SCHOOL OF MEDICINE

Department of Medicine

Gastroenterology Hepatology

Liver Research

LIVER RESEARCH

CLINICAL TRIALS OPEN TO ENROLLMENT

Study Title

Study Information

Coordinator to Contact

Principle Investigator 

Intercept 302 PBC Study

 

 

 

 

Liver Disorder: Primary Biliary Cholangitis

Intervention: Obeticholic Acid tablet or placebo

Participation: 6-8 years

Patient Population: PBC with total Bili >ULN and ≤3x ULN or ALP >5x ULN
 

Rachel Lee, RN

Phone:(317) 278-6266 

Email:Lee352@iu.edu  

 

 

Dr. Raj Vuppalanchi

 

Gilead 428-4025

 

 

 

 

 

Liver Disorder: Primary Sclerosing Cholangitis

Intervention: GS-9674 or Placebo, daily oral tablet

Participation: 2.5 years

Patient Population: Adults with PSC and without cirrhosis, and alkaline phosphatase ≥ 1.67 x upper limit of the normal range (ULN); Total Bilirubin < 2x upper limit of the normal range

Rachel Lee, RN

Phone:(317) 278-6266

Email:Lee352@iu.edu

 

 

 

Dr. Raj Vuppalanchi

 

 

Intercept 303 NASH

 

 

 

 

 

Liver Disorder: Non-Alcoholic Fatty Liver Disease

Intervention: Obeticholic Acid tablet or Placebo

Participation: Up to 6 years

Patient Population: Adults with Non-alcoholic Steatohepatitis, Fibrosis stage 2-3

 

Rachel Lee, RN

Phone: (317) 278-6266

Email: Lee352@iu.edu     

 

 

 

Dr. Raj Vuppalanchi

 

 

 EPICS

 

 

 

 

 

Liver Disorder: Primary Biliary Cholangitis

Intervention: Saroglitazar Magnesium or Placebo, daily oral tablet

Participation: 12 weeks

Patient Population: Adults with PBC and alkaline phosphatase ≥1.67x upper limit of normal (ULN) at Visit 1 and Visit 2, and normal total bilirubin and INR. 

Rachel Lee, RN

Phone: (317) 278-6266

Email: Lee352@iu.edu

 

 

 

Dr. Raj Vuppalanchi

 

 

TREAT 002

 

 

 

 

Liver Disorder: Alcoholic Hepatitis

Intervention: Obeticholic Acid tablet or Placebo

Participation:  6 months

Patient Population: Adults with Alcoholic Hepatitis, MELD 12-19, active drinking within last 6 weeks

Jennifer Lehman, RN

Phone: (317) 278-1872

Email: Jgeck@iu.edu

 

 

Dr. Naga Chalasani

TREAT 003

 

 

 

 

 

Liver Disorder: Alcoholic Hepatitis

Intervention: Imm124-E (Bovine Colostrum Drug Substance or BCDS) or Placebo

Participation:  6 months

Patient Population: Adults with Alcoholic Hepatitis, MELD 20-28, active drinking within last 6 weeks

 

Jennifer Lehman, RN

Phone: (317) 278-1872

Email: Jgeck@iu.edu

 

 

 

Dr. Suthat Liangpunsakul

TREAT 005

 

 

 

 

 

Liver Disorder: Other

Intervention: Obeticholic Acid tablet or Placebo

Participation:  6 weeks

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

 

Jennifer Lehman, RN

Phone: (317) 278-1872

Email: Jgeck@iu.edu

 

 

 

Dr. Suthat Liangpunsakul

TREAT 008

 

 

 

 

 

Liver Disorder: Alcoholic Hepatitis

Intervention: IV infusions F-652 infusion, 10 μg/kg, 30 μg/kg or 45 μg/kg 

Participation:  11 weeks

Patient Population: Adults 18-75 years with Non-alcoholic Steatohepatitis

 

Jennifer Lehman, RN

Phone: (317) 278-1872

Email: Jgeck@iu.edu

 

 

 

Dr. Suthat Liangpunsakul

Conatus NASH

 

 

 

 

 

Liver Disorder: Non-Alcoholic Fatty Liver Disease

Intervention: Emricasan tablet- 5mg, 25mg, 50mg, or Placebo  

Participation:  8 months

Patient Population: Adults 18 years and older with sever portal hypertension presenting with a baseline HVPG ≥12 mmHg.

