Northwestern University Feinberg School of Medicine
Department of Medicine
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Gastroenterology and Hepatology Clinical Trials

The following searchable list includes all the Division of Gastroenterology and Hepatology, Department of Medicine clinical trials currently looking for participants. 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
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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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Thakrar, Anjali 312 503 1120
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A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (LEGACY)

A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (LEGACY)

Hanauer, StephenHanauer, Stephen
  • Map it 201 E. Huron St.
    Chicago, IL
NCT01848561 STU00094204
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Arrieta, Rose +1 312 695 5878
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A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration

A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration

Hanauer, StephenHanauer, Stephen
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02065570 STU00096539
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Arrieta, Rose +1 312 695 5878
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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)
Carlson, DustinCarlson, Dustin
  • Map it 633 N. St. Clair St.
    Chicago, IL
STU00096856
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Thakrar, Anjali 312 503 1120
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(xIRB) An Open-Label, Multicenter Study to Evaluate Long-term Outcomes with ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ II)
The purpose of this study is to evaluate L…
The purpose of this study is to evaluate Long-term Outcomes following treatment with ABT-450/r/ABT-267, ABT-333 with or without RBV in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Flamm, Steven LFlamm, Steven L
NCT02167945 STU00102262
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1-855-NU-STUDY
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A Phase 3b, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cirrhosis
Primary Biliary Cirrhosis (PBC) is a serious, life--threatening, bile acid related liver disease o…
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
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An Open Label Extension And Safety Monitoring Study Of Moderate To Severe Ulcerative Colitis Patients Previously Enrolled In Etrolizumab Phase II/III Studies

An Open Label Extension And Safety Monitoring Study Of Moderate To Severe Ulcerative Colitis Patients Previously Enrolled In Etrolizumab Phase II/III Studies

Hanauer, StephenHanauer, Stephen
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02118584 STU00200583
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Arrieta, Rose +1 312 695 5878
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A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety Of Etrolizumab As An Induction And Maintenance Treatment For Patients With Moderately To Severely Active Crohn’s Disease (Protocol GA29144)

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety Of Etrolizumab As An Induction And Maintenance Treatment For Patients With Moderately To Severely Active Crohn’s Disease (Protocol GA29144)

Hanauer, StephenHanauer, Stephen
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02394028 STU00201257
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Arrieta, Rose +1 312 695 5878
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An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn’s Disease Previously Enrolled In The Etrolizumab Phase III Protocol GA29144 (Protocol GA29145)

An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn’s Disease Previously Enrolled In The Etrolizumab Phase III Protocol GA29144 (Protocol GA29145)

Hanauer, StephenHanauer, Stephen
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02403323 STU00201259
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Arrieta, Rose +1 312 695 5878
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Phase III, Double Blind, Placebo Controlled, Multicenter Study Of The Efficacy And Safety Of Etrolizumab During Induction And Maintenance In Patients With Moderate To Severe Active Ulcerative Colitis Who Are Refractory To Or Intolerant Of Tnf Inhibitors (Protocol GA28950)

Phase III, Double Blind, Placebo Controlled, Multicenter Study Of The Efficacy And Safety Of Etrolizumab During Induction And Maintenance In Patients With Moderate To Severe Active Ulcerative Colitis Who Are Refractory To Or Intolerant Of Tnf Inhibitors (Protocol GA28950)

Hanauer, StephenHanauer, Stephen
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02100696 STU00200704
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Arrieta, Rose +1 312 695 5878
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A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis
The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo …
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
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A Phase 2, Pilot Study of JKB-122 to Assess Liver Tests (ALT) in Autoimmune Hepatitis Patients Who Are Refractory or Intolerant to Current Therapies
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 ha…
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
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Semen quality in males with inflammatory bowel disease: Influence of methotrexate, ustekinumab and tofacitinib treatment.

Semen quality in males with in…

Semen quality in males with inflammatory bowel disease: Influence of methotrexate, ustekinumab and tofacitinib treatment.

