An Observational Study of Patients With Chronic Liver Disease
- Conditions
- CirrhosisChronic Liver Disease
- Interventions
- Other: Observational
- Registration Number
- NCT05744713
- Lead Sponsor
- Target PharmaSolutions, Inc.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 500000
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
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Disease Cohort Observational - Engaged Cohort Observational -
- Primary Outcome Measures
Name Time Method 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 To characterize the natural history of disease in patients with CLD from various etiologies and Cirrhosis 20 Years
- Secondary Outcome Measures
Name Time Method To evaluate longitudinal and patient reported outcomes in CLD/Cirrhosis 20 Years To evaluate provider management practices in the treatment of patients with CLD/Cirrhosis 20 Years
Trial Locations
- Locations (8)
Georgetown Medstar Transplant Institute
🇺🇸Washington, District of Columbia, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Stanford Medicine
🇺🇸Redwood City, California, United States
Atrium Health Center for Liver Disease and Transplant
🇺🇸Charlotte, North Carolina, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Columbia University Irving Medical Center/ New York Presbyterian Hospital
🇺🇸New York, New York, United States
Baylor Scott & White Research Institute
🇺🇸Dallas, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States