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Other Clinical Liver Research Studies

Investigators

Naga P. Chalasani, MD

David W. Crabb Professor of Gastroenterology and Hepatology

Craig Lammert, MD

Assistant Professor of Medicine

Suthat Liangpunsakul, MD, MPH

Professor of Medicine

Lauren D. Nephew, MD, MAE, MSC, BA

Assistant Professor of Medicine

Eric Orman, MD

Associate Professor of Medicine

Raj Vuppalanchi, MD

Professor of Medicine

Arrowhead

Enrolling: No

Principle Investigator: Raj Vuppalanchi, MD

Duration: Upwards of 2 years

Patient Population: F2 - 3

Drug(s): ARO-AAT

Interested in this study? Please contact the following coordinator:
Holly King
hrking1@iu.edu

Fibroscan Database

Enrolling: Yes

Principle Investigator: Naga Chalasani, MD

Duration: 1 visit

Interested in this study? Please contact the following coordinator:
Anusha Vallapuri
avallapu@iu.edu

Hepatic Adenoma Biorepository

Enrolling: Yes

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 following coordinator:
Kelsey Green
greenke@iu.edu

Liver Biopsy Collection

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 following coordinators:

Jake McCarty

jacmccar@iu.edu

 

Dheeksha Ranginani

drangina@iu.edu

 

Anusha Vallapuri

avallapu@iu.edu

 

Ashwin Penchala

apenchal@iu.edu

Palliative Care Within ESLD

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 following coordinator:

Nicole Garcia

garcini@iu.edu

Post Liver Transplant Quality of Life Sub-Study

Enrolling: Yes

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 following coordinator:

Janeth Castano

jccastan@iu.edu

Transitional Liver Clinic (TLC) - A Randomized Trial of Post-Discharge Transitional Care for Patients with Chronic Liver Disease

Enrolling: No - Anticipated in 2023

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 project leader:

Lindsay Yoder, MPAS, PA-C

LYoder4@iuhealth.org

Ultragenyx Wilson’s

Enrolling: Yes

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 following coordinator:

Kelsey Green

greenke@iu.edu

Understanding Racial Disparities in Curative Therapies for Hepatocellular Carcinoma: A Prospective Cohort Study

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 following coordinator:

Nicole Garcia

garcini@iu.edu

Closed Studies

  • TREAT 005

    Enrolling: No

    Duration: 42 days

    Patient Population: Adults 21-65 years old, healthy controls with no alcohol use or heavy alcohol drinkers without liver disease.

  • Cystic Fibrosis Study

    Enrolling: No

    Principle Investigator: Naga Chalasani, MD

    Duration: 1 visit

    Patient Population: Aged 18 or greater with a diagnosis of cystic fibrosis.

  • Velcaur (Portal Hypertension)

    Enrolling: No

    Principle Investigator: Samer Gawrieh, MD

    Duration: 5 years

    Patient Population: 21+ chronic liver disease, with upper endoscopy or transjugular liver biopsy with pressure measurements within 6 months of visit