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 (PI)

Intercept 302 PBC Study

Clinicaltrials.gov Identifier: NCT02308111

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

Clinicaltrials.gov Identifier: NCT02943460

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

Clinicaltrials.gov Identifier: NCT02548351 

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

Clinicaltrials.gov Identifier: NCT03112681 

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: Intercept Moderately Severe Alcoholic Hepatitis

Clinicaltrials.gov Identifier: NCT02039219

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: Immuron Severe Alcoholic Hepatitis

Clinicaltrials.gov Identifier: NCT01968382

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: Effect of Heavy Alcohol Consumption on Farnesoid X Receptor (FXR) Signaling

Clinicaltrials.gov Identifier: NCT02654236

Liver Disorder: Other

Intervention: Obeticholic Acid tablet or PlaceboParticipation:  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: Effect of Heavy Alcohol Consumption on Farnesoid X Receptor (FXR) Signaling

Clinicaltrials.gov Identifier: NCT02655510

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

Clinicaltrials.gov Identifier: TBD

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

 

 

LIVER RESEARCH: OBSERVATIONAL/DATABASE STUDIES

Study Title

Study Information

Coordinator to Contact

Principle Investigator (PI)

PBC Database

Clinicaltrials.gov Identifier: N/A

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

Clinicaltrials.gov Identifier: N/A

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

Clinicaltrials.gov Identifier: N/A

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 Database 

Clinicaltrials.gov Identifier: N/A

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

Clinicaltrials.gov Identifier: N/A

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

Clinicaltrials.gov Identifier: N/A

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 

Clinicaltrials.gov Identifier: N/A

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

Clinicaltrials.gov Identifier: N/A

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 

Clinicaltrials.gov Identifier: NCT00345930

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 

Clinicaltrials.gov Identifier: NCT00345930

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 

Clinicaltrials.gov Identifier: NCT00360646

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:  Alcohol Hepatitis Observational Study

Clinicaltrials.gov Identifier: NCT02172898

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. Suthat Liangpunsakul

Midwest Cirrhosis Consortium

Clinicaltrials.gov Identifier: N/A

Liver Disorder: Cirrhosis

Intervention:

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

Clinicaltrials.gov Identifier: N/A

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

Clinicaltrials.gov Identifier: N/A

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 for Future Research

Clinicaltrials.gov Identifier: N/A

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

Clinicaltrials.gov Identifier: N/A

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

Clinicaltrials.gov Identifier: N/A

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

Clinicaltrials.gov Identifier: N/A

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

Clinicaltrials.gov Identifier: N/A

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