An Observational Study of Patients With Chronic Liver Disease

TARGET-Liver Disease (TARGET-LD) is an observational research study to conduct a comprehensive review of outcomes for patients with chronic liver disease (CLD).

Study Overview

• Status: Not yet recruiting
• Conditions: Cirrhosis; Chronic Liver Disease
• Intervention / Treatment: Other: Observational

• Study Type: Observational
• Enrollment (Anticipated): 500000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study will include adults who are being managed for chronic liver disease or cirrhosis of any etiology.

Description

Inclusion Criteria:

Disease Cohort

•Adult* patients at the time of enrollment with a diagnosis of CLD/cirrhosis by ICD-10 code in the EHR interface

Engaged Cohort

• Adult* patients diagnosed and managed for CLD/cirrhosis invited to participate
• Ability to provide written informed consent

Exclusion Criteria:

Disease Cohort

• Death
• Manual removal (sponsor or site request)
• No EHR interface encounter > 3 years.

Engaged Cohort

• Patient expressed desire to withdraw consent to complete PROs
• Failure to complete PROs within 24 weeks of initial invitation
• Greater than 24 months lapse of survey completion after baseline surveys completed
• Additionally, the criteria detailed for Disease Cohort apply to the Engaged Cohort.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Disease Cohort	Other: Observational; Observational
Engaged Cohort	Other: Observational; Observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To characterize the natural history of disease in patients with CLD from various etiologies and Cirrhosis	20 Years
To assess safety and effectiveness of CLD/Cirrhosis treatments and treatments for complications of any chronic liver disease	20 Years
To establish learning health networks focused on quality of care for patients	20 Years

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate provider management practices in the treatment of patients with CLD/Cirrhosis	20 Years
To evaluate longitudinal and patient reported outcomes in CLD/Cirrhosis	20 Years

Collaborators and Investigators

• Sponsor: Target PharmaSolutions, Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): December 31, 2037
• Study Completion (Anticipated): December 31, 2037

Study Registration Dates

• First Submitted: February 15, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Estimate): February 27, 2023

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: TARGET-LD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No