Back to resultsSelonsertib in Combination With Prednisolone Versus Prednisolone Alone in Participants With Severe Alcoholic Hepatitis (AH)
Primary Purpose
Alcoholic Hepatitis (AH)
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Selonsertib
Prednisolone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alcoholic Hepatitis (AH) focused on measuring Cirrhosis, Prednisone, Jaundice
Eligibility Criteria
Key Inclusion Criteria:
- Willing and able to give informed consent prior to any study specific procedures being performed. In individuals with hepatic encephalopathy (HE) which may impair decision-making, consent will be obtained per hospital procedures (eg, by Legally Authorized Representative)
Clinical diagnosis of severe AH
- Maddrey's Discriminant Function (DF) ≥ 32 at screening
Key Exclusion Criteria:
- Pregnant or lactating females;
- Other causes of liver disease including chronic hepatitis B (hepatitis B surface antigen [HBsAg] positive), chronic hepatitis C (HCV RNA positive), acetaminophen hepatotoxicity, biliary obstruction, and autoimmune liver disease;
- Serum aspartate aminotransferase (AST) >400 U/L or alanine aminotransferase (ALT) >300 U/L;
- Model for End Stage Liver Disease (MELD) >30 at screening;
- Maddrey's DF >60 at screening;
- Grade 4 Hepatic Encephalopathy (HE) by West Haven criteria;
- Concomitant or previous history of hepatocellular carcinoma;
- History of liver transplantation;
- HIV Ab positive;
- Clinical suspicion of pneumonia;
- Uncontrolled sepsis;
- Uncontrolled gastrointestinal (GI) bleeding or controlled GI bleeding within 7 days of screening that was associated with shock or required transfusion of more than 3 units of blood;
- Type 1 hepatorenal syndrome (HRS) or renal failure defined as a serum creatinine >221 μmol/L (>2.5 mg/dL) or the requirement for renal replacement therapy;
- Individuals dependent on inotropic (eg, epinephrine or norepinephrine) or ventilatory support (ie, endotracheal intubation or positive-pressure ventilation);
- Portal vein thrombosis;
- Acute pancreatitis;
- Cessation of alcohol consumption for more than 2 months before Baseline/ Day 1
Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Sites / Locations
- University of Arkansas for Medical Sciences
- Southern California Research Centers
- Cedars Sinai Medical Center
- Cleveland Clinic Florida
- Oschner Medical Center
- Beth Israel Deaconess Medical Center
- University of Michigan
- University of Pennsylvania
- Methodist Healthcare Dallas - The Liver Institute
- Liver Institute of Virginia
- University of Washington
- Medizinische Universitat Graz
- Universitätsklinik für Innere Medizin I
- Medical University Vienna
- Cliniques Universitaires UCL Saint-Luc
- CUB Hopital Erasme
- Ghent University Hospital
- Universitair Ziekenhuis Leuven
- Centre Hospitalier Universitaire de Liege
- University of Calgary
- University of Manitoba
- Toronto General Hospital
- CHU Amiens Picardie
- CHU Angers
- Hôpital Jean Minjoz
- C.H.U. de Caen
- CHU henri Mondor
- CHU de Grenoble- Hopital Michallon
- CHRU de Lille
- Hôpital de la Croix Rousse
- Hopital La Pitie Salpetriere
- Hopital Paul Brousse
- University of Zurich
- Brighton & Sussex University Hospitals NHS Trust
- Hull and East Yorkshire Hospitals NHS Trust
- Royal Liverpool & Broadgreen University Hospitals NHS Trust
- Barts Health NHS Trust
- Chelsea and Westminster Hospital
- Imperial College
- Kings College Hospital NHS Trust
- Freeman Hospital
- Nottingham University Hospitals NHS Trust
- Derriford Hospital
- Portsmouth Hospitals NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Selonsertib + Prednisolone
Prednisolone
Arm Description
Selonsertib + prednisolone for 28 days
Selonsertib placebo + prednisolone for 28 days
Outcomes
Primary Outcome Measures
Percentage of Participants With Treatment-Emergent (TE) Adverse Events (AE), Serious AEs (SAE), AEs Leading to Premature Study Drug Discontinuation, and Grade 3 or 4 Laboratory Abnormalities
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.
