Ursodiol-Methotrexate for Primary Biliary Cirrhosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00006168
• Date of registration: 08/08/2000
• Prospective Registration: No
• Primary sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Public title: Ursodiol-Methotrexate for Primary Biliary Cirrhosis
• Date of first enrolment: January 1994
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00006168
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- Chronic cholestatic liver disease of at least 6 months' duration.

- Serum alkaline phosphatase levels at least 1.5 times the upper limit of normal prior
to treatment with UDCA.

- Serum bilirubin less than 3.0 mg% prior to treatment with UDCA.

- Serum albumin of 3.0 gram% or greater prior to treatment with UDCA.

- Positive antimitochondrial antibody test

- Liver biopsy within the previous 6 months after at least 6 months on UDCA (available
for review, and at least 2 cm long if cirrhosis not detected) compatible with the
diagnosis of PBC.

- Ultrasound, computed tomography (CT) or cholangiography of the biliary tree which
excludes biliary obstruction.

Exclusion Criteria:

- Treatment with immunosuppressive agents including azathioprine, chlorambucil,
colchicine, corticosteroids, or d-penicillamine in the preceding 3 months; or with
cyclosporine, FK-506 or methotrexate in the preceding 6 months.

- Treatment with rifampin in the preceding 3 months.

- Serum bilirubin of 3.0 mg% or greater.

- Serum albumin less than 3.0 gm%.

- WBC 2,500 mm3; granulocytes 1,500 mm3; platelets 80,000mm3.

- Ascites, hepatic encephalopathy, variceal bleed.

- Findings by clinical, serologic and histologic evidence of liver disease of other
etiology (such as chronic hepatitis B or C, autoimmune chronic active hepatitis,
alcoholic liver disease, sclerosing cholangitis, drug-induced liver disease,
symptomatic or obstructive gallstones).

- Pregnancy, or if not pregnant and in the reproductive period, unwillingness to
utilize an adequate form of birth control.

- Age less than 20 or greater than 69 years.

- Epilepsy requiring use of dilantin.

- Malignant disease within the past 5 years (except skin cancer)

- Anti-HIV positive. Major illnesses that could limit life span.

- History of alcoholism during the previous 2 years.

- Creatinine clearance less than 60 ml per minute.

- Severe lung disease, defined as a diffusion capacity or vital capacity of less than
50 percent of predicted.

- Patients who are both asymptomatic and have Stage I histology on liver biopsy (Ludwig
classification).



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

Health Condition(s) or Problem(s) studied

Liver Cirrhosis, Biliary

Intervention(s)

Drug: Methotrexate

Secondary ID(s)

PUMPS (completed)

5 R01 DK46602

Source(s) of Monetary Support

Please refer to primary and secondary sponsors