SCHOOL OF MEDICINE

Department of Medicine

Gastroenterology Hepatology

Liver Research

CLINICAL TRIALS 

  • Alcoholic Hepatitis (AH)
  • Autoimmune Hepatitis (AIH)
  • Cirrhosis
  • Drug Induced Liver Injury (DILI)
  • Hepatic Adenoma 
  • Hepatitis E
  • Hepatocellular Carcinoma
  • Non-Alcoholic Fatty Liver Disease (NAFLD/NASH)
  • Primary Biliary Cholangitis (PBC)
  • Primary Sclerosing Cholangitis (PSC)
  • Other

DRUG CLINICAL TRIALS - OPEN TO ENROLLMENT

Liver Disease

Study Title

Study Information

Coordinator to Contact

Principal Investigator 

Cirrhosis

 

 

 

 

 

 

 

SYNLOGIC

 

 

 

 

 

 

 

Liver Disorder: Cirrhosis from any cause

Intervention:12 day Inpatient study to assess the safety and tolerability of study drug in  patients with hepatic insufficiency and hyperammonemia.

Participation:  12 Inpatient study days, up to 2 weeks of outpatient monitoring

Patient Population: Adults with cirrhosis and hyperammoniaemia

Enrolling Period: April 2018 - May 2022

 

Charlene Jones, RN

Phone: (317) 278-9215

Email:Jones572@iu.edu

 

 

Dr. Marwan Ghabril

 

 

NASH/NAFLD

 

 

 

 

 

 

 

CONATUS - 17

 

 

 

 

 

 

 

Liver Disorder: NASH Cirrhosis

Intervention:Emricasan
25 mg BID,  5 mg BID, or matching placebo BID to seek to decrease portal hypertension

Participation:  at least 54 weeks

Patient Population: Adults with Decompensated NASH Cirrhosis and history of either Ascites or bleeding esophogeal varices. Meld 10-18

Enrolling Period: March 2018 - June 2019

 

Charlene Jones, RN

Phone: (317) 278-9215

Email:Jones572@iu.edu

 

 

Dr. Marwan Ghabril

 

 

 

 

 

 

 

 

 

 

INTERCEPT - 303 NASH

 

 

 

 

 

 

 

Liver Disorder: NASH

Intervention: Obeticholic Acid tablet or Placebo

Participation: Up to 6 years

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

Enrolling Period: 2015 - 2022

 

 

 

Rachel Lee, RN

Phone: (317) 278-6266

Email: Lee352@iu.edu     

 

 

Dr. Raj Vuppalanchi

 

 

 

 

 

 

 

 

 

 

 

CIRIUS - NASH

 

 

 

 

 

 

 

Liver Disorder:  NASH

Intervention:MSDC-0602K or Placebo

Participation:  Adults with NASH F1-F3 fibrosis with biopsy proven NASH within 9 months

Patient Population: 1 year 

Enrolling Period: April 2017 - May 2019

 

 

 

Wendy Morlan, RN

 Phone: (317) 278-9355

 Email:Wmorlan@iu.edu

 

 

Dr. Samer Gawrieh

 

 

 

 

 

 

 

 

 

 

 

ZYDUS - NASH

 

 

 

 

 

 

 

Liver Disorder: NAFLD/NASH

Intervention: Saroglitazar Magnesium or Placebo

Participation:  16 week

Patient Population: Adults with NAFLD/NASH confirmed with imaging or biopsy within 1 year, Elevated ALT levels.

Enrolling Period: June 2017 - 2030

 

 

 

Wendy Morlan, RN

 Phone: (317) 278-9355

 Email:Wmorlan@iu.edu

 

 

Dr. Samer Gawrieh

 

 

 

Primary Biliary Cholangitis (PBC)

 

 

 

 

 

 

 

INTERCEPT - 302 PBC 

 

 

 

 

 

 

 

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

Enrolling Period:  2014 - 2024

 

 

 

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. 

Enrolling Period:  2017 - March 2019

 

Rachel Lee, RN

Phone: (317) 278-6266

Email: Lee352@iu.edu

 

 

Dr. Raj Vuppalanchi

\

 

 

Other

 

 

 

 

 

 

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 alcohol drinkers without liver disease

Enrolling Period: 2014 - December 2018

 

Jennifer Lehman, RN

Phone: (317) 278-1872

Email: Jgeck@iu.edu

 

Dr. Suthat Liangpunsakul

 

 

 

 

 

 

 

 

ECT

 

 

 

 

 

 

Liver Disorder: TBD

Intervention: TBD

Participation:  TBD

Patient Population: TBD

Enrolling Period: May 2018 - 2022

 

 

