An Observational Study of Patients With Chronic Liver Disease

• Sponsor: Target PharmaSolutions, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05744713
• Collaborator: (none)
• Enrollment: 500,000
• Anticipated Duration (Months): 176

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Liver Disease; Cirrhosis	Other: Observational

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500000 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: An Observational Study of Patients With Chronic Liver Disease
• Anticipated Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: Dec 31, 2037
• Anticipated Study Completion Date: Dec 31, 2037

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. To characterize the natural history of disease in patients with CLD from various etiologies and Cirrhosis [20 Years]

2. To assess safety and effectiveness of CLD/Cirrhosis treatments and treatments for complications of any chronic liver disease [20 Years]

3. To establish learning health networks focused on quality of care for patients [20 Years]

Secondary Outcome Measures

1. To evaluate provider management practices in the treatment of patients with CLD/Cirrhosis [20 Years]

2. To evaluate longitudinal and patient reported outcomes in CLD/Cirrhosis [20 Years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Target PharmaSolutions, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Target PharmaSolutions, Inc.
• ClinicalTrials.gov Identifier: NCT05744713
• Other Study ID Numbers: TARGET-LD
• First Posted: Feb 27, 2023
• Last Update Posted: Feb 27, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Diseases

Study Results

No Results Posted as of Feb 27, 2023