Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT00004842 |
Date of registration:
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24/02/2000 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis
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Scientific title:
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Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis |
Date of first enrolment:
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May 1997 |
Target sample size:
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22 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT00004842 |
Study type:
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Interventional |
Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Keith D. Lindor |
Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cholangitis, Sclerosing
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Liver Cirrhosis, Biliary
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Intervention(s)
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Drug: budesonide
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Primary Outcome(s)
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Change in serum alkaline phosphatase
[Time Frame: 1 year]
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Secondary ID(s)
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MAYOC-41296
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R03DK052344
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199/13922
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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