Secondary Outcome Measures
Percentage of Participants Who Died by Day 28
The percentage of participants who died by Day 28 was calculated.
Percentage of Participants Who Died by Week 8
The percentage of participants who died by Week 8 was calculated.
Percentage of Participants Who Died by Week 12
The percentage of participants who died by Week 12 was calculated.
Percentage of Participants Who Died by Week 24
The percentage of participants who died by Week 24 was calculated.
Percentage of Participants With Survival at Day 28 Using Kaplan-Meier
The percentage of participants with survival at Day 28 using Kaplan-Meier was calculated.
Percentage of Participants With Survival at Week 8 Using Kaplan-Meier
The percentage of participants with survival at Week 8 using Kaplan-Meier was calculated.
Percentage of Participants With Survival at Week 12 Using Kaplan-Meier
The percentage of participants with survival at Week 12 using Kaplan-Meier was calculated.
Percentage of Participants With Survival at Week 24 Using Kaplan-Meier
The percentage of participants with survival at Week 24 using Kaplan-Meier was calculated.
Percentage of Participants Who Received a Liver Transplant
The percentage of participants who received a liver transplant by week 24 was calculated.
Percentage of Participants With Hepatorenal Syndrome (HRS)
The occurrence of HRS was confirmed based on the following diagnostic criteria from the International Ascites Club (IAC): 1) Cirrhosis with ascites, 2) Diagnosis of acute kidney injury (AKI) according to the ICA-AKI criteria, 3) Absence of shock, 4) No current or recent treatment with nephrotoxic drugs, and 5) Absence of parenchymal renal disease as indicated by proteinuria >500 mg/day, microhematuria (> 50 red blood cells per high power field) and/or abnormal renal ultrasonography.
Percentage of Participants With Infection
The occurrence of bacterial, fungal, or viral infections was recorded. An infection was considered definite in participants with clinical evidence of infection and a positive culture from a normally sterile source (with the exception of spontaneous bacterial peritonitis).
Length of Hospital Stay
Length of initial hospital stay from first dose date of study drug was calculated for participants who were released from initial hospitalization separately from those who died during their initial hospitalization.
Change From Baseline in Liver Biochemistry Tests: Alanine Aminotransferase (ALT)
Change from Baseline was calculated as the value at endpoint minus the value at Baseline.
Change From Baseline in Liver Biochemistry Tests: Aspartate Aminotransferase (AST)
Change from Baseline was calculated as the value at endpoint minus the value at Baseline.
Change From Baseline in Liver Biochemistry Tests: Gamma Glutamyl Transferase (GGT)
Change from Baseline was calculated as the value at endpoint minus the value at Baseline.
Change From Baseline in Liver Biochemistry Tests: Alkaline Phosphatase
Change from Baseline was calculated as the value at endpoint minus the value at Baseline.
Change From Baseline in Liver Biochemistry Tests: Bilirubin
Change from Baseline was calculated as the value at endpoint minus the value at Baseline.
Change From Baseline in Liver Biochemistry Tests: Albumin
Change from Baseline was calculated as the value at endpoint minus the value at Baseline.
Change From Baseline in Liver Biochemistry Tests: International Normalized Ratio (INR)
Change from Baseline was calculated as the value at endpoint minus the value at Baseline.
Percentage of Participants With Lille Response (Score < 0.45) at Day 7
The Lille score is a tool used to predict which participants with severe alcoholic hepatitis (AH) were not responding to corticosteroid therapy. It ranges between 0 and 1, with low scores (< 0.16) indicating complete response or positive response to steroids (continue therapy) and high scores (≥ 0.56) indicating no response or poor response to steroids (stop therapy). The Lille score was calculated using baseline factors: age, albumin, total bilirubin, serum creatinine, prothrombin time; and the change in total bilirubin between baseline (Day 1) and Day 7. Lille response was defined as having a Lille score < 0.45.