Dawn Rank, RN

 Phone: (317) 278-6222

 Email:drank@iu.edu

 

Dr. Naga Chalasani

 

 


DRUG CLINICAL TRIALS - CLOSED TO ENROLLMENT

 

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

Enrolling Period: Closed

 

 

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

Enrolling Period: Closed

 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

Enrolling Period: Closed

 

 

Jennifer Lehman, RN

Phone: (317) 278-1872

Email: Jgeck@iu.edu

 

 

Dr. Raj Vuppalanchi

 

 

 

 

JKB - 122

 

 

 

 

 

 

 

Liver Disorder: Autoimmune Hepatitis 

Intervention: Naltrexone (NARCAN)

Participation:  7 months

Patient Population: Adults with AIH who have had a failed or imcomplete response to current immunosuppresant therapies 

Enrolling Period: Closed

 

 

Regina Weber, RT

Phone: (317) 278-3584

Email:Reginaw@iu.edu

 

 

Dr. Craig Lammert

 

 

 

 

CONATUS - 14

 

 

 

 

 

 

 

Liver Disorder: NASH Cirrhosis

Intervention:emricasan
50 mg BID, emricasan 25 mg BID, emricasan 5 mg BID, or matching placebo BID

Participation:  1 year

Patient Population: Adults with compensated or mildly decompensated NASH Cirrhosis, CPT-A or B, Meld < 10.

Enrolling Period: Closed

 

 

Charlene Jones, RN

Phone: (317) 278-9215

Email:Jones572@iu.edu


 

 

Dr. Marwan Ghabril

 

 

 

 

 

 

 

 

 

 

 

CUMBERLAND

 

 

 

 

 

 

 

Liver Disorder: NAFLD/NASH

Intervention: Ifetroban or placebo IV dosing at randomizaton followed by oral capsules for duration of study

Participation: 90 days

Patient Population: Adults with cirrhosis and hvpg >8 or <18

Enrolling Period: Closed

 

 

Nina Garrett, RN

 Phone: (317) 278-9245

 Email:Ninagarr@iu.edu

 

 

Dr. Eric Orman

 

 

 

 

 

 

 

 

 

 

STELLAR - 3

 

 

 

 

 

 

 

Liver Disorder: NASH with Stage 3 Fibrosis

Intervention: Selonsertib (6mg or 18mg) or Placebo

Participation:  240 weeks

Patient Population: Adults with NASH and biopsy proven F3 fibrosis of the liver

Enrolling Period: Closed

 

 

 

Mandy Cruz, RN

 Phone: (317) 278-6215

 Email:mandcruz@iu.edu

 

 

Dr. Raj Vuppalanchi

 

 

 

 

 

 

 

 

 

 

 

STELLAR - 4

 

 

 

 

 

 

 

Liver Disorder: NASH Cirrhosis

Intervention: Selonsertib (6mg or 18mg) or Placebo

Participation:  240 weeks

Patient Population: Adults with NASH and biopsy proven cirrhosis of the liver; cannot have history of decompensated cirrhosis

Enrolling Period: Closed

 

 

Mandy Cruz, RN

 Phone: (317) 278-6215

 Email:mandcruz@iu.edu

 

 

Dr. Raj Vuppalanchi

 

 

 

 


OBSERVATIONAL & DATABASE TRIALS

Liver Disease

Study Title

Study Information

Coordinator to Contact

Principle Investigator 

Alcoholic Hepatitis

 

 

 

 

 

 

 

TREAT 001

 

 

 

 

 

 

 

Liver Disorder: Alcoholic Hepatitis

 Intervention: None

 Participation:  1 visit

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

Enrolling: Closed

 

 

 

 Savannah Musselman, BS

 Phone: (317) 278-6424

 Email: samussel@iu.edu

 

 

Dr. Naga Chalasani

 

 

 

 

Autoimmune Hepatitis (AIH)

 

 

 

 

 

GRACE: Autoimmune Hepatitis Database

 

 

 

 

 

Liver Disorder: Autoimmune Hepatitis

 Intervention: None

 Participation:  1 visit

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

Enrolling: Yes

 

Katie Nordin, BS

Email: kanordin@iu.edu

 

 

Dr. Craig Lammert

 

 

 

Cirrhosis

 

 

 

 

 

 

ALC Database 

 

 

 

 

 

 

 Liver Disorder: Cirrhosis

 Intervention: None

 Participation:  1 visit

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

Enrolling: Yes

 

 Katie Nordin, BS

Email: kanordin@iu.edu

 

 

Dr. Suthat Liangpunsakul

 

 

 

 

 

 

 

 

 

Cirrhotic Database

 

 

