Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2025-12-24 @ 5:50 PM
NCT ID:
NCT00006168
Eligibility 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
69 Years
Study:
NCT00006168
Study Brief:
Protocol Section:
NCT00006168