Percentage of Participants With a Lille Null Response (Score ≥ 0.56) at Day 7
The Lille score is a tool used to predict which participants with severe AH were not responding to corticosteroid therapy. It ranges between 0 and 1, with low scores (< 0.16) indicating complete response or positive response to steroids (continue therapy) and high scores (≥ 0.56) indicating no response or poor response to steroids (stop therapy). The Lille score was calculated using baseline factors: age, albumin, total bilirubin, serum creatinine, prothrombin time; and the change in total bilirubin between baseline (Day 1) and Day 7. Lille null response was defined as having a Lille score ≥ 0.56.
Lille Score at Day 7 as a Continuous Variable
The Lille score is a tool used to predict which participants with severe AH were not responding to corticosteroid therapy. It ranges between 0 and 1, with low scores (< 0.16) indicating complete response or positive response to steroids (continue therapy) and high scores (≥ 0.56) indicating no response or poor response to steroids (stop therapy). The Lille score was calculated using baseline factors: age, albumin, total bilirubin, serum creatinine, prothrombin time; and the change in total bilirubin between baseline (Day 1) and Day 7.
Percentage of Participants With Estimated Mortality at Month 2 and Month 6: Combined Scoring Including Lille Score at Day 7 and Baseline Model for End-Stage Liver Disease (MELD) Score
The Lille score is a tool used to predict which participants with severe AH were not responding to corticosteroid therapy. It ranges between 0 and 1, with low scores (< 0.16) indicating complete response or positive response to steroids (continue therapy) and high scores (≥ 0.56) indicating no response or poor response to steroids (stop therapy). MELD scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40, with higher scores indicating greater disease severity. A scoring system combining the Lille score at Day 7 and the baseline MELD score was used to calculate the percentage of participants expected to die by Month 2 and by Month 6.
Change From Baseline in Prognostic Index: Model for End-Stage Liver Disease (MELD) Score
MELD scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40, with higher scores indicating greater disease severity. Change from Baseline was calculated as the value at endpoint minus the value at Baseline.
Change From Baseline in Prognostic Index: Child-Pugh-Turcotte (CPT) Score
CPT scores are used to assess the severity of cirrhosis. Scores can range from 5 to 15, with higher scores indicating a greater severity of disease
Change From Baseline in Prognostic Index: Maddrey Discriminant Function (DF) Score
Baseline Maddrey DF score is a prognostic tool used to determine the next step of treatment based on the severity of AH. Maddrey DF score of < 32 indicates mild to moderate AH and a lower chance of death in the next few months. Maddrey DF score of ≥ 32 indicates severe AH and a higher chance of death in the next few months. The score has no bounds.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02854631
Brief Title
Selonsertib in Combination With Prednisolone Versus Prednisolone Alone in Participants With Severe Alcoholic Hepatitis (AH)
Official Title
A Phase 2, Double-Blind, Randomized Study Evaluating the Safety, Tolerability, and Efficacy of GS-4997 in Combination With Prednisolone Versus Prednisolone Alone in Subjects With Severe Alcoholic Hepatitis (AH)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
February 16, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective of this study is to evaluate the safety and tolerability of selonsertib (GS-4997) in combination with prednisolone versus prednisolone alone in participants with severe alcoholic hepatitis (AH).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholic Hepatitis (AH)
Keywords
Cirrhosis, Prednisone, Jaundice
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Selonsertib + Prednisolone
Arm Type
Experimental
Arm Description
Selonsertib + prednisolone for 28 days
Arm Title
Prednisolone
Arm Type
Placebo Comparator
Arm Description
Selonsertib placebo + prednisolone for 28 days
Intervention Type
Drug
Intervention Name(s)
Selonsertib
Other Intervention Name(s)
GS-4997
Intervention Description
18 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
40 mg (4 x 10 mg tablets) administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Selonsertib placebo tablet administered orally once daily
Primary Outcome Measure Information:
Title
Percentage of Participants With Treatment-Emergent (TE) Adverse Events (AE), Serious AEs (SAE), AEs Leading to Premature Study Drug Discontinuation, and Grade 3 or 4 Laboratory Abnormalities
Description
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.
Time Frame
Up to Day 28 plus 30 days
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Died by Day 28
Description
The percentage of participants who died by Day 28 was calculated.
