Ursodiol-Methotrexate for Primary Biliary Cirrhosis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00006168 |
Recruitment Status :
Completed
First Posted : August 9, 2000
Last Update Posted : January 13, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Liver Cirrhosis, Biliary | Drug: Methotrexate | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Allocation: | Randomized |
Masking: | Double |
Primary Purpose: | Treatment |
Study Start Date : | January 1994 |
Study Completion Date : | March 2004 |


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Ages Eligible for Study: | 20 Years to 69 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006168
United States, California | |
Keck School of Medicine at U.S.C. | |
Los Angeles, California, United States, 90033 | |
U California Medical Center | |
San Francisco, California, United States, 94143 | |
United States, Connecticut | |
Yale University School of Medicine | |
New Haven, Connecticut, United States, 06520-8019 | |
United States, Georgia | |
Emory University School of Medicine | |
Atlanta, Georgia, United States, 30322 | |
United States, Missouri | |
Saint Louis University | |
St. Louis, Missouri, United States, 63104 | |
United States, Nebraska | |
University of Nebraska Medical Center | |
Omaha, Nebraska, United States, 68198-3285 | |
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 | |
United States, Oregon | |
Oregon Health Sciences University | |
Portland, Oregon, United States, 97201 | |
United States, Pennsylvania | |
Albert Einstein Medical Center | |
Philadelphia, Pennsylvania, United States, 19141 | |
United States, Texas | |
UT Southwestern Medical Center at Dallas | |
Dallas, Texas, United States, 75235-9151 | |
United States, Virginia | |
Medical College of Virginia | |
Richmond, Virginia, United States, 23298-0711 | |
United States, Washington | |
University of Washington Medical Center | |
Seattle, Washington, United States, 98195 |
ClinicalTrials.gov Identifier: | NCT00006168 |
Other Study ID Numbers: |
PUMPS (completed) 5R01DK046602 ( U.S. NIH Grant/Contract ) |
First Posted: | August 9, 2000 Key Record Dates |
Last Update Posted: | January 13, 2010 |
Last Verified: | January 2010 |
primary biliary cirrhosis Ursodeoxycholic acid UDCA MTX |
Hepatology methotrexate liver |
Liver Cirrhosis Liver Cirrhosis, Biliary Fibrosis Pathologic Processes Liver Diseases Digestive System Diseases Cholestasis, Intrahepatic Cholestasis Bile Duct Diseases Biliary Tract Diseases Methotrexate Abortifacient Agents, Nonsteroidal Abortifacient Agents |
Reproductive Control Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |