Oral Budesonide in the Treatment of Patients With Primary Biliary Cirrhosis and Overlap Features of Autoimmune Hepatitis

NCT00587119 | Withdrawn

• 2 other identifiers: 07-003586Budesonide
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to find out the effects Budesonide, 9 mg daily for one year, has on patients with Primary Biliary Cirrhosis with features of autoimmune hepatitis.

Conditions

Primary Biliary Cirrhosis; Autoimmune Hepatitis

Keywords

Urso; Budesonide; PBC; overlap AIH; PBC with overlap features of autoimmune hepatitis

Outcome Measures

Primary Outcomes (1)

• The main endpoint will be the percentage of patients with improvement in alkaline phosphatase to less than 1.5 times normal over one year and the percentage of patients with a reduction in their Mayo Risk Score over one year.

  1 year

Secondary Outcomes (1)

• Effects of UDCA & budesonide on serum levels of alk phos, AST, total bilirubin, albumin, and prothrombin time, Mayo risk score and toxicity and tolerability of the budesonide/UDCA regimen, including effects on bone density.

  1 year

Study Arms (1)

1

EXPERIMENTAL

Single arm, active treatment

Drug: Budesonide

Interventions

Budesonide DRUG

Oral Budesonide, 3 mg three times daily, will be given for 1 year.

Also known as: Entocort

1

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic cholestatic liver disease for greater than 6 months with alkaline phosphatase levels greater than 2 times the upper limit of normal.
• Positive AMA titer 1:40 or AMA \> 1.0 U.
• Liver histology in the past (available for review) with features consistent with or diagnostic of PBC
• Ultrasound, computed tomography (CT), or cholangiography of the biliary tree which excludes biliary obstruction.
• The diagnosis of AIH necessary for evaluation of PBC-AIH overlap syndrome will be based on the revised International Autoimmune Hepatitis Group (IAHG) Scoring System.

You may not qualify if:

• Patients with other serious coexistent conditions such as pre-existing advanced malignancy or severe cardiopulmonary disease which would be expected to limit their expectancy to less than three years.
• Patients unable to provide informed consent.
• Treatment with methotrexate, corticosteroids, azathioprine, chlorambucil, cyclosporin, penicillamine, colchicine or chenodeoxycholic acid in the preceding three months.
• Anticipated need for transplantation in one year (Mayo survival model \<80% one-year survival without transplant).
• Liver biopsy revealing stage IV disease.
• Evidence of portal hypertension such as esophageal varices, portal gastropathy, ascites or hepatic encephalopathy.
• Known history of portal vein thrombosis.
• Evidence of osteoporosis.
• Serum bilirubin \>4 mg/dl.
• Age less than 21 years of age or greater than 75 years of age.
• Pregnancy.
• Breast-feeding.
• Active drug or alcohol use.
• Findings highly suggestive of liver disease of other etiology such as chronic alcoholic liver disease, chronic hepatitis B or C infection, hemochromatosis, Wilson's disease, 1-antitrypsin deficiency, non-alcoholic steatohepatitis or sclerosing cholangitis.
• Serum creatinine over 2.0 mg/dl.

Sponsors & Collaborators

• Mayo Clinic: lead

MeSH Terms

Conditions

Liver Cirrhosis, Biliary; Hepatitis, Autoimmune

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hepatitis, Chronic; Hepatitis; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Keith D Lindor, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 7, 2008
• Study Start: December 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: October 5, 2010

Record last verified: 2010-10