Back to resultsStudy to Evaluate the Safety and Efficacy of Selonsertib, Firsocostat, Cilofexor, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (ATLAS)
Primary Purpose
Nonalcoholic Steatohepatitis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SEL
FIR
CILO
Placebo to match FIR
Placebo to match CILO
Placebo to match SEL
Sponsored by
About this trial
This is an interventional treatment trial for Nonalcoholic Steatohepatitis
Eligibility Criteria
Key Inclusion Criteria:
- Liver biopsy consistent with NASH and F3 or F4 in the opinion of the central reader
- In participants who have never had a liver biopsy, liver stiffness by FibroScan® ≥ 14.0 kPa and Enhanced Liver Fibrosis (ELF™) Test score ≥ 9.8 at Screening
Screening laboratory parameters, as determined by the central laboratory:
- Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min, as calculated by the Cockcroft-Gault equation
- Hemoglobin A1c (HbA1c) ≤ 9.5%
- Alanine aminotransferase (ALT) < 5 x Upper Limits of Normal (ULN)
- Platelet count ≥ 125,000/μL
Key Exclusion Criteria:
- Prior history of decompensated liver disease including ascites, hepatic encephalopathy, or variceal bleeding
- Child-Pugh (CP) score > 6 at Screening, unless due to an alternative etiology such as Gilbert's syndrome or therapeutic anticoagulation
- Model for End-Stage Liver Disease (MELD) score > 12 at Screening, unless due to an alternate etiology such as therapeutic anticoagulation
- Other causes of liver disease based on medical history and/or centralized review of liver histology, including but not limited to: alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders (eg, primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency requiring treatment
- History of liver transplantation
- Current or prior history of hepatocellular carcinoma
Note: Other protocol defined Inclusion/ Exclusion criteria may apply
Sites / Locations
- The Institute for Liver Health
- Mayo Clinic Arizona, Mayo Clinic Hospital
- Liver Wellness Center
- Arkansas Gastroenterology
- eStudySite
- Southern California Liver Center
- Fresno Clinical Research Center
- UCSD NAFLD Clinical Research Center
- Ruane Clinical Research Group Inc.
- Cedars-Sinai Medical Center
- California Liver Research Institute
- Huntington Medical Research Institutes Liver Center
- Inland Empire Liver Foundation
- University of California, Davis Medical Center (study visits)
- Medical Associates Research Group
- South Denver Gastroenterology, PC
- Integrity Clinical Research
- UF Hepatology Research at CTRB
- Schiff Center for Liver Diseases/University of Miami
- IMIC Inc
- Genoma Research Group
- Florida Research Institute
- Digestive Healthcare of Georgia
- Piedmont Hospital
- Gastrointestinal Diseases Research
- Gastrointestinal Specialists of Georgia
- Northwestern University; Feinberg School of Medicine
- Indianapolis Gastroenterology Research Foundation
- Iowa Digestive Disease Center, P.C.
- University of Kansas Medical Center
- Delta Research Partners, LLC
- Tulane University
- Louisiana Research Center, LLC
- Mercy Medical Center
- Digestive Disease Associates, PA
- Beth Israel Deaconess Medical Center
- Henry Ford Health Systems
- Mayo Clinic
- Southern Therapy and Advanced Research (STAR) LLC
- Saint Luke's Hospital of Kansas City
- Saint Louis University
- Jubilee Clinical Research, Inc.
