Northwestern University Feinberg School of Medicine

Department of Medicine

Clinical Trials

As part of an academic medical center, the Division of Gastroenterology and Hepatology within the Department of Medicine at Northwestern University Feinberg School of Medicine (Feinberg) aims to improve the human health through scientific research.

About Clinical Trials
Clinical trials test or study drugs, surgical procedures, medical devices, or interventions with human subjects. They look to determine their safety and effectiveness in relation to treating specific diseases. Clinical trials are part of clinical research and are at the heart of all medical advances.

Division of Gastroenterology and Hepatology - Department of Medicine
The following searchable list includes all the Division of Gastroenterology and Hepatology - Department of Medicine clinical trials currently looking for participants.

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Please feel free to contact us with inquiries about any of our ongoing research.

Trials
A Multicenter Group to Study Acute Liver Failure. Long-term Outcomes of Acute Liver Failure Study Group Patients
Data Registry study for acute liver failure.
18-70 yr old adults. Acute Liver Failure (ALF) - INR > 1.5 and hepatic encephalopathy. Acute Liver Injury (ALI) - INR > 2, ALT > 10 x ULN
Ganger, Daniel RGanger, Daniel R
  • Map it 201 E. Huron St.
    Chicago, IL
NCT00518440 STU00016475
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Gottstein, Jeanne H 312 694 0264
Alterations in Gene Expression in the Scleroderma Esophagus
The purpose of this study is to learn more about how Scleroderma (SSc) affects the esophagus to cause symptoms such as heartburn and trouble swallowing (dysphagia). We also want to learn whether the problems that cause esophageal symptoms ar…
The purpose of this study is to learn more about how Scleroderma (SSc) affects the esophagus to cause symptoms such as heartburn and trouble swallowing (dysphagia). We also want to learn whether the problems that cause esophageal symptoms are the same as the problems that cause SSc skin tightening and lung disease. We will collect skin, esophageal and stomach biopsies (small pieces of tissue) to be used for several studies.
Must not be:
- Pregnant or nursing (hormones associated with pregnancy and lactation are known to affect esophageal function)
- Obese (i.e. BMI ≥30)
- Known medical illnesses that could affect esophageal function, gene expression or histology (achalasia, esophageal stricture, esophageal cancer)
- Have a history of alcohol abuse or addiction or score of 2 or higher on the CAGE questionnaire
- Allergies to Fentanyl or Midolazam (sedatives used during endoscopy)
- Allergies to Lidocaine
Hinchcliff, Monique EHinchcliff, Monique E
  • Map it 633 N. St. Clair St.
    Chicago, IL
STU00021381
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Hoffmann, Aileen 312 503 4083
Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)
The purpose of this study is to determine whether ornithine phenylacetate can speed recovery from an acute hepatic encephalopathy episode requiring hospita…
The purpose of this study is to determine whether ornithine phenylacetate can speed recovery from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic patients.
Ganger, Daniel RGanger, Daniel R
  • Map it 201 E. Huron St.
    Chicago, IL
NCT01966419 STU00085977
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Gottstein, Jeanne H 312 694 0264
Healthy Control Esophageal Registry and Biorepository
This study is being done to compare how the esophagus and upper stomach work in people who have Scleroderma with symptoms of reflux disease or difficulty swallowing (dysphagia) to healthy controls. We will collect skin, esophageal and stomach biop…
This study is being done to compare how the esophagus and upper stomach work in people who have Scleroderma with symptoms of reflux disease or difficulty swallowing (dysphagia) to healthy controls. We will collect skin, esophageal and stomach biopsies (small pieces of tissue) to be used for several studies.
Must not be:
- Obese (i.e. BMI ≥30)
- Known medical illnesses that could affect esophageal function, gene expression or histology
- Have a diagnosis of an eating disorder
- Have a diagnosis of an autoimmune disease
- A current or previous smoker (smoked >100 cigarettes in lifetime)
- Have a history of alcohol abuse or addiction or score of 2 or higher on the CAGE questionnaire
- Taking antacids and/or proton pump inhibitors for heartburn
- Allergies to Fentanyl or Midolazam (sedatives used during endoscopy)
- Allergies to Lidocaine (Lidocaine anesthetic jelly used during manometry).
- Pregnant or nursing (hormones associated with pregnancy and lactation are known to affect esophageal function)
Hirano, IkuoHirano, Ikuo
  • Map it 633 N. St. Clair St.
    Chicago, IL
STU00096856
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Hoffmann, Aileen 312 503 4083
Phase 3 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cirrhosis
Primary Biliary Cirrhosis (PBC) is a serious, life--threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibros…
Primary Biliary Cirrhosis (PBC) is a serious, life--threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver transplantation or resulting in death. The investigational drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist that is derived from the primary human bile acid chenodeoxycholic acid. The key mechanisms of action of OCA, including its choleretic, anti-inflammatory, and anti-fibrotic properties, underlie its hepatoprotective effects and result in attenuation of injury and improved liver function in a cholestatic liver disease such as PBC. The study will assess the effect of OCA compared to placebo, combined with stable standard care, on clinical outcomes in PBC patients.
Flamm, Steven LFlamm, Steven L
NCT02308111 STU00200837
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Gottstein, Jeanne H 312 694 0264
A Study of the Efficacy and Safety of Etrolizumab in Ulcerative Colitis Patients Who Are Refractory to or Intolerant of TNF Inhibitors
This phase III, double blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and …
This phase III, double blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission in patients with moderately to severely active ulcerative colitis (UC) who are refractory to or intolerant of tumor necrosis factor (TNF) inhibitors.
