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Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 1998 by Office of Rare Diseases (ORD).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Mayo Clinic
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004842
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: December 1998
  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: Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 50
Study Start Date: October 1998
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
Genders Eligible for Study:   Both
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

Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Keith D. Lindor Mayo Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004842     History of Changes
Other Study ID Numbers: 199/13922, MAYOC-41296, MAYOC-DK52344
Study First Received: February 24, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
cirrhosis
gastrointestinal disorders
primary biliary cirrhosis
primary sclerosing cholangitis
rare disease

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

ClinicalTrials.gov processed this record on November 20, 2014