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 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT00588302
Eligibility Criteria:
Inclusion Criteria:
* PBC patients treated with UDCA (daily dose of 13 to 15 mg/kg for at least 6 months) and an incomplete response defined by persistent elevation of serum alkaline phosphatase activity at least 2 times the upper limit of normal
Exclusion Criteria:
* age less than 18 years
* pregnancy or nursing
* anticipated need for liver transplantation within 1 year with less than a 80% one-year survival determined by the Mayo risk score
* complications of cirrhosis such as recurrent variceal hemorrhage, portosystemic encephalopathy, and refractory ascites
* history of coexistent severe cardiovascular disease including aortic stenosis
* history of coexistent severe renal disease (defined as elevation of serum creatinine more than 1.5 mg/dL) including renal artery stenosis
* history of allergy to ACE inhibitors
* current use of an ACE inhibitors or AT1 receptor antagonists in the past 3 months
* previous treatment with immunosuppressive agents or any experimental drug in the preceding 3 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT00588302
Study Brief:
Protocol Section:
NCT00588302