Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis - Tabular View

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Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis

This study is ongoing, but not recruiting participants.

Study NCT00004842. Last updated on June 23, 2005. Information provided by Office of Rare Diseases (ORD)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis

Official Title ^†

Brief 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.

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.

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Safety/Efficacy Study

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Cholangitis, Sclerosing
Liver Cirrhosis, Biliary

Intervention ^†

Drug: budesonide

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Start Date ^†

October 1998

Completion Date

Eligibility 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

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Administrative Information Fields

NCT ID ^†

NCT00004842

Organization ID

199/13922

Secondary IDs ^††

MAYOC-41296, MAYOC-DK52344

Study Sponsor ^†

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborators ^††

Mayo Clinic

Investigators ^†

Study Chair:

Keith D. Lindor

Mayo Clinic

Information Provided By

Office of Rare Diseases (ORD)

Verification Date

December 1998

First Received Date ^†

February 24, 2000

Last Updated Date

June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.