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 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT01614405
Eligibility Criteria:
Inclusion Criteria:
1. Patients 18 years old of either sex will be recruited for this study.
2. Elevated ALP after 6 months UDCA therapy ≥ 2 x upper limit of normal or abnormal bilirubin.
3. Positive serum AMA or Liver biopsy histology compatible with PBC.
4. Maintained on UDCA at a dose of 13-15 mg/kg for 6 or more months.
5. Patients must read and sign informed consent form
Exclusion Criteria:
1. Subjects with baseline AST or ALT \> 5 x ULN.
2. Patients who have altered dose of any medications used to treat PBC (such as UDCA) or the use of colchicine, corticosteroids, azathioprine, chlorambucil, methotrexate, or D-penicillamine within the last 6 months.
3. Advanced liver disease or esophageal varices, INR \> 1.2 (upper limit of normal), Albumin \< 35 g/L (lower limit of normal), platelets \< 120,000/mm3, Childs Pugh class B or C cirrhosis, presence of varices or previous variceal hemorrhage, spontaneous encephalopathy, ascites or need for liver transplantation.
4. Patients with a secondary diagnosis such as HIV, 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. Clinically apparent pancreatitis or with a predicted survival of less than 3 years from malignant or other potentially life threatening disease.
5. An ultrasound showing a hepatic mass consistent with hepatocellular carcinoma within the last year in patients with cirrhosis.
6. Previous allergic reaction to study medications.
7. Creatinine clearance less than \< 70 mL/min using the Cockcroft Gault equation:
Creatinine clearance (mL/min) = (140 - age) x body wt (Kg) x 0.85 (if female)/serum creatinine in mol/l
8. Pregnancy or breast-feeding a child. Young sexually active patients not using contraception
9. Young sexually active patients not using contraception.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01614405
Study Brief:
Protocol Section:
NCT01614405