Time Frame
Day 28
Title
Percentage of Participants Who Died by Week 8
Description
The percentage of participants who died by Week 8 was calculated.
Time Frame
Week 8
Title
Percentage of Participants Who Died by Week 12
Description
The percentage of participants who died by Week 12 was calculated.
Time Frame
Week 12
Title
Percentage of Participants Who Died by Week 24
Description
The percentage of participants who died by Week 24 was calculated.
Time Frame
Week 24
Title
Percentage of Participants With Survival at Day 28 Using Kaplan-Meier
Description
The percentage of participants with survival at Day 28 using Kaplan-Meier was calculated.
Time Frame
Day 28
Title
Percentage of Participants With Survival at Week 8 Using Kaplan-Meier
Description
The percentage of participants with survival at Week 8 using Kaplan-Meier was calculated.
Time Frame
Week 8
Title
Percentage of Participants With Survival at Week 12 Using Kaplan-Meier
Description
The percentage of participants with survival at Week 12 using Kaplan-Meier was calculated.
Time Frame
Week 12
Title
Percentage of Participants With Survival at Week 24 Using Kaplan-Meier
Description
The percentage of participants with survival at Week 24 using Kaplan-Meier was calculated.
Time Frame
Week 24
Title
Percentage of Participants Who Received a Liver Transplant
Description
The percentage of participants who received a liver transplant by week 24 was calculated.
Time Frame
Day 28, Week 8, Week 12, and Week 24
Title
Percentage of Participants With Hepatorenal Syndrome (HRS)
Description
The occurrence of HRS was confirmed based on the following diagnostic criteria from the International Ascites Club (IAC): 1) Cirrhosis with ascites, 2) Diagnosis of acute kidney injury (AKI) according to the ICA-AKI criteria, 3) Absence of shock, 4) No current or recent treatment with nephrotoxic drugs, and 5) Absence of parenchymal renal disease as indicated by proteinuria >500 mg/day, microhematuria (> 50 red blood cells per high power field) and/or abnormal renal ultrasonography.
Time Frame
Up to 24 weeks
Title
Percentage of Participants With Infection
Description
The occurrence of bacterial, fungal, or viral infections was recorded. An infection was considered definite in participants with clinical evidence of infection and a positive culture from a normally sterile source (with the exception of spontaneous bacterial peritonitis).
Time Frame
Up to 24 weeks
Title
Length of Hospital Stay
Description
Length of initial hospital stay from first dose date of study drug was calculated for participants who were released from initial hospitalization separately from those who died during their initial hospitalization.
Time Frame
Up to 24 weeks
Title
Change From Baseline in Liver Biochemistry Tests: Alanine Aminotransferase (ALT)
Description
Change from Baseline was calculated as the value at endpoint minus the value at Baseline.
Time Frame
Baseline (Day 1) and up to 24 weeks
Title
Change From Baseline in Liver Biochemistry Tests: Aspartate Aminotransferase (AST)
Description
Change from Baseline was calculated as the value at endpoint minus the value at Baseline.
Time Frame
Baseline (Day 1) and up to 24 weeks
Title
Change From Baseline in Liver Biochemistry Tests: Gamma Glutamyl Transferase (GGT)
Description
Change from Baseline was calculated as the value at endpoint minus the value at Baseline.
Time Frame
Baseline (Day 1) and up to 24 weeks
Title
Change From Baseline in Liver Biochemistry Tests: Alkaline Phosphatase
Description
Change from Baseline was calculated as the value at endpoint minus the value at Baseline.
Time Frame
Baseline (Day 1) and up to 24 weeks
Title
Change From Baseline in Liver Biochemistry Tests: Bilirubin
Description
Change from Baseline was calculated as the value at endpoint minus the value at Baseline.
Time Frame
Baseline (Day 1) and up to 24 weeks
Title
Change From Baseline in Liver Biochemistry Tests: Albumin
Description
Change from Baseline was calculated as the value at endpoint minus the value at Baseline.
Time Frame
Baseline (Day 1) and up to 24 weeks
Title
Change From Baseline in Liver Biochemistry Tests: International Normalized Ratio (INR)
Description
Change from Baseline was calculated as the value at endpoint minus the value at Baseline.
