Phase III Randomized Study of Ursodiol With Vs Without Methotrexate for Primary Biliary Cirrhosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00004784
• Date of registration: 24/02/2000
• Prospective Registration: No
• Primary sponsor: National Center for Research Resources (NCRR)
• Public title: Phase III Randomized Study of Ursodiol With Vs Without Methotrexate for Primary Biliary Cirrhosis
• Date of first enrolment: January 1994
• Target sample size: 315
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00004784
• Study type: Interventional
• Study design: Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 3

Contacts

• Name: Burton Combes
• Affiliation: University of Texas

Key inclusion & exclusion criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- The following criteria must be met prior to study entry and
ursodiol treatment: Bilirubin less than 3 mg/dL Alkaline phosphatase at least 1.5 times
normal limits Albumin at least 3 g/dL The following criteria must be met prior to
randomization to Arms I and II: Primary biliary cirrhosis (PBC), i.e.: Cholestatic liver
disease for at least 6 months prior to randomization Liver biopsy compatible with PBC
within 6 months prior to randomization No biliary obstruction on ultrasound, computerized
tomography, or cholangiography The following exclude: Asymptomatic and stage I liver
histology (Ludwig classification) Hepatic encephalopathy Ascites Variceal bleeding No
liver disease of other etiology, e.g.: Chronic hepatitis B or C Autoimmune chronic active
hepatitis Alcoholic liver disease Sclerosing cholangitis Drug-induced liver disease
Symptomatic or obstructive gallstones --Prior/Concurrent Therapy-- At least 6 months since
the following immunosuppressives: Cyclosporine Tacrolimus Methotrexate At least 3 months
since other immunosuppressives, e.g.: Azathioprine Chlorambucil Colchicine Corticosteroids
Penicillamine At least 3 months since rifampin --Patient Characteristics-- Life
expectancy: No major illness limiting life span Hematopoietic: WBC at least 2500/mm3
Absolute granulocyte count at least 1500/mm3 Platelet count at least 80,000/mm3 Hepatic:
See Disease Characteristics Renal: Creatinine clearance at least 60 mL/min Pulmonary: No
diffusion capacity or vital capacity less than 50% of predicted Other: Antimitochondrial
antibody positive HIV antibody negative No alcoholism within the past 2 years No epilepsy
requiring phenytoin No malignancy within the past 5 years other than skin cancer No
pregnant women Adequate contraception required of fertile patients



Age minimum: 20 Years
Age maximum: 69 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Liver Cirrhosis, Biliary

Intervention(s)

Drug: methotrexate

Drug: ursodiol

Secondary ID(s)

UTSMC-29205400

199/11873

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

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

University of Texas