Ursodiol-Methotrexate for Primary Biliary Cirrhosis

Completed · Phase 3

Conditions studied: Liver Cirrhosis, Biliary

In brief

The major thrust is to determine whether treatment of patients with Primary Biliary Cirrhosis (PBC) with Ursodiol (Ursodeoxycholic Acid-UDCA) plus methotrexate (MTX) is more effective than treatment with UDCA alone.

Key facts

Study ID

NCT00006168

Run by

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

Starts

1994-01-01

Expected to finish

2004-03-01

Last updated by the study team

2010-01-13

Who can join

Age: 20 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Keck School of Medicine at U.S.C. — Los Angeles, California, United States
• U California Medical Center — San Francisco, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Saint Louis University — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• Albert Einstein Medical Center — Philadelphia, Pennsylvania, United States
• UT Southwestern Medical Center at Dallas — Dallas, Texas, United States
• Medical College of Virginia — Richmond, Virginia, United States
• University of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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