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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT00737594
Eligibility Criteria:
Inclusion Criteria:
* Patient is \>= 18 years of age.
* Patient has clinical and/or pathological diagnosis of intra-hepatic portal hypertension.
* Patient has clinical diagnosis of cirrhosis.
* Patient has undergone variceal banding.
Exclusion Criteria:
* Patient has a Child-Pugh score \>12.
* Patient has portal hypertension resulting from hepatic vein obstruction, portal vein occlusion, schistosomiasis, portal vein thrombosis, splenic vein thrombosis, or Budd-Chiari syndrome.
* Variceal banding procedure was performed within 1 month of the screening visit.
* Patient has active or recurrent variceal bleeding, or has had variceal bleeding within the 12 weeks prior to screening.
* Patient is unwilling to discontinue use of vasoactive drugs from the screening visit through the end of the study.
* Patient has hepatocellular carcinoma that is being medically treated or is advanced.
* Patient has impaired renal function (i.e., serum creatinine concentration \>1.8 mg/dl)
* Patient has a history of liver transplant, or is expected to receive a liver transplant during the study period.
* Patient has undergone a gastrointestinal or abdominal surgical procedure within 90 days prior to the Screening Visit, or has had a bowel resection at any time.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00737594
Study Brief:
Protocol Section:
NCT00737594