Hanauer, StephenHanauer, Stephen
NCT02100696 STU00200704
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1-855-NU-STUDY
JKB-121 for the Treatment of Nonalcoholic Steatohepatitis
To evaluate the safety and potential efficacy of two dose levels of JKB-121 (5 mg twice daily and 10 mg twice daily) in reducing liver fat and/or liver biochemistry compared to placebo in patients with biopsy-proven nonalcoholic steatohepatiti…
To evaluate the safety and potential efficacy of two dose levels of JKB-121 (5 mg twice daily and 10 mg twice daily) in reducing liver fat and/or liver biochemistry compared to placebo in patients with biopsy-proven nonalcoholic steatohepatitis
Rinella, Mary EugeniaRinella, Mary Eugenia
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02442687 STU00201231
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Milosevic, Stanislava 312 694 0326
Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment
The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patient…
The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.
Rinella, Mary EugeniaRinella, Mary Eugenia
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02548351 STU00201580
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Milosevic, Stanislava 312 694 0326
A Phase ll Study of IMM-124E for Patients With Non-alcoholic Steatohepatitis
This study will evaluate the safety and preliminary efficacy of two dose levels of IMM-124E in reducing liver fat and/or serum alanine aminotransaminase (ALT) compared with placebo.
Rinella, Mary EugeniaRinella, Mary Eugenia
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02316717 STU00201957
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Milosevic, Stanislava 312 694 0326
Liver Test Study of Using JKB-122 in AIH Patients
This is a Phase 2, pilot study in which JKB-122 is given once daily for 24 weeks in subjects with autoimmune hepatitis (AIH) who have liver enzymes that are 2 to 10 times the upper limit of normal (ULN) and who have had a f…
This is a Phase 2, pilot study in which JKB-122 is given once daily for 24 weeks in subjects with autoimmune hepatitis (AIH) who have liver enzymes that are 2 to 10 times the upper limit of normal (ULN) and who have had a failed response to, incomplete response to, intolerant to, ineligible to, or unwilling to take current immunosuppressant therapies. The dose of JKB-122 will be escalated monthly.
Flamm, Steven LFlamm, Steven L
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02556372 STU00202224
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Sipich, Kimberly A 312 694 1293
Rapidity of Response to Adalimumab Treatment in Patients With Crohn´s Disease
Rapidity of response to treatments in inflammatory bowel diseases is now considered a field of major interest, due to the importance of achieving the highest benefit in the shortest possible tim…
Rapidity of response to treatments in inflammatory bowel diseases is now considered a field of major interest, due to the importance of achieving the highest benefit in the shortest possible time, in order to favor a fast backward step to normal life. There are no previous studies specifically designed to evaluate the rapidity of response to adalimumab therapy in patients with active Crohn's disease. Studies on rapidity of onset of response to adalimumab have, on the other hand, been performed in other diseases such as rheumatoid arthritis (Efficacy of HUMIRA in Subjects With Active Rheumatoid Arthritis HERO study, Wolfe et al, 2006). This trial will assess the clinical responses occurring earlier than in week 1. This is an open label, one arm, prospective, multicenter, phase IV clinical trial.
Hanauer, StephenHanauer, Stephen
STU00201469
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1-855-NU-STUDY
A Phase 2b, Open-Label Study of 200 mg or 400 mg Sofosbuvir+RBV for 24 Weeks in Genotype 1 or 3 and Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) Tablet for 12 weeks in Genotype 1 or 4 HCV-Infected Subjects with Renal Insufficiency
To evaluate the safety of Ledipasvir/Sofosbuvir (Harvo…
To evaluate the safety of Ledipasvir/Sofosbuvir (Harvoni) for 12 weeks in patients with renal insufficiency, not yet on dialysis
Flamm, Steven LFlamm, Steven L
  • Map it 201 E. Huron St.
    Chicago, IL
NCT01958281 STU00202407
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Sipich, Kimberly A 312 694 1293
A Study To Confirm Efficacy and Safety of Terlipressin in HRS Type 1
This study is to confirm the efficacy and safety of intravenous terlipressin versus placebo in the treatment of adult subjects with hepatorenal syndrome (HRS) Type 1.
Ganger, Daniel RGanger, Daniel R
NCT02770716 STU00203053
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Gottstein, Jeanne H 312 694 0264
(CIRB) A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-0976 in Subjects with Nonalcoholic Steatohepatitis
This study will test an experimental drug GS-0976 for the treatment of Nonalcoholic Steatohepatitis (NASH). NASH is an aggres…
This study will test an experimental drug GS-0976 for the treatment of Nonalcoholic Steatohepatitis (NASH). NASH is an aggressive form of Nonalcoholic Fatty Liver Disease (NAFLD) in which the liver becomes fatty, inflamed and liver cells become injured. Scarring of the liver (fibrosis) may also occur.
Rinella, Mary EugeniaRinella, Mary Eugenia
  • Map it 633 N. St. Clair St.
    Chicago, IL
NCT02856555 STU00203619
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Sipich, Kimberly A 312 694 1293
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects with Nonalcoholic Steatohepatitis (NASH)
A study to evaluate the safety and tolerability of GS-9674 in subjects with NASH
Clinical diagnosis of non-alcoholic fatty liver disease (NAFLD) with histological or imaging evidence of fatty liver within the past 2 years.Screening MRI-PDFF with >= 10 % steatosis, screening MRE with liver stiffness >= 2.9 kPa; Platelet count >=150,000/mm3; Albumin >= 3.3 g/dL; Exclusions include: ALT > 5x ULN, other causes of liver disease including autoimmune, viral and alcoholic liver disease, liver cirrhosis.
Rinella, Mary EugeniaRinella, Mary Eugenia
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02854605 STU00204121
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NASH

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Khan, Noreen Osman 312 694 1295