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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT01292304
Eligibility Criteria:
Inclusion Criteria:
* Patients with cirrhosis of liver confirmed by histology and/or combination of ultrasound or endoscopic examination with laboratory evidence
* Clinically evident ascites treated by diet and/or diuretics
* History of 1 or more therapeutic paracentesis in the previous 6 months.
Exclusion Criteria:
* History of variceal bleeding
* Current or history of Gastrointestinal bleeding within 10 days of screening
* Ascites from another cause other than liver cirrhosis (i.e. cardiac origin, peritoneal infection, or peritoneal carcinoma)
* INR (International normalized ratio) \> 3.0, neutrophils \<1500 cell/μl, platelets \< 40,000/μl
* serum bilirubin \> 3 mg/dl
* serum sodium \< 125 meQ (milliequivalent)/L
* serum potassium \<3.5 meQ/L
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01292304
Study Brief:
Protocol Section:
NCT01292304