Hanauer, StephenHanauer, Stephen
  • Map it 201 E. Huron St.
    Chicago, IL
STU00201469
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Arrieta, Rose 312 695 5878
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(CIRB) A Multi-Center, Randomized, Placebo-Controlled, Double-Blind Study To Confirm Efficacy And Safety Of Terlipressin In Subjects With Hepatorenal Syndrome Type 1 (The Confirm Study)
This study is to confirm the efficacy and safety of intravenous terlipressin versus placebo in…
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
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An Open-Label, Multicenter and Open Enrollment Model, Postmarketing, Milk-Only Lactation Study to Assess Concentration of Vedolizumab in Breast Milk of Lactating Women With Active Ulcerative Colitis or Crohn’s Disease Who Are Receiving Vedolizumab Therapeutically

An Open-Label, Multicenter and Open Enrollment Model, Postmarketing, Milk-Only Lactation Study to Assess Concentration of Vedolizumab in Breast Milk of Lactating Women With Active Ulcerative Colitis or Crohn’s Disease Who Are Receiving Vedolizumab Therapeutically

Stein, AdamStein, Adam
NCT02559713 STU00202916
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Arrieta, Rose 312 695 5878
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(CIRB) A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Subjects with Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis
treatment for HCV using FDA approved drugs
Hepatitis C, Child pugh C
Flamm, Steven LFlamm, Steven L
  • Map it 675 N. St. Clair St.
    Chicago, IL
NCT02994056 STU00204620
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Hepatitis C

