This is a prospective, multicenter, observational study to evaluate the relationship between traditional clinical signs and symptoms as well as genetic, immunologic, and other biomarkers of metabolic dysfunction with clinical outcomes in patients with advanced liver disease.
- Conditions
- Health Condition 1: K769- Liver disease, unspecified
- Registration Number
- CTRI/2022/09/045668
- Lead Sponsor
- Ryan Huss
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Willing and able to provide informed consent prior to any study specific procedures being performed. For subjects with altered sensorium in the opinion of the investigator, informed consent may be obtained from a legally authorized representation (LAR).
2.Men and women, 18 years of age or older, inclusive, based on the date of the screening visit
3.Liver cirrhosis of any etiology (Child Pugh [CP]-A or above)
4.Reliable access to a personal smartphone for purposes of mobile device application-based symptom reporting
Subjects meeting any of the following criteria will not be eligible to participate in the study:
1.Women who are pregnant or breastfeeding
2.Significant comorbidity other than liver disease in the opinion of the investigator
3.History of immunosuppression or a live-in relative of immunosuppressed patients
4.Any other clinical condition(s) that in the opinion of the investigator would make the subject unsuitable for the study
5.For wearable substudy only: Wrist circumference >8.9 inches
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method This is a natural history and sample procurement study, and thus, there are no prespecified primary or secondary endpoints.Timepoint: 02 years
- Secondary Outcome Measures
Name Time Method This is a natural history and sample procurement study, and thus, there are no prespecified primary or secondary endpoints.Timepoint: 02 years