completion Date: April 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Budesonide
Oral budesonide
Drug: budesonide
Oral budesonide, 9 mg daily was administered for 1 year

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Pathologically confirmed primary sclerosing cholangitis (PSC) meeting the following criteria:

  • Chronic cholestatic disease for at least 6 months
  • Liver biopsy within the past 6 months compatible with the diagnosis of PSC Intra and/or extrahepatic biliary duct obstruction, beading, or narrowing

OR

Pathologically confirmed primary biliary cirrhosis (PBC) that is experiencing suboptimal response to ursodeoxycholic acid and meeting the following criteria:

  • Chronic cholestatic liver disease for at least 6 months
  • Positive antimitochondrial antibody
  • No biliary obstruction by ultrasound, CT, or cholangiography
  • Prior liver biopsy compatible with diagnosis of PBC
  • Received ursodeoxycholic acid for at least 6 months

--Prior/Concurrent Therapy--

Biologic therapy:

  • At least 3 months since prior D-penicillamine
  • No planned transplantation for at least 1 year

Chemotherapy:

  • At least 3 months (6 months for PBC) since prior cyclosporin, colchicine, azathioprine, or methotrexate
  • At least 6 months since prior chlorambucil (PBC only)

Endocrine therapy: At least 3 months (6 months for PBC) since prior corticosteroids

Surgery: No prior intraductal stones or operations on the biliary tree except cholecystectomy (PSC only)

Other:

  • At least 3 months since prior pentoxifylline, ursodeoxycholic acid, or nicotine (PSC only)
  • At least 6 months since prior chenodeoxycholic acid (PBC only)

--Patient Characteristics--

Life expectancy: At least 3 years

Hematopoietic: Not specified

Hepatic:

  • Alkaline phosphatase at least 2 times upper limits of normal
  • No chronic hepatitis B infection
  • No hepatitis C infection
  • No autoimmune hepatitis
  • Bilirubin no greater than 4 mg/dL (PBC only)

Cardiovascular: No severe cardiopulmonary disease

Other:

  • No concurrent advanced malignancy
  • At least 3 months since prior inflammatory bowel disease requiring specific treatment except maintenance therapy (PSC only)
  • No anticipated need for transplantation within 1 year
  • Not pregnant
  • No liver disease of other etiology such as:

Chronic alcoholic liver disease

Hemochromatosis

Wilson's disease

Congenital biliary disease

Cholangiocarcinoma

No recurrent ascending cholangitis requiring hospitalization more than 2 times per year (PSC only)

At least 1 year since prior active peptic ulcer

No recurrent variceal bleeds

No spontaneous encephalopathy

No diuretic-resistant ascites

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004842

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Mayo Clinic
Investigators
Study Chair: Keith D. Lindor Mayo Clinic
  More Information

Publications:
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00004842     History of Changes
Other Study ID Numbers: 199/13922
MAYOC-41296 ( Other Identifier: Mayo Clinic )
R03DK052344 ( U.S. NIH Grant/Contract )
Study First Received: February 24, 2000
Last Updated: May 30, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
cirrhosis
gastrointestinal disorders
primary biliary cirrhosis
primary sclerosing cholangitis
rare disease

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Cholangitis
Cholangitis, Sclerosing
Liver Cirrhosis, Biliary
Pathologic Processes
Liver Diseases
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases
Cholestasis, Intrahepatic
Cholestasis
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 17, 2017