- Rutgers New Jersey Medical School- Doctors Office Center
- Montefiore Medical Center
- Sandra Atlas Bass Center for Liver Diseases and Transplantation
- Icahn School of Medicine at Mount Sinai Beth Israel
- Concorde Medical Group, PLLC
- NYU Langone Health
- Weill Cornell Medical College
- Icahn School of Medicine at Mount Sinai
- Carolinas Healthcare System Center for Liver Disease and Transplant
- Duke University Medical Center, Duke South Clinics
- Cumberland Research Associates, LLC
- Consultants for Clinical Research wed
- Hospital of the University of Pennsylvania- Perelman Center for Advanced Medicine
- Thomas Jefferson University
- UPMC - Center for Liver Diseases at the Thomas E. Starlz Institute
- VA Pittsburgh Healthcare System
- University Gastroenterology
- Medical University of South Carolina (Liver Biopsy)
- GHS Gastroenterology and Liver Center
- Gastro One
- Quality Medical Research, PLLC
- Texas Clinical Research Institute, LLC
- Pinnacle Clinical Research, PLLC
- Austin Center for Clinical Research
- The Liver Institute at Methodist Dallas Medical Center
- University of Texas Southwestern Medical Center Internal Medicine Digestive and Liver Diseases Clinical Trials
- Baylor College of Medicine - Advanced Liver Therapies
- Houston Methodist Hospital
- Pinnacle Clinical Research
- American Research Corporation at Texas Liver Institute
- Intermountain Liver Disease and Transplant Center
- University of Utah Hospital
- University of Virginia Medical Center
- California Pacific Medical Center - Sutter Pacific Medical Foundation San Francisco Center for Liver Disease Dept. of Transplant
- Digestive and Liver Disease Specialists
- Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours Liver Institute of Richmond
- McGuire DVAMC
- Virginia Mason Medical Center
- Swedish Organ Transplant and Liver Center
- Royal Brisbane & Women's Hospital
- Royal Adelaide Hospital
- Monash Health, Monash Medical Centre
- St Vincent's Hospital Melbourne
- Melbourne Health, Royal Melbourne Hospital
- Sir Charles Gairdner Hospital
- Royal Perth Hospital
- Royal Prince Alfred Hospital
- St Vincent's Hospital Sydney
- Austin Health
- The Alfred Hospital, Alfred Health
- Westmead Hospital
- William Osler Health System-Brampton Civic Hospital
- University of Calgary Liver Unit (Heritage Medical Research Clinic)
- Chronic Viral Illness Service McGill University Health Centre (MUHC)/ Royal Victoria Hospital
- Toronto General Hospital
- Toronto Liver Centre
- Prince of Wales Hospital
- Auckland City Hospital
- Fundacion de Investigacion de Diego
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Selonsertib (SEL)
Firsocostat (FIR)
Cilofexor (CILO)
Selonsertib (SEL) + Firsocostat (FIR)
Selonsertib (SEL) + Cilofexor (CILO)
Firsocostat (FIR) + Cilofexor (CILO)
Placebo
Arm Description
Participants will receive SEL + placebo to match firsocostat 20 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 48 weeks.
Participants will receive placebo to match SEL 18 mg tablet + FIR + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
Participants will receive placebo to match SEL 18 mg tablet + placebo to match FIR 20 mg tablet + CILO orally once daily for 48 weeks.
Participants will receive SEL + FIR + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
Participants will receive SEL + placebo to match FIR 20 mg tablet + CILO orally once daily for 48 weeks.
Participants will receive placebo to match SEL 18 mg tablet + FIR + CILO orally once daily for 48 weeks.
Participants will receive placebo to match SEL 18 mg + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
Outcomes
Primary Outcome Measures
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. Participants with any laboratory abnormality were reported.
Percentage of Participants Who Achieved a ≥ 1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 48
Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH clinical research network classification (CRN) classification. Worsening of NASH was defined as ≥ 1-point increase from baseline in hepatocellular ballooning or lobular inflammation. The 95% CI was based on the Clopper-Pearson method.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03449446
Brief Title
Study to Evaluate the Safety and Efficacy of Selonsertib, Firsocostat, Cilofexor, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
Acronym
ATLAS
Official Title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib, GS-0976, GS-9674, and Combinations in Subjects With Bridging (F3) Fibrosis or Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
March 21, 2018 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
November 19, 2019 (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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objectives of this study are:
To assess the safety and tolerability of selonsertib (SEL), firsocostat (FIR) and cilofexor (CILO), administered alone or in combination, in participants with bridging fibrosis or compensated cirrhosis due to NASH
To evaluate changes in liver fibrosis, without worsening of NASH
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Steatohepatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
395 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Selonsertib (SEL)
Arm Type
Experimental
Arm Description
Participants will receive SEL + placebo to match firsocostat 20 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 48 weeks.
Arm Title
Firsocostat (FIR)
Arm Type
Experimental
Arm Description
Participants will receive placebo to match SEL 18 mg tablet + FIR + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
Arm Title
Cilofexor (CILO)
Arm Type
Experimental
Arm Description
Participants will receive placebo to match SEL 18 mg tablet + placebo to match FIR 20 mg tablet + CILO orally once daily for 48 weeks.
Arm Title
Selonsertib (SEL) + Firsocostat (FIR)
Arm Type
Experimental
Arm Description
Participants will receive SEL + FIR + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
Arm Title
Selonsertib (SEL) + Cilofexor (CILO)
Arm Type
Experimental
Arm Description
Participants will receive SEL + placebo to match FIR 20 mg tablet + CILO orally once daily for 48 weeks.
Arm Title
Firsocostat (FIR) + Cilofexor (CILO)
Arm Type
Experimental
Arm Description
Participants will receive placebo to match SEL 18 mg tablet + FIR + CILO orally once daily for 48 weeks.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Participants will receive placebo to match SEL 18 mg + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
Intervention Type
Drug
Intervention Name(s)
SEL
Intervention Description
18 mg tablet administered orally once daily without regard to food
Intervention Type
Drug
Intervention Name(s)
FIR
Other Intervention Name(s)
GS-0976
Intervention Description
20 mg tablet administered orally once daily without regard to food
Intervention Type
Drug
Intervention Name(s)
CILO
Other Intervention Name(s)
GS-9674
Intervention Description
30 mg tablet administered orally once daily without regard to food
Intervention Type
Drug
Intervention Name(s)
Placebo to match FIR
Intervention Description
Tablet administered orally once daily without regard to food
Intervention Type
Drug
Intervention Name(s)
Placebo to match CILO
Intervention Description
Tablet administered orally once daily without regard to food
Intervention Type
Drug
Intervention Name(s)
Placebo to match SEL
Intervention Description
Tablet administered orally once daily without regard to food
Primary Outcome Measure Information:
Title
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Time Frame
First dose date up to 48 weeks plus 30 days
Title
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Description
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. Participants with any laboratory abnormality were reported.
Time Frame
First dose date up to 48 weeks plus 30 days
Title
Percentage of Participants Who Achieved a ≥ 1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 48
Description
Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH clinical research network classification (CRN) classification. Worsening of NASH was defined as ≥ 1-point increase from baseline in hepatocellular ballooning or lobular inflammation. The 95% CI was based on the Clopper-Pearson method.
Time Frame
Week 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Liver biopsy consistent with NASH and F3 or F4 in the opinion of the central reader
In participants who have never had a liver biopsy, liver stiffness by FibroScan® ≥ 14.0 kPa and Enhanced Liver Fibrosis (ELF™) Test score ≥ 9.8 at Screening
Screening laboratory parameters, as determined by the central laboratory:
Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min, as calculated by the Cockcroft-Gault equation
Hemoglobin A1c (HbA1c) ≤ 9.5%
Alanine aminotransferase (ALT) < 5 x Upper Limits of Normal (ULN)
Platelet count ≥ 125,000/μL
Key Exclusion Criteria:
Prior history of decompensated liver disease including ascites, hepatic encephalopathy, or variceal bleeding
Child-Pugh (CP) score > 6 at Screening, unless due to an alternative etiology such as Gilbert's syndrome or therapeutic anticoagulation
Model for End-Stage Liver Disease (MELD) score > 12 at Screening, unless due to an alternate etiology such as therapeutic anticoagulation
Other causes of liver disease based on medical history and/or centralized review of liver histology, including but not limited to: alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders (eg, primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency requiring treatment
History of liver transplantation
Current or prior history of hepatocellular carcinoma
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
The Institute for Liver Health
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224-5688
Country
United States
Facility Name
Mayo Clinic Arizona, Mayo Clinic Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Liver Wellness Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72204
Country
United States
Facility Name
Arkansas Gastroenterology
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
eStudySite
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911-6660
Country
United States
Facility Name
Southern California Liver Center
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
Fresno Clinical Research Center
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
UCSD NAFLD Clinical Research Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Ruane Clinical Research Group Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
99352
Country
United States
Facility Name
California Liver Research Institute
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Huntington Medical Research Institutes Liver Center
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Inland Empire Liver Foundation
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Facility Name
University of California, Davis Medical Center (study visits)
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Medical Associates Research Group
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
South Denver Gastroenterology, PC
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Integrity Clinical Research
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
UF Hepatology Research at CTRB
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Schiff Center for Liver Diseases/University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
IMIC Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Genoma Research Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Florida Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
34211
Country
United States
Facility Name
Digestive Healthcare of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Gastrointestinal Diseases Research
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Gastrointestinal Specialists of Georgia
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Northwestern University; Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Indianapolis Gastroenterology Research Foundation
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Iowa Digestive Disease Center, P.C.
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Delta Research Partners, LLC
City
Bastrop
State/Province
Louisiana
ZIP/Postal Code
71220
Country
United States
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Louisiana Research Center, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Digestive Disease Associates, PA
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Health Systems
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Southern Therapy and Advanced Research (STAR) LLC
City
Ridgeland
State/Province
Mississippi
ZIP/Postal Code
39157
Country
United States
Facility Name
Saint Luke's Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Jubilee Clinical Research, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Rutgers New Jersey Medical School- Doctors Office Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Sandra Atlas Bass Center for Liver Diseases and Transplantation
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai Beth Israel
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Concorde Medical Group, PLLC
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Carolinas Healthcare System Center for Liver Disease and Transplant
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke University Medical Center, Duke South Clinics
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cumberland Research Associates, LLC
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Consultants for Clinical Research wed
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
Hospital of the University of Pennsylvania- Perelman Center for Advanced Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
UPMC - Center for Liver Diseases at the Thomas E. Starlz Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
VA Pittsburgh Healthcare System
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Name
University Gastroenterology
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Medical University of South Carolina (Liver Biopsy)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
GHS Gastroenterology and Liver Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Gastro One
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Quality Medical Research, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Texas Clinical Research Institute, LLC
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Pinnacle Clinical Research, PLLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
Facility Name
Austin Center for Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
The Liver Institute at Methodist Dallas Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
University of Texas Southwestern Medical Center Internal Medicine Digestive and Liver Diseases Clinical Trials
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Baylor College of Medicine - Advanced Liver Therapies
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pinnacle Clinical Research
City
Live Oak
State/Province
Texas
ZIP/Postal Code
78233
Country
United States
Facility Name
American Research Corporation at Texas Liver Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Intermountain Liver Disease and Transplant Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Utah Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
California Pacific Medical Center - Sutter Pacific Medical Foundation San Francisco Center for Liver Disease Dept. of Transplant
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Digestive and Liver Disease Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours Liver Institute of Richmond
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
McGuire DVAMC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Swedish Organ Transplant and Liver Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Royal Brisbane & Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Monash Health, Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
St Vincent's Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Melbourne Health, Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
ZIP/Postal Code
2050
Country
Australia
Facility Name
St Vincent's Hospital Sydney
City
Darlinghurst
ZIP/Postal Code
2010
Country
Australia
Facility Name
Austin Health
City
Heidelberg
ZIP/Postal Code
3084
Country
Australia
Facility Name
The Alfred Hospital, Alfred Health
City
Melbourne
ZIP/Postal Code
3004
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Facility Name
William Osler Health System-Brampton Civic Hospital
City
Brampton
ZIP/Postal Code
L6R 3J7
Country
Canada
Facility Name
University of Calgary Liver Unit (Heritage Medical Research Clinic)
City
Calgary
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Chronic Viral Illness Service McGill University Health Centre (MUHC)/ Royal Victoria Hospital
City
Montreal
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Toronto Liver Centre
City
Toronto
ZIP/Postal Code
M6H 3M1
Country
Canada
Facility Name
Prince of Wales Hospital
City
Shatin
Country
Hong Kong
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Fundacion de Investigacion de Diego
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Loomba R, et al. Safety and efficacy of combination therapies including cilofexor/firsocostat in patients with bridging fibrosis and cirrhosis due to NASH: Results of the Phase 2b ATLAS trial [accepted for oral presentation]. European Association for the Study of the Liver (EASL); 2020; Virtual.
Results Reference
result
Citation
Loomba R, Alkhouri N, Strasser S, Wong VWS, Schall RA, McColgan B, et al. Clinical utility and application of non-invasive tests of fibrosis in the selection of patients with advanced fibrosis due to NASH in the Phase 2 ATLAS trial (Poster SAT-315). EASL; 2019; Vienna, Austria.
Results Reference
result
Citation
Loomba R, Alkhouri N, Patel K, Zhang J, McColgan BJ, Djedjos S, et al. Validation of Cutoffs for Controlled Attenuation Parameter with MRI-Proton Density Fat Fraction (PDFF) as a Reference Standard in Subjects with Nonalcoholic Steatohepatitis (NASH) Across Multiple Randomized, Controlled Trials (Poster 1727). American Association for the Study of Liver Diseases (AASLD); 2019; Boston, MA, USA.
Results Reference
result
Citation
Loomba R, Alkhouri N, Noureddin M, Zhang J, McColgan BJ, Djedjos S, et al. Validation of the Diagnostic Accuracy of Magnetic Resonance Elastography (MRE) for the Detection of Advanced Fibrosis Due to Nash Across Multiple