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: Enrolling by invitation
• Conditions: Cirrhosis; Chronic Liver Disease
• Intervention / Treatment: Other: Observational

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

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Keck School of Medicine of USC
    • Redwood City, California, United States, 94063
      • Stanford Medicine
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • Georgetown Medstar Transplant Institute
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center/ New York Presbyterian hospital
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Atrium Health Center for Liver Disease and Transplant
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University - Lewis Katz School of Medicine
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor Scott & White Research Institute
    • Houston, Texas, United States, 77021
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

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

• 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 (Actual): February 19, 2024
• Primary Completion (Estimated): December 31, 2037
• Study Completion (Estimated): December 31, 2037

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fibrosis; Health Services Administration; Quality of Health Care; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Watchful Waiting
• 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
• product manufactured in and exported from the U.S.: No