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Gottstein, Jeanne H 312 694 0264
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(CIRB) A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH)
The primary objective of this study is:  To evaluate whether selonsertib (SEL, previously known …
The primary objective of this study is:  To evaluate whether selonsertib (SEL, previously known as GS-4997) can cause fibrosis regression and reduce associated complications in subjects with cirrhosis due to NASH. The secondary objective of this study is:  To assess the safety and tolerability of SEL in subjects with NASH and cirrhosis
Subjects must meet all of the following inclusion criteria to be eligible for participation in this
study.
1) Willing and able to give informed consent prior to any study specific procedures being
performed
2) Liver biopsy consistent with NASH (defined as the presence of at least grade 1 steatosis,
hepatocellular ballooning, and lobular inflammation according to the NAFLD Activity Score
[NAS]) and cirrhosis (F4 fibrosis) according to the NASH CRN classification, in the opinion
of the central reader.
a) A historical liver biopsy within 12 months of the Screening visit may be accepted as the
Screening biopsy if the sample is deemed acceptable for interpretation by the central
reader.
b) If the subject is deemed ineligible for this study, the liver biopsy, if performed according
to protocol specifications and is within 6 months of the Screening visit, may be used to
determine eligibility for study GS-US-384-1943.
3) Subject has the following laboratory parameters at the Screening visit, as determined by the
central laboratory:
a) ALT ≤ 8 x ULN
b) CLcr ≥ 30 mL/min, as calculated by the Cockcroft-Gault equation
c) HbA1c ≤ 9.5%
4) Body Mass Index (BMI) ≥ 18 kg/m2 at Screening
5) Males and non-pregnant, non-lactating females between 18-70 years of age; inclusive based
on the date of the Screening visit
6) Females of childbearing potential (as defined in Appendix 3) must have a negative pregnancy
test at Screening and Day 1
7) Male subjects and female subjects of childbearing potential who engage in heterosexual
intercourse must agree to use protocol specified method(s) of contraception as described in
Appendix 3.
Rinella, Mary EugeniaRinella, Mary Eugenia
NCT03053063 STU00204671
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Sipich, Kimberly A 312 694 1293
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(CIRB) A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
The primary objective of this study is:  To evaluate whether selonsertib (SEL, previously known as…
The primary objective of this study is:  To evaluate whether selonsertib (SEL, previously known as GS- 4997) can cause fibrosis regression and reduce progression to cirrhosis and associated complications in subjects with NASH and bridging (F3) fibrosis. The secondary objective of this study is:  To assess the safety and tolerability of SEL in subjects with NASH and bridging (F3) fibrosis.
1) Liver biopsy consistent with NASH (defined as the presence of at
least grade 1 steatosis, hepatocellular ballooning, and lobular
inflammation according to the NAFLD Activity Score [NAS]) and
bridging (F3 fibrosis) according to the NASH CRN classification, in
the opinion of the central reader.
a) A historical liver biopsy within 6 months of the Screening visit
may be accepted as the Screening biopsy if the sample is deemed
acceptable for interpretation by the central reader.
b) If the subject is deemed ineligible for this study, the liver biopsy,
if performed according to protocol specifications and is within
12 months of the Screening visit, may be used to determine
eligibility for study GS-US-384-1944
2) Subject has the following laboratory parameters at the Screening
visit, as determined by the central laboratory:
a) Alanine aminotransferase (ALT) ≤ 8 x ULN
b) Creatinine Clearance (CLcr) ≥ 30 milliliter/minute (mL/min), as
calculated by the Cockcroft-Gault equation
c) HbA1c ≤ 9.5%
d) Total bilirubin ≤ 1.5 x ULN
Rinella, Mary EugeniaRinella, Mary Eugenia
NCT03053050 STU00204672
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Sipich, Kimberly A 312 694 1293
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NCI 2015-06-03 Statin Therapy to Reduce Disease Progression from Liver Cirrhosis to Cancer
The purpose of this study is to compare the safety and effects of simvastatin in people with liver cirrhosis who are at an increased risk for liver cancer. In this study, you will get either simvastatin 40 mg d…
The purpose of this study is to compare the safety and effects of simvastatin in people with liver cirrhosis who are at an increased risk for liver cancer. In this study, you will get either simvastatin 40 mg daily or placebo daily, a pill that looks like simvastatin 40 mg but contains no medication. Simvastatin is approved by the U.S. Food and Drug Administration (FDA) to reduce the risk for heart attack, stroke, and chest pain in patients who have heart disease or risk factors for heart disease such as smoking, high blood pressure, low high-density lipoprotein (HDL), or family history of early heart disease. It is also approved to lower the risk for heart attack or stroke in patients with type 2 diabetes and risk factors such as diabetic eye or kidney problems, smoking, or high blood pressure. However, simvastatin is not approved by the FDA to decrease the risk of liver cancer. Simvastatin is considered “investigational” (a study drug) in this study. Studies show that simvastatin lowers the risk of heart disease not only by decreasing cholesterol, but also by decreasing inflammation. We believe that this anti-inflammatory effect of simvastatin may help patients with liver cirrhosis.
Confirmed diagnosis of liver cirrhosis assessed by the presence of clinical signs, symptoms, body imaging (ultrasound, computed tomography [CT], or magnetic resonance imaging [MRI]), or liver biopsy
Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
Leukocytes >= 2,500/microliter
Absolute neutrophil count >= 1,500/microliter
Platelets >= 50,000/microliter
Hemoglobin >= 10 g/dL
Total bilirubin =< 3 x institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 5 x institutional ULN
Creatinine =< 1.5 x institutional ULN
Women who are able to become pregnant must have a confirmed negative pregnancy test result prior to enrollment; women >= 50 years of age who have not had a menstrual period in the past year; and women who have had a hysterectomy, both ovaries removed, or a tubal ligation; will not be required to have a pregnancy test
Women who are able to become pregnant must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
Ability to understand and the willingness to sign a written informed consent document and medical release
Willing and able to comply with trial protocol and follow-up
Have had an abdominal imaging test (CT, MRI, or ultrasound) within the past 7 months
Kulik, Laura MKulik, Laura M
  • Map it 675 N. St. Clair St.
    Chicago, IL
NCT02968810 STU00204992
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Sipich, Kimberly A 312 694 1293
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Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease

Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease

Hanauer, StephenHanauer, Stephen
NCT02914561 STU00205056
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Arrieta, Rose 312 695 5878
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