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 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT02488993
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of cirrhosis;
* Patient is ≥18 years of age;
* Patient is enrolled within 12 weeks of resolution of an episode of overt HE associated with a hospital visit;
* Patient is able to provide informed consent to participate in the study (individually or via caregiver);
* Patient meets clinical eligibility to receive rifaximin-α 550 mg in the opinion of the participating physician, regardless of HE treatment actually received.
Exclusion Criteria:
* West Haven Conn score of ≥2 at time of study entry (i.e. at provision of informed consent);
* Mental health disorder such as dementia or psychosis which makes diagnoses of HE questionable;
* Prior treatment with rifaximin in the 12 months before qualifying episode of overt HE associated with a hospital visit;
* Contraindications to the use of rifaximin-α as per local summary of product characteristics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02488993
Study Brief:
Protocol Section:
NCT02488993