Charlene Jones, RN

Phone: (317) 278-9215

Email:Jones572@iu.edu

Nina Garret, RN

Phone: (317) 278-9245

Email:Ninagarr@iu.edu

Dr. Naga Chalasani

 

 

OBSERVATIONAL & DATABASE STUDIES

Study Title

Study Information

Coordinator to Contact

Principle Investigator 

PBC Database

 

 

 

 

 Liver Disorder: Primary Biliary Cholangitis

 Intervention: N/A

 Participation:  1 visit

 Patient Population: PBC/Pre- and Post-  Transplant/Overlap

 Breann McGee

 Phone: (317) 278-9291

 Email:Mcgeebr@iu.edu

 

 

Dr. Craig Lammert

 

GRACE: Autoimmune Hepatitis Database

 

 

 

 Liver Disorder: Autoimmune Hepatitis

 Intervention: N/A

 Participation:  1 visit

 Patient Population: Autoimmune Hepatitis/Pre- and Post-  Transplant/Overlap

 Breann McGee

 Phone: (317) 278-9291

 Email:Mcgeebr@iu.edu

 

 

Dr. Craig Lammert

 

Hepatic Adenoma Biorepository

 

 

 

 Liver Disorder: Other

 Intervention: N/A

 Participation:  1 visit

 Patient Population: Hepatic adenoma with hx oral  contraceptive use

 Breann McGee

 Phone: (317) 278-9291

 Email:Mcgeebr@iu.edu

 

 

Dr. Craig Lammert

 

ALC Databas

 

 

 

 

 

 Liver Disorder: Cirrhosis

 Intervention: N/A

 Participation:  1 visit

 Patient Population: Alcoholic Liver Cirrhosis/No Viral  Hepititis/Pre- and Post- Transplant

 

 Breann McGee

 Phone: (317) 278-9291

 Email:Mcgeebr@iu.edu

 

 

 

Dr. Suthat Liangpunsakul

Cirrhotic Database

 

 

 

 

 

 Liver Disorder: Cirrhosis

 Intervention: N/A

 Participation:  1 visit

 Patient Population: Cirrhosis/Only Pre- Transplant

 

 

 Breann McGee

 Phone: (317) 278-9291

 Email:Mcgeebr@iu.edu

 

 

 

Dr. Suthat Liangpunsakul

UCD Database

 

 

 

 

 Liver Disorder: Cirrhosis

 Intervention: N/A

 Participation:  1 visit

 Patient Population: Cirrhosis with and without hepatic  encephalopathy 

 Regina Weber

 Phone: (317) 278-3584

 Email:Reginaw@iu.edu

 

 

Dr. Marwan Ghabril

PBC Itch Study 

 

 

 

 

 Liver Disorder: Primary Biliary Cholangitis

 Intervention: N/A

 Participation:  1 visit

 Patient Population: PBC/Pre-Transplant and hx of  no/minimal itch or severe itch 

 Breann McGee

 Phone: (317) 278-9291

 Email:Mcgeebr@iu.edu

 

 

 Dr. Naga Chalasani

 Molecular Stethoscope Study

 

 

 

 

 Liver Disorder: NAFLD, NASH

 Intervention: N/A

 Participation:  1 visit

 Patient Population: Patients with NAFLD/NASH with a  recent biopsy

 

 Breann McGee

 Phone: (317) 278-9291

 Email:Mcgeebr@iu.edu

 

 

 

Dr. Suthat Liangpunsakul

Prospective DILIN 

 

 

 

 Liver Disorder: Drug-induced Liver Injury

 Intervention: N/A

 Participation:  6-24 months

 Patient Population: DILI within 6 Months of Injury

 Wendy Morlan, RN

 Phone: (317) 278-9355

 Email:Wmorlan@iu.edu

 

Dr. Naga Chalasani

Dr. Raj Vuppalanchi

Dr. Marwan Ghabril

 

