Health Condition 1: K769- Liver disease, unspecified
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This is a natural history and sample procurement study, and thus, there are no prespecified primary or secondary endpoints.Timepoint: 02 years | — |
Secondary
| Measure | Time frame |
|---|---|
| This is a natural history and sample procurement study, and thus, there are no prespecified primary or secondary endpoints.Timepoint: 02 years | — |
Countries
India
Contacts
KlinEra Global Services