Time Frame
Baseline (Day 1) and up to 24 weeks
Title
Percentage of Participants With Lille Response (Score < 0.45) at Day 7
Description
The Lille score is a tool used to predict which participants with severe alcoholic hepatitis (AH) were not responding to corticosteroid therapy. It ranges between 0 and 1, with low scores (< 0.16) indicating complete response or positive response to steroids (continue therapy) and high scores (≥ 0.56) indicating no response or poor response to steroids (stop therapy). The Lille score was calculated using baseline factors: age, albumin, total bilirubin, serum creatinine, prothrombin time; and the change in total bilirubin between baseline (Day 1) and Day 7. Lille response was defined as having a Lille score < 0.45.
Time Frame
Day 7
Title
Percentage of Participants With a Lille Null Response (Score ≥ 0.56) at Day 7
Description
The Lille score is a tool used to predict which participants with severe AH were not responding to corticosteroid therapy. It ranges between 0 and 1, with low scores (< 0.16) indicating complete response or positive response to steroids (continue therapy) and high scores (≥ 0.56) indicating no response or poor response to steroids (stop therapy). The Lille score was calculated using baseline factors: age, albumin, total bilirubin, serum creatinine, prothrombin time; and the change in total bilirubin between baseline (Day 1) and Day 7. Lille null response was defined as having a Lille score ≥ 0.56.
Time Frame
Day 7
Title
Lille Score at Day 7 as a Continuous Variable
Description
The Lille score is a tool used to predict which participants with severe AH were not responding to corticosteroid therapy. It ranges between 0 and 1, with low scores (< 0.16) indicating complete response or positive response to steroids (continue therapy) and high scores (≥ 0.56) indicating no response or poor response to steroids (stop therapy). The Lille score was calculated using baseline factors: age, albumin, total bilirubin, serum creatinine, prothrombin time; and the change in total bilirubin between baseline (Day 1) and Day 7.
Time Frame
Day 7
Title
Percentage of Participants With Estimated Mortality at Month 2 and Month 6: Combined Scoring Including Lille Score at Day 7 and Baseline Model for End-Stage Liver Disease (MELD) Score
Description
The Lille score is a tool used to predict which participants with severe AH were not responding to corticosteroid therapy. It ranges between 0 and 1, with low scores (< 0.16) indicating complete response or positive response to steroids (continue therapy) and high scores (≥ 0.56) indicating no response or poor response to steroids (stop therapy). MELD scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40, with higher scores indicating greater disease severity. A scoring system combining the Lille score at Day 7 and the baseline MELD score was used to calculate the percentage of participants expected to die by Month 2 and by Month 6.
Time Frame
Baseline and Day 7 Time Points used to calculate Overall Mortality Risk at Months 2 and 6
Title
Change From Baseline in Prognostic Index: Model for End-Stage Liver Disease (MELD) Score
Description
MELD scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40, with higher scores indicating greater disease severity. Change from Baseline was calculated as the value at endpoint minus the value at Baseline.
Time Frame
Baseline (Day 1) and up to 24 weeks
Title
Change From Baseline in Prognostic Index: Child-Pugh-Turcotte (CPT) Score
Description
CPT scores are used to assess the severity of cirrhosis. Scores can range from 5 to 15, with higher scores indicating a greater severity of disease
Time Frame
Baseline (Day 1) and up to 24 weeks
Title
Change From Baseline in Prognostic Index: Maddrey Discriminant Function (DF) Score
Description
Baseline Maddrey DF score is a prognostic tool used to determine the next step of treatment based on the severity of AH. Maddrey DF score of < 32 indicates mild to moderate AH and a lower chance of death in the next few months. Maddrey DF score of ≥ 32 indicates severe AH and a higher chance of death in the next few months. The score has no bounds.
