Cirrhosis Research Studies

Cirrhosis is a condition in which the liver slowly deteriorates and is unable to function normally due to chronic, or long lasting, injury. Scar tissue replaces healthy liver tissue and partially blocks the flow of blood through the liver.

Investigators

Naga P. Chalasani, MD

David W. Crabb Professor of Gastroenterology and Hepatology

Archita Desai, MD

Assistant Professor of Medicine

Marwan S. Ghabril, MD

Professor of Medicine

Craig Lammert, MS, MD

Associate Professor of Medicine

Eric Orman, MD

Associate Professor of Medicine

Niharika Samala, MD

Assistant Professor of Medicine

Raj Vuppalanchi, MD

Professor of Medicine

Open Research Studies for Cirrhosis

A Study for Evaluation of BIV201 to Reduce Ascites and Complications in Patients With Cirrhosis and Refractory Ascites

Enrolling: No - On Hold

Principle Investigator: Eric Orman, MD

Duration: 1 year

Patient Population: Patients with refractory ascites

Drug(s): Terlipressin

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

View the study on clinicaltrials.gov

ALTUS: Performance of a Multi-Target Hepatocellular Carcinoma (HCC) Test in Subjects with Increased Risk

Enrolling: No

Principle Investigator: Naga Chalasani, MD

Duration: 6-8 months

Patient Population: Adults 18+, Child-Pugh A or B, no known cancer diagnosis < 5 years

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

The Cirrhosis Medical Home

Enrolling: No

Principle Investigator: Eric Orman, MD

Duration: Patients are enrolled for 6 months - total study duration is 2 years.

Patient Population: Patients with cirrhosis who have recently been discharged from the hospital and their caregivers.

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

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets for the Delay of Encephalopathy Decompensation in Cirrhosis (RED-C) RNLC3131 and RNLC3132

Enrolling: Yes

Principle Investigator: Marwan Ghabril, MD

Duration: 72 week treatment period with 4 week screening and 4 week follow-up

Patient Population: Adults with cirrhosis and no history of hepatic encephalopathy

Drug(s): Rifaximin SSD/placebo

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

View the study on clinicaltrials.gov

Galectin - Phase 2b/3

Enrolling: No

Principle Investigator: Raj Vuppalanchi, MD

Duration: 52 week treatment period with possibility of 52 additional weeks.

Patient Population: Patients 18-75 years old with NASH cirrhosis and no varices.

Drug(s): Belapectin every 2 week infusion.

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

Midwest Cirrhosis Consortium

Enrolling: Yes

Principle Investigators: Marwan Ghabril, MD and Eric Orman, MD

Duration: 1 visit

Patient Population: Adults over the age of 18 with a diagnosis of cirrhosis admitted to the ICU, PCU and wards as an inpatient.

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

Safety and Efficacy of Ketogenic Diet for PromotingWeight Loss in Obese Individuals with Compensated NASH Cirrhosis

Enrolling: Yes

Principle Investigator: Raj Vuppalanchi, MD

Duration: 16 weeks

Patient Population: Patients over the age of 18 with a diagnosis of NASH cirrhosis with a BMI >30kg/m2.

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

Tocotrienol

Enrolling: Yes

Principle Investigator: Raj Vuppalanchi, MD

Duration: 5 years

Patient Population: Adults over the age 18 with a diagnosis of cirrhosis admitted to the ICU.

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

View the study on clinicaltrials.gov

Sarcopenia in NASH Cirrhosis

Enrolling: Yes

Principle Investigator: Niharika Samala, MD

Duration: 2 years (estimated - until 50 patients are enrolled)

Patient Population: Age-matched males and females with NASH cirrhosis; Females must be post-menopausal

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

Closed Cirrhosis Studies

ALC Database

Enrolling: No

Principle Investigator: Craig Lammert, MD

Duration: 1 visit

Patient Population: Alcoholic liver cirrhosis, no viral hepatitis, pre/post-transplant
Cirrhosis Readmit. Inpatient

Enrolling: No

Principle Investigator: Archita Desai, MD

Duration: 3-5 years

Patient Population: Inpatients over the age of 18 with cirrhosis.
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of AXA1665 in Subjects With Liver Cirrhosis and Prior Overt Hepatic Encephalopathy (EMMPOWER)

Enrolling: No Principle Investigator: Marwan Ghabril, MD
Duration: 24 week treatment period with 4 week screening and 4 week follow-up

Patient Population: Adults with cirrhosis and history of hepatic encephalopathy

Drug(s): AXA1665/Placebo

View this study on clinicaltrials.gov
ICU Study

Enrolling: No

Principle Investigator: Kavish Patidar, DO

Duration: 5 years

Patient Population: Adults over the age of 18 with a diagnosis of cirrhosis admitted to the ICU.
Orman Fitness Pilot Study

Enrolling: No
Principle Investigator: Eric Orman, MD

Duration: 3 months

Patient Population: 18 and older

Cirrhotic Database

Enrolling: No

Duration: 1 visit.
UCD Database

Enrolling: No

Duration: 1 visit.
HRQoL Comparison Study

Enrolling: No

Principle Investigator: Naga Chalasani, MD

Duration: 3 - 5 years

Patient Population: Patients that are over 18 years old with liver disease
Cirrhosis OP QoL

Enrolling: No
Principle Investigator: Archita Desai, MD
Duration: 3 -5 years
Patient Population: Patients over the age of 18 with cirrhosis.
A Phase 1 Single Dose Escalation Study of PHIN-214 in Compensated and Decompensated Cirrhotic Patients

Enrolling: No
Principle Investigator: Eric Orman, MD

Duration: 1 year

Patient Population: Patients with confirmed liver cirrhosis (biopsy or reliable fibroscan > 15 kPA), BMI within the range 18 to 40 kg/m2 (inclusive) at screening, females must be non-pregnant, non-lactating or of non-childbearing potential or using highly efficient contraception for the full duration of the study.

Drug(s): PHIN-214