Chronic Liver DiseaseNCT05744713
An Observational Study of Patients With Chronic Liver Disease
An observational study of Chronic Liver Disease and Cirrhosis, run by Target PharmaSolutions, Inc. at 10 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Liver Disease, Cirrhosis
- What is being tested?
- Observational
- How many people
- 500,000 participants
- Where
- 10 sitesUnited States
- Study dates
- 19 Feb 2024to 31 Dec 2037
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include adults who are being managed for chronic liver disease or cirrhosis of any etiology.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites
Atrium Health Center for Liver Disease and Transplant
Charlotte, North Carolina, 28204
Rush University Medical Center
Chicago, Illinois, 60612
Baylor Scott & White Research Institute
Dallas, Texas, 75246
Baylor College of Medicine
Houston, Texas, 77021
Keck School of Medicine of USC
Los Angeles, California, 90033
Columbia University Irving Medical Center/ New York Presbyterian Hospital
New York, New York, 10032
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Temple University - Lewis Katz School of Medicine
Philadelphia, Pennsylvania, 19140
Stanford Medicine
Redwood City, California, 94063
Georgetown Medstar Transplant Institute
Washington D.C., District of Columbia, 20007
About this study
TARGET-Liver Disease (TARGET-LD) is an observational research study to conduct a comprehensive review of outcomes for patients with chronic liver disease (CLD).
- Conditions
- Chronic Liver Disease, Cirrhosis
- Being tested
- Observational
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational
| Study group | Role | What they receive |
|---|---|---|
| Disease Cohort | Not described Receives: Other: Observational | |
| Engaged Cohort | Not described Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the natural history of disease in patients with CLD from various etiologies and Cirrhosis
Measured: 20 Years
To assess safety and effectiveness of CLD/Cirrhosis treatments and treatments for complications of any chronic liver disease
Measured: 20 Years
To establish learning health networks focused on quality of care for patients
Measured: 20 Years
Secondary outcomes (2)
To evaluate provider management practices in the treatment of patients with CLD/Cirrhosis
Measured: 20 Years
To evaluate longitudinal and patient reported outcomes in CLD/Cirrhosis
Measured: 20 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start19 Feb 2024
- Primary completion31 Dec 2037 (estimated)
- Study completion31 Dec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Target PharmaSolutions, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744713
- Sponsor's protocol ID
- TARGET-LD
- Status last verified
- Mar 2026
- First submitted
- 15 Feb 2023
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Patients With Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT05744713
- Acronym / sponsor ID
- TARGET-LD
- Conditions
- Chronic Liver Disease, Cirrhosis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500,000 participants (estimated)
- Lead sponsor
- Target PharmaSolutions, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 31 Dec 2037 (estimated)
- Study completion
- 31 Dec 2037 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disease Cohort | – | Other: Observational |
| Engaged Cohort | – | Other: Observational |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include adults who are being managed for chronic liver disease or cirrhosis of any etiology.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Disease Cohort
- Death
- Manual removal (sponsor or site request)
- No EHR interface encounter > 3 years.
- Engaged Cohort
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalObservational | Other | Disease Cohort, Engaged Cohort |
Primary outcome
To characterize the natural history of disease in patients with CLD from various etiologies and Cirrhosis
Time frame: 20 Years
To assess safety and effectiveness of CLD/Cirrhosis treatments and treatments for complications of any chronic liver disease
Time frame: 20 Years
To establish learning health networks focused on quality of care for patients
Time frame: 20 Years
2 secondary outcomes
To evaluate provider management practices in the treatment of patients with CLD/Cirrhosis
Time frame: 20 Years
To evaluate longitudinal and patient reported outcomes in CLD/Cirrhosis
Time frame: 20 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Liver Disease and Cirrhosis, run by Target PharmaSolutions, Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To characterize the natural history of disease in patients with CLD from various etiologies and Cirrhosis (time frame: 20 Years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.