Other Clinical Liver Research Studies

Enrolling: On hold

Principle Investigator: Craig Lammert, MD

Duration: 1 visit

Patient Population: Hepatic adenoma with history of oral contraceptive use.

Interested in this study? Please contact the clinical liver research team: iuliverr@iu.edu

Enrolling: Yes

Principle Investigator: Naga Chalasani, MD

Duration: 1 visit

Patient Population: Patients receiving liver biopsies excluding those with viral hepatitis and alcoholic liver disease.

Interested in this study? Please contact the clinical liver research team: iuliverr@iu.edu

Enrolling: Yes

Principle Investigator: Eric Orman, MD

Duration: 1 year, 7 visits required, but 4 can be completed over the phone.

Patient Population: Adults over 18 years old with new onset or ongoing complications of End Stage Liver Disease (ESLD) including Hepatocellular Cancer (HCC), with a caregiver willing to participate.

Interested in this study? Please contact the clinical liver research team: iuliverr@iu.edu

Enrolling: No

Principle Investigator: Naga Chalasani, MD

Duration: 1 visit

Patient Population: Patients that are over 18 years old that have had a liver transplant.

Interested in this study? Please contact the clinical liver research team: iuliverr@iu.edu

Enrolling: No - Anticipated in 2023

Principle Investigator: Eric Orman, MD

What is TLC? The TLC is an APP-centric post-hospital discharge Transitional Care Management program. It includes a telephone call within 2 business days of discharge followed by a face-to-face or virtual visit within14days with an APP. Context-sensitive and protocolized care is provided during the 30-day transitional care period.

This is a 45-month stepped wedge cluster randomized trial in which, every 9 months, one randomly chosen site is crossed over from usual care to the TLC intervention. All sites begin the trial using usual care and all sites end the trial using TLC. All sites recruit participants for the entire 45 months. 

Unique Aspects of the Project: Patients with the complications of advanced liver disease often have difficulties after hospital discharge that result in early readmission. Poor outcomes for these patients during this transitional time could be improved through the use of innovative transitional care models. This project aims to examine the effect of a transitional care model, The Transitional Liver Clinic (TLC), led by APPs, in reducing readmissions, improving quality of life, and improving patient experience.

Duration of Participation: Each patient will participate for 90-days post-hospital discharge with follow-up phone calls at 30-days and 90-days. 

Duration of Study: 5 years after anticipated start of enrollment in 2023.

Objectives: To assess the effect of TLC versus usual care on 30-day readmission rate, QoL, and patient satisfaction for patients with advanced liver disease after hospital discharge:

• Specific Aim 1 To test the effect of the TLC compared to usual care on 30-day readmissions for patients hospitalized with complications of advanced liver disease. Secondary outcomes will include preventable readmissions, 90-day readmissions and 30- and 90-day emergency room visits, mortality, and days alive out of the hospital.

• Specific Aim 2 To test the effect of the TLC compared to usual care on quality of life for patients hospitalized with complications of advanced liver disease. Quality of life will be assessed at 30- and 90-days post-discharge using the PROMIS-29+2 Profile.

• Specific Aim 3 To test the effect of the TLC compared to usual care on patient satisfaction for patients hospitalized with complications of advanced liver.

Treatment: Protocolized post-hospital comprehensive discharge care (Transitional Liver Clinic [TLC]) run by Advanced Practice Providers (NPs/PAs) for patients with decompensated liver disease versus standard of care after hospital discharge.

Patient Population: Participants will be aged 18 and greater who haveadvanced liver disease and are soon to be discharged from the hospital. 

Anticipated Enrollment: 1,000 patients.

Current Participating Sites:

• Indiana University, Indianapolis, IN
• University of Michigan, Ann Arbor, MI
• Albert Einstein Health Network, Philadelphia, PA
• University of Chicago, Chicago, IL

Sponsor and Funding Support: NIDDK and NIH R01.

Interested in this study? Please contact the following project leader and clinical liver research team:

Lindsay Yoder, MPAS, PA-C

LYoder4@iuhealth.org

iuliverr@iu.edu

Principle Investigator: Craig Lammert, MD

Duration: 3 years

Patient Population: 18 and older, diagnosed with Wilson's disease.

Drug(s): Gene therapy product

Interested in this study? Please contact the clinical liver research team: iuliverr@iu.edu

Enrolling: Yes

Principle Investigator: Lauren Nephew, MD

Duration: 1 visit

Patient Population: Patients that are over 18 years old that have had a liver transplant.

Interested in this study? Please contact the clinical liver research team: iuliverr@iu.edu

Enrolling: No - On Hold

Principle Investigator: Archita Desai, MD

Study Duration: 14 weeks

Patient Population: Patients between 40-70 yrs. old, listed for Liver Transplant, with Cirrhosis and MELD scores higher than 10.

Interested in this study? Please contact the clinical liver research team: iuliverr@iu.edu

Principle Investigator: Naga Chalasani, MD and Niharika Samala, MD

Duration: 3 years minimum with option to extend

Patient Population: Any adult patient with liver disease can participate in the Indiana Biobank protocol, any patient undergoing a liver biopsy or transplant can participate in the Liver Tissue Biobank protocol.

Interested in this study? Please contact the clinical liver research team: iuliverr@iu.edu

Enrolling: Yes

Principle Investigator: Raj Vuppalanchi, MD

Duration: 4 years

Patient Population: Patients with Alpha-1 Antitrypsin with ZZ genotype and Stage F2 to F4 liver fibrosis

Drug(s): Fazirsiran

Interested in this study? Please contact the clinical liver research team: iuliverr@iu.edu

Enrolling: Yes

Principle Investigator: Lauren Nephew, MD

Duration: TBD

Patient Population: Liver transplant.

Interested in this study? Please contact the clinical liver research team: iuliverr@iu.edu

Enrolling: Yes

Principle Investigator: Lauren Nephew, MD

Duration: 2 years

Patient Population: Patients diagnosed with hepatocellular carcinoma, pre/post liver transplant.

Interested in this study? Please contact our clinical liver research team: iuliverr@iu.edu

Enrolling: No

Principle Investigator: Lauren Nephew, MD

Duration: TBD

Patient Population: Patients diagnosed with hepatocellular carcinoma, pre/post liver transplant.

Interested in this study? Please contact our clinical liver research team: iuliverr@iu.edu

Enrolling: No

Principle Investigator: Lauren Nephew, MD

Duration: TBD

Patient Population: Patients diagnosed with hepatocellular carcinoma, pre/post liver transplant.

Interested in this study? Please contact our clinical liver research team: iuliverr@iu.edu

Enrolling: Yes

Principle Investigator: Lauren Nephew, MD

Duration: 3 years.

Patient Population: Patients who are pre-transplant.

Interested in this study? Please contact our clinical liver research team: iuliverr@iu.edu