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:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT00490620
Eligibility Criteria:
Inclusion Criteria:
* Patients 18 years old of either sex will be recruited for this study.
* Persistently elevated alkaline phosphatase or serum aminotransferases of at least 1.5 times normal after a minimum of 6 months UDCA therapy.
* Positive serum AMA (titer \> 1:20).
* Liver biopsy histology compatible with PBC obtained at any time prior to study.
* Maintained on UDCA at a dose of 13-15 mg/kg for 6 or more months.
* Patients must read and sign informed consent form.
Exclusion Criteria:
* Patients treated with immunosuppressive or anti-inflammatory agents such as colchicine, methotrexate, D-penicillamine, cyclosporine, tacrolimus, mycophenolate mofetil, corticosteroid therapy will be excluded but may enter the study after a 3 month period off immunosuppressive and anti-inflammatory therapy.
* Advanced liver disease: Childs Pugh class B or C cirrhosis, recurrent variceal hemorrhage, spontaneous encephalopathy, diuretic resistant ascites, need for liver transplantation within the year.
* Patients with a secondary hepatic diagnosis such as viral hepatitis, drug induced liver injury, extrahepatic biliary obstruction, primary sclerosing cholangitis, metabolic liver diseases or alcoholic liver disease.
* Regular use of more than 30 g of alcohol per day in the last year.
* Patients with a predicted survival of less than 3 years from malignant or other potentially life threatening disease.
* Creatinine clearance less than \< 70 mL/min using the Cockcroft Gault equation:
* Clinically apparent pancreatitis.
* Serum amylase \> 3 x upper limit of normal (patients with sicca syndrome and salivary gland disease may have elevated amylase levels)
* Pregnancy or breast-feeding a child.
* Sexually active patients of child bearing age and not using effective contraception.
* Allergic reaction to Combivir like drugs
* Clinical evidence of myositis
* Weight of \< 50 Kg
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00490620
Study Brief:
Protocol Section:
NCT00490620