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Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis
This study is ongoing, but not recruiting participants.
Study NCT00004842   Information provided by Office of Rare Diseases (ORD)
First Received: February 24, 2000   Last Updated: June 23, 2005   History of Changes

February 24, 2000
June 23, 2005
October 1998
 
 
 
Complete list of historical versions of study NCT00004842 on ClinicalTrials.gov Archive Site
 
 
 
Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis
 

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.

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.

Phase I
Interventional
Treatment, Safety/Efficacy Study
  • Cholangitis, Sclerosing
  • Liver Cirrhosis, Biliary
Drug: budesonide
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
50
 
 

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

Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00004842
 
199/13922, MAYOC-41296, MAYOC-DK52344
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Mayo Clinic
Study Chair: Keith D. Lindor Mayo Clinic
Office of Rare Diseases (ORD)
December 1998

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP