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 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT01085760
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of PSC established by alkaline phosphatase \>1.5 times and/or two fold elevation of liver transaminases (AST and/or ALT) for at least 6 months duration.
* Cholangiography demonstrating intrahepatic and/or extrahepatic biliary obstruction, beading, or narrowing consistent with PSC.
* Both genders.
* Age ≥ 18 years old and \< than 75 years old.
* Patient's informed consent for study participation.
Exclusion Criteria:
* Treatment with systematic antibiotics, azulfidine, ursodeoxycholic acid, corticosteroids, colchicine, methotrexate, azathioprine, cyclosporine, chlorambucil, budesonide, pentoxifylline, tacrolimus, silymarin or prednisone in the preceding three months.
* Active drug or alcohol use.
* Prior history of allergic reactions to the antibiotics which will be used in the study.
* Any condition that, in the opinion of the investigator, would interfere with the patients' ability to complete the study safely or successfully.
* Evidence of decompensated liver disease such as recurrent variceal bleeding, refractory ascites or spontaneous hepatic encephalopathy.
* Anticipated need for transplantation in one year (Mayo survival model \<80% one-year survival without transplant).
* Findings highly suggestive of liver disease of other etiology such as chronic alcoholic liver disease, chronic hepatitis B or C infection, hemochromatosis, Wilson's disease, 1-antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis or secondary sclerosing cholangitis.
* Pregnancy or current lactation. Subjects becoming pregnant during the study will be withdrawn.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01085760
Study Brief:
Protocol Section:
NCT01085760