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 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT00158769
Eligibility Criteria:
Inclusion criteria:
* Patients with known history of liver disease (either with or without history of alcohol abuse).
* Previous confirmation of liver cirrhosis by liver biopsy or other medical imaging technique.
* Child-Pugh score of 7-9 (moderate impairment) BMI 19-29 Kg/m2.
* Healthy volunteers to match the hepatically impaired subjects in a 1:1 ratio by gender, age, BMI.
Exclusion criteria:
* Lactating or pregnant females.
* Subjects with BP \> 160/90.
* Subjects who, within the past six months, have had a history of significant drug or alcohol abuse, or any indication of regular use of more than 14 units of alcohol per week for women, or 21 units/week for men.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00158769
Study Brief:
Protocol Section:
NCT00158769