 

 

 

 

 

Liver Disorder: Cirrhosis

 Intervention: None

 Participation:  1 visit

 Patient Population: Cirrhosis/Only Pre- Transplant

Enrolling: Yes

 

 

 

Katie Nordin, BS

Email: kanordin@iu.edu

 

 

Dr. Suthat Liangpunsakul

 

 

 

 

 

 

 

 

 

 

 

UCD Database

 

 

 

 

 

 

 

 Liver Disorder: Cirrhosis

 Intervention: None

 Participation:  1 visit

 Patient Population: Cirrhosis with and without hepatic  encephalopathy 

Enrolling: Yes

 

 

 

Regina Weber, RT

Phone: (317) 278-3584

Email:Reginaw@iu.edu

 

 

Dr. Marwan Ghabril

 

 

 

 

 

 

 

 

 

 

Midwest Cirrhosis Consortium

 

 

 

 

 

Liver Disorder: Cirrhosis

Intervention: None

Participation:  Multiple visits while inpatient 

Patient Population: Inpatient Cirrhotics

Enrolling: Yes

 

 

Casey Snoddy, BS

Phone: (317) 278-8118

Email: casnoddy@iu.edu

 

Dr. Marwan Ghabril

Dr. Eric Orman

 

 

 

 

 

Drug Induced Liver Injury (DILI)

 

 

 

 

 

 

Prospective DILIN 

 

 

 

 

 

 

 

 Liver Disorder: Drug-induced Liver Injury

 Intervention: None

 Participation:  6-24 months

 Patient Population: DILI within 6 Months of Injury

Enrolling: Yes

 

 

 

 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: None

 Participation:  6-24 months

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

Enrolling: Yes

 

 

 

 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: None

 Participation:  1 visit

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

Enrolling: Yes

 

 

 

Wendy Morlan, RN

 Phone: (317) 278-9355

 Email:Wmorlan@iu.edu

 

 

Dr. Naga Chalasani

Dr. Raj Vuppalanchi

Dr. Marwan Ghabril

 

 

 

 

 

Hepatic Adenoma

 

 

 

 

 

 

Hepatic Adenoma Biorepository

 

 

 

 

 

 Liver Disorder: Other

 Intervention: None

 Participation:  1 visit

 Patient Population: Hepatic adenoma with hx oral  contraceptive use

Enrolling: Yes

 

 

 Katie Nordin, BS

Email: kanordin@iu.edu

 

 

Dr. Craig Lammert

 

 

Hepatitis E

 

 

 

 

 

 

 

Hepatitis E Study

 

 

 

 

 

 

 

Liver Disorder: Hepatitis E

Intervention: None

Participation: 1 visit

Patient Population:Pre/post transplant patients

Enrolling: Yes

 

 

 

Emily Smith, BS

Phone: (317) 274-1692

Email:es37@iu.edu

 

Dr. Niha Samala

 

 

 

Hepatic Adenoma

 

 

 

 

 

 

TARGET - HCC

 

 

 

 

 

 

Liver Disorder: Hepatocellular Carcinoma

Intervention: None

Participation:  1 Visit

Patient Population: Adults with Hepatocellular Carcinoma, viral hepatitis and NAFLD

Enrolling: Yes

 

 

Jeff Gehring, BS

Phone: (317) 278-9207

Email:  jgehrin@iu.edu

 

 

Dr. Naga Chalasani

 

 

 

NASH/NAFLD

 

 

 

 

 

 

NAFLD Database 2

 

 

 

 

 

 

Liver Disorder: NAFLD

Intervention: None

Participation:  4 years

Patient Population: Adult patients with suspected or known non-alcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH)-related cirrhosis of the liver

Enrolling: Yes

 

 

Dawn Rank, RN

 Phone: (317) 278-6222

 Email:drank@iu.edu

 

 

Dr. Naga Chalasani

 

 

 

 

 

 

 

 

 

 

Molecular Stethoscope

 

 

 

 

 

 

Liver Disorder: NAFLD, NASH

 Intervention: None

 Participation:  1 visit

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

Enrolling: Closed

 

 

 Katie Nordin, BS

Email: kanordin@iu.edu

 

 

Dr. Suthat Liangpunsakul

 

 

 

 

 

 

 

 

 

Fibroscan with CAP

 

 

 

 

 

 

 

Liver Disorder: NAFLD

Intervention:None

Participation: 1 visit

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

Enrolling: Yes

 

 

 

Regina Weber, RT

Phone: (317) 278-3584

Email:Reginaw@iu.edu

 

 

Dr. Raj Vuppalanchi

 

 

 

 

 

 

 

 

 

 