Time Frame
Baseline (Day 1) and up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Willing and able to give informed consent prior to any study specific procedures being performed. In individuals with hepatic encephalopathy (HE) which may impair decision-making, consent will be obtained per hospital procedures (eg, by Legally Authorized Representative)
Clinical diagnosis of severe AH
Maddrey's Discriminant Function (DF) ≥ 32 at screening
Key Exclusion Criteria:
Pregnant or lactating females;
Other causes of liver disease including chronic hepatitis B (hepatitis B surface antigen [HBsAg] positive), chronic hepatitis C (HCV RNA positive), acetaminophen hepatotoxicity, biliary obstruction, and autoimmune liver disease;
Serum aspartate aminotransferase (AST) >400 U/L or alanine aminotransferase (ALT) >300 U/L;
Model for End Stage Liver Disease (MELD) >30 at screening;
Maddrey's DF >60 at screening;
Grade 4 Hepatic Encephalopathy (HE) by West Haven criteria;
Concomitant or previous history of hepatocellular carcinoma;
History of liver transplantation;
HIV Ab positive;
Clinical suspicion of pneumonia;
Uncontrolled sepsis;
Uncontrolled gastrointestinal (GI) bleeding or controlled GI bleeding within 7 days of screening that was associated with shock or required transfusion of more than 3 units of blood;
Type 1 hepatorenal syndrome (HRS) or renal failure defined as a serum creatinine >221 μmol/L (>2.5 mg/dL) or the requirement for renal replacement therapy;
Individuals dependent on inotropic (eg, epinephrine or norepinephrine) or ventilatory support (ie, endotracheal intubation or positive-pressure ventilation);
Portal vein thrombosis;
Acute pancreatitis;
Cessation of alcohol consumption for more than 2 months before Baseline/ Day 1
Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Southern California Research Centers
City
Coronado
State/Province
California
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
Country
United States
Facility Name
Oschner Medical Center
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Methodist Healthcare Dallas - The Liver Institute
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Liver Institute of Virginia
City
Newport News
State/Province
Virginia
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Medizinische Universitat Graz
City
Graz
Country
Austria
Facility Name
Universitätsklinik für Innere Medizin I
City
Innsbruck
Country
Austria
Facility Name
Medical University Vienna
City
Vienna
Country
Austria
Facility Name
Cliniques Universitaires UCL Saint-Luc
City
Brussels
Country
Belgium
Facility Name
CUB Hopital Erasme
City
Brussels
Country
Belgium
Facility Name
Ghent University Hospital
City
Ghent
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven
City
Leuven
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Liege
City
Liège
Country
Belgium
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
CHU Amiens Picardie
City
Amiens
Country
France
Facility Name
CHU Angers
City
Angers
Country
France
Facility Name
Hôpital Jean Minjoz
City
Besançon
Country
France
Facility Name
C.H.U. de Caen
City
Caen
Country
France
Facility Name
CHU henri Mondor
City
Créteil
Country
France
Facility Name
CHU de Grenoble- Hopital Michallon
City
La Tronche
Country
France
Facility Name
CHRU de Lille
City
Lille
Country
France
Facility Name
Hôpital de la Croix Rousse
City
Lyon
Country
France
Facility Name
Hopital La Pitie Salpetriere
City
Paris
Country
France
Facility Name
Hopital Paul Brousse
City
Villejuif
Country
France
Facility Name
University of Zurich
City
Zurich
Country
Switzerland
Facility Name
Brighton & Sussex University Hospitals NHS Trust
City
Brighton
Country
United Kingdom
Facility Name
Hull and East Yorkshire Hospitals NHS Trust
City
Hull
Country
United Kingdom
Facility Name
Royal Liverpool & Broadgreen University Hospitals NHS Trust
City
Liverpool
Country
United Kingdom
Facility Name
Barts Health NHS Trust
City
London
Country
United Kingdom
Facility Name
Chelsea and Westminster Hospital
City
London
Country
United Kingdom
Facility Name
Imperial College
City
London
Country
United Kingdom
Facility Name
Kings College Hospital NHS Trust
City
London
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
Country
United Kingdom
Facility Name
Portsmouth Hospitals NHS Trust
City
Portsmouth
Country
United Kingdom
12. IPD Sharing Statement
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Selonsertib in Combination With Prednisolone Versus Prednisolone Alone in Participants With Severe Alcoholic Hepatitis (AH)
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