TRIALS GOING ON NOW; Oral Budesonide in the Treatment of Patients With Primary Biliary Cirrhosis and Overlap Features of Autoimmune Hepatitis

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Oral Budesonide in the Treatment of Patients With Primary Biliary Cirrhosis and

Overlap Features of Autoimmune Hepatitis (PBC)

This study is currently recruiting participants.

Verified by Mayo Clinic, October 2008

Sponsored by: Mayo Clinic

Information provided by: Mayo Clinic

ClinicalTrials.gov Identifier: NCT00587119

Purpose

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.

Condition Intervention

Primary Biliary Cirrhosis

Autoimmune Hepatitis

Drug: Budesonide

MedlinePlus related topics: Cirrhosis Hepatitis

Drug Information available for: Budesonide Ursodeoxycholic acid

U.S. FDA Resources

Study Type:Interventional

Study Design:Treatment, Open Label, Active Control, Single Group Assignment,

Safety/Efficacy Study

Official Title:Open-Label Pilot Study Evaluating Oral Budesonide in the

Treatment of Patients With Primary Biliary Cirrhosis and Overlap Features of

Autoimmune Hepatitis.

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

a.. 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.

[ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

a.. 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.

[ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:30

Study Start Date:December 2007

Estimated Study Completion Date:January 2010

Estimated Primary Completion Date:January 2010 (Final data collection date for

primary outcome measure)

Arms Assigned Interventions

1: Experimental

Single arm, active treatment Drug: Budesonide

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

Detailed Description:

Pilot Study of Budesonide for Primary Biliary Cirrhosis with overlap features of

Autoimmune Hepatitis Primary biliary cirrhosis (PBC) is a chronic liver disease

of unknown cause that may result in inflammation and destruction of the bile

ducts inside the liver. Over time, cirrhosis and complications of liver failure

may develop. Although treatment with ursodiol has been association with a

reduction in liver enzymes (blood tests) and a reduction in the progression of

the disease, some patients do not respond to ursodiol therapy. Patients with

overlap features of Autoimmune Hepatitis (AIH) appear to be at higher risk of

developing complications of disease even when on ursodiol. The purpose of this

study is to evaluate the effects and safety of Budesonide in PBC with overlap

features of AIH. Budesonide has unique effects on the immune system that may be

helpful in the treatment of the disease.

Eligible participants will include those patients with a diagnosis of PBC with

overlap features of AIH and in whom liver enzymes have not sufficiently improved

with ursodiol therapy (the alkaline phosphatase is not less than twice upper

normal). At entry all patients will have a history and physical examination,

blood tests, bone densitometry and complete quality of life questionnaires.

Patients will be prescribed Budesonide 9 mg to take daily for one year in

addition to the ursodiol. The medication can be taken with or without food.

Blood tests and symptoms diaries will be completed every 3 months. Patients will

be contacted by phone to assess tolerance of the medication and any new health

problems. At one year, patients will return for a history and physical and

repeat blood tests and bone densitometry. Possible side-effects include bone

mass loss (bone thinning), diarrhea, indigestion, nausea, joint pains,

dizziness, headaches, weight gain and Cushing's syndrome. Other side-effects are

possible. The medication and the tests will be billed to the patient or

patient's insurance.

Eligibility

Ages Eligible for Study:21 Years to 75 Years

Genders Eligible for Study:Both

Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:

a.. Chronic cholestatic liver disease for greater than 6 months with alkaline

phosphatase levels greater than 2 times the upper limit of normal.

b.. Positive AMA titer 1:40 or AMA > 1.0 U.

c.. Liver histology in the past (available for review) with features

consistent with or diagnostic of PBC

d.. Ultrasound, computed tomography (CT), or cholangiography of the biliary

tree which excludes biliary obstruction.

e.. 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.

Exclusion Criteria:

a.. 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.

b.. Patients unable to provide informed consent.

c.. Treatment with methotrexate, corticosteroids, azathioprine, chlorambucil,

cyclosporin, penicillamine, colchicine or chenodeoxycholic acid in the preceding

three months.

d.. Anticipated need for transplantation in one year (Mayo survival model <80%

one-year survival without transplant).

e.. Liver biopsy revealing stage IV disease.

f.. Evidence of portal hypertension such as esophageal varices, portal

gastropathy, ascites or hepatic encephalopathy.

g.. Known history of portal vein thrombosis.

h.. Evidence of osteoporosis.

i.. Serum bilirubin >4 mg/dl.

j.. Age less than 21 years of age or greater than 75 years of age.

k.. Pregnancy.

l.. Breast-feeding.

m.. Active drug or alcohol use.

n.. Findings highly suggestive of liver disease of other etiology such as

chronic alcoholic liver disease, chronic hepatitis B or C infection,

hemochromatosis, 's disease, 1-antitrypsin deficiency, non-alcoholic

steatohepatitis or sclerosing cholangitis.

o.. Serum creatinine over 2.0 mg/dl.

p.. History of documented active peptic ulcer disease in preceding year.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587119

Contacts

Contact: D Lindor, MD 507-284-2969 lindor.keith@...

Locations

United States, Minnesota

Mayo Clinic Recruiting

Rochester, Minnesota, United States, 55905

Contact: Jan L Petz, RN 507-284-1738 jpetz@...

Contact: a A nsen, MS, RN 507-284-2698

jorensen.roberta@...

Principal Investigator: D Lindor, MD

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: D Lindor, MD Mayo Clinic

More Information

Mayo Clinic Clinical Trials

Responsible Party:Mayo Clinic Rochester ( Dr. D. Lindor / PI )

Study ID Numbers:07-003586, Budesonide

First Received:December 21, 2007

Last Updated:October 27, 2008

ClinicalTrials.gov Identifier:NCT00587119 [history]

Health Authority:United States: Institutional Review Board

Keywords provided by Mayo Clinic:

Urso

Budesonide

PBC

overlap AIH

PBC with overlap features of autoimmune hepatitis

Study placed in the following topic categories:

Biliary cirrhosis

Liver Diseases

Autoimmune Diseases

Hepatitis, Chronic

Fibrosis

Cholestasis

Budesonide

Liver Cirrhosis

Autoimmune hepatitis

Hepatitis, Autoimmune

Ursodeoxycholic Acid

Hepatitis

Cholestasis, Intrahepatic

Digestive System Diseases

Bile Duct Diseases

Biliary Tract Diseases

Primary biliary cirrhosis

Liver Cirrhosis, Biliary

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Respiratory System Agents

Immune System Diseases

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Anti-Asthmatic Agents

Glucocorticoids

Hormones

Pharmacologic Actions

Pathologic Processes

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Bronchodilator Agents

ClinicalTrials.gov processed this record on January 02, 2009

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