An Observational Study of Patients With Chronic Liver Disease

Cirrhosis Clinical Trial

Official title:

An Observational Study of Patients With Chronic Liver Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05744713
• Other study ID #: TARGET-LD
• Status: Not yet recruiting
• Start date: May 1, 2023
• Est. completion date: December 31, 2037

Study information

• Verified date: February 2023
• Source: Target PharmaSolutions, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500000
• Est. completion date: December 31, 2037
• Est. primary completion date: December 31, 2037
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Liver Disease
• Cirrhosis
• Liver Diseases

Intervention

Other:
• Observational
Observational

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Target PharmaSolutions, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To characterize the natural history of disease in patients with CLD from various etiologies and Cirrhosis		20 Years
Primary	To assess safety and effectiveness of CLD/Cirrhosis treatments and treatments for complications of any chronic liver disease		20 Years
Primary	To establish learning health networks focused on quality of care for patients		20 Years
Secondary	To evaluate provider management practices in the treatment of patients with CLD/Cirrhosis		20 Years
Secondary	To evaluate longitudinal and patient reported outcomes in CLD/Cirrhosis		20 Years