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:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT00006166
Eligibility Criteria:
Inclusion Criteria:
* Cirrhosis as documented by biopsy or clinical/laboratory parameters WITH
* Tense symptomatic ascites and need for paracentesis (10 L) within last 2 months AND
* Failure of medical therapy as defined by the inability to lose at least 3.3 lbs/week while on maximum doses of diuretics or diuretic related complications (severe hyponatremia, hypercalcemia, azotemia or encephalopathy)
Exclusion Criteria:
* Causes of ascites other than cirrhosis and portal hypertension
* Terminal liver failure
* Portal vein thrombosis
* Congestive heart failure
* Acute renal failure
* Active encephalopathy
* Alcoholic hepatitis
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00006166
Study Brief:
Protocol Section:
NCT00006166