Prospective Acute DILIN 

 

 

 

 

 Liver Disorder: Drug-induced Liver Injury

 Intervention: N/A

 Participation:  6-24 months

 Patient Population: DILI enrolled within 16 days of "Date  of Onset

 Wendy Morlan, RN

 Phone: (317) 278-9355

 Email:Wmorlan@iu.edu

 

 

Dr. Naga Chalasani

Dr. Raj Vuppalanchi

Dr. Marwan Ghabril

 

 

Retrospective Acute DILIN

 

 

 

 

 Liver Disorder: Drug-induced Liver Injury

 Intervention: N/A

 Participation:  1 visit

 Patient Population: DILI beyond 6 months of event, back  to January 1, 1994

 

 Wendy Morlan, RN

 Phone: (317) 278-9355

 Email:Wmorlan@iu.edu

 

 

Dr. Naga Chalasani

Dr. Raj Vuppalanchi

Dr. Marwan Ghabril

 

 

TREAT 001

 

 

 

 

 Liver Disorder: Alcoholic Hepatitis

 Intervention: N/A

 Participation:  1 visit

 Patient Population: Acute Alcoholic Hepatitis, must be  drinking within 6 weeks

 Jennifer Lehman, RN

 Phone: (317) 278-1872

 Email: Jgeck@iu.edu

 

 

Dr. Naga Chalasani

Midwest Cirrhosis Consortium

 

 

Liver Disorder: Cirrhosis

Intervention:N/A

Participation:  Multiple visits while inpatient 

Patient Population: Inpatient Cirrhotics

Bri Melvin

Phone: (317) 278-9246

Email: Bhartlep@iu.edu

 

Dr. Marwan Ghabril

Dr. Eric Orman

 

 

Fibroscan Database

 

 

 

Liver Disorder: Any Liver Disease

Intervention: N/A

Participation: 1 visit

Patient Population: Any supsected or confirmed liver injury/disease

Regina Weber

Phone: (317) 278-3584

Email:Reginaw@iu.edu

 

 

Dr. Raj Vuppalanchi

 

Fibroscan with CAP

 

 

 

Liver Disorder: Non-alcoholic fatty liver disease

Intervention: N/A

Participation: 1 visit

Patient Population: Non-alcoholic fatty liver disease or suspoect Non-alcoholic fatty liver disease

Regina Weber

Phone: (317) 278-3584

Email:Reginaw@iu.edu

 

 

Dr. Raj Vuppalanchi

 

Liver Biopsy Collection 

 

 

 

Liver Disorder: Other

Intervention: N/A

Participation: 1 visit

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

Breann McGee

Phone: (317) 278-9291

Email:Mcgeebr@iu.edu

 

 

Dr. Naga Chalasani

 

PROGRESS

 

 

 

Liver Disorder: Primary Sclerosing Cholangitis

Intervention: N/A

Participation: 1 visit

Patient Population:Patients with primary sclerosing cholangitis with ERCP, MRCP or Liver biopsy

Breann McGee

Phone: (317) 278-9291

Email:Mcgeebr@iu.edu

 

 

Dr. Craig Lammert

 

NAFLD Adult Database 2

 

 

 

Liver Disorder: NAFLD to NASH Cirrhosis 

Intervention: N/A

Participation: 1 visit

Patient Population:Patients with primary sclerosing cholangitis with ERCP, MRCP or Liver biopsy

Breann McGee

Phone: (317) 278-9291

Email:Mcgeebr@iu.edu

 

 

Dr. Craig Lammert

 

Hepatitis E Study

 

 

 

 

Liver Disorder: Hepatitis E

Intervention: N/A

Participation: 1 visit

Patient Population:Pre/post transplant patients

 

Bri Melvin

Phone: (317) 278-9246

Email: Bhartlep@iu.edu

 

 

Dr. Niha Samala

Amiodarone Study

 

 

Liver Disorder: Any liver disease

Intervention: N/A

Participation: 1 visit

Patient Population:Cardiac patients using amiodarone

Regina Weber

Phone: (317) 278-3584

Email:Reginaw@iu.edu

 

Dr. Raj Vuppalanchi