Skip to content

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.

Prospective Observational Study To evaluate Biomarkers of Metabolic Dysfunction Among Patients with Liver Failure

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/09/045668
Enrollment
120
Registered
2022-09-19
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K769- Liver disease, unspecified

Interventions

None listed

Sponsors

Ryan Huss
Lead Sponsor

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

MeasureTime frame
This is a natural history and sample procurement study, and thus, there are no prespecified primary or secondary endpoints.Timepoint: 02 years

Secondary

MeasureTime 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

Public ContactRanjeet Rathore

KlinEra Global Services

sherin.eddin@klinera.com02225091470

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026