NAFLD Adult Database 2

 

 

 

 

 

 

Liver Disorder: NAFLD to NASH Cirrhosis 

Intervention: None

Participation: 1 visit

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

Enrolling: Yes

 

 

Katie Nordin, BS

Email: kanordin@iu.edu

 

 

Dr. Craig Lammert

 

 

 

 

 

 

 

 

 

 

 

Fatty Liver Clinic

 

 

 

 

 

 

 

 

Liver Disorder: NAFLD

Intervention: None

Participation:  1 Visit

Patient Population: Adults with NAFLD

Enrolling: Yes

 

 

 

 

Emily Smith, BS

Phone: (317) 274-1692

Email:es37@iu.edu

 

 

Dr. Niha Samala

 

 

 

 

 

 

 

 

 

 

 

 

 

PRO-121-NAFLD

 

 

 

 

 

 

 

Liver Disorder: NAFLD – NASH F3

Intervention: None

Participation:  1 visit, optional second visit for first         10 patients who accept

Patient Population: Adults age 40-75 who have recent liver biopsies with results in the following cohorts: Absence of NAFL, Early Stage NAFLD, NASH with no fibrosis, NASH with fibrosis stages 1 to 3

Enrolling: Yes

 

 

Emily Smith, BS

Phone: (317) 274-1692

Email:es37@iu.edu

 

 

Dr. Niha Samala

 

 

 

 

 

 

 

 

 

 

 

 

HIV FATTY LIVER

 

 

 

 

 

 

 

Liver Disorder: NAFLD

Intervention: None

Participation:  1 Visit

Patient Population: Adults with HIV and fatty liver

Enrolling: Yes

 

 

 

Montreca Robinson

Phone: (317) 278-3584

Email: mgroiso@iu.edu

 

 

Dr. Samer Gawrieh

 

 

 

 

 

 

 

 

 

 

 

 

HIV NASH

 

 

 

 

 

 

 

Liver Disorder: NASH

Intervention: None

Participation:  1 Visit

Patient Population: Adults with HIV, NASH and hepatic fibrosis

Enrolling: Yes

 

 

 

Montreca Robinson

Phone: (317) 278-3584

Email: mgroiso@iu.edu

 

 

Dr. Samer Gawrieh

 

 

 

 

 

 

 

 

 

 

DIET INTAKE

 

 

 

 

 

 

 

Liver Disorder: NAFLD

Intervention: None

Participation:  1 Visit

Patient Population: Adults with NAFLD

Enrolling: Yes

 

 

 

Regina Weber, RT

Phone: (317) 278-3584

Email:Reginaw@iu.edu

 

 

Dr. Raj Vuppalanchi

 

 

 

Primary Biliary Cholangitis (PBC)

 

 

 

 

 

PBC Itch  

 

 

 

 

 

 

 Liver Disorder: Primary Biliary Cholangitis

 Intervention: None

 Participation:  1 visit

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

Enrolling: Yes

 

 

 Katie Nordin, BS

Email: kanordin@iu.edu

 

 

 Dr. Naga Chalasani

 

 

 

Primary Sclerosing Cholangitis (PSC)

 

 

 

 

 

PROGRESS

 

 

 

 

 

 

Liver Disorder: Primary Sclerosing Cholangitis

Intervention: None

Participation: 1 visit

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

Enrolling: Yes

 

 

Katie Nordin, BS

Email: kanordin@iu.edu

 

 

Dr. Craig Lammert

 

 

Other

 

 

 

 

 

 

 

Fibroscan Database

 

 

 

 

 

 

 

Liver Disorder: Any Liver Disease

Intervention: None

Participation: 1 visit

Patient Population: Any supsected or confirmed liver injury/disease

Enrolling: Yes

 

 

 

Regina Weber, RT

Phone: (317) 278-3584

Email:Reginaw@iu.edu

 

 

Dr. Raj Vuppalanchi

 

 

 

 

 

 

 

 

 

 

Liver Biopsy Collection 

 

 

 

 

 

 

Liver Disorder: Other

Intervention: None

Participation: 1 visit

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

Enrolling: Yes

 

Savannah Musselman, BS

 Phone: (317) 278-6424

 Email: samussel@iu.edu

 

Dr. Naga Chalasani

 

 

 

 

 

 

 

 

 

 

Amiodarone Study

 

 

 

 

 

 

 

Liver Disorder: Any liver disease

Intervention: None

Participation: 1 visit

Patient Population:Cardiac patients using amiodarone

Enrolling: Yes

 

 

 

Regina Weber, RT

Phone: (317) 278-3584

Email:Reginaw@iu.edu

 

 

Dr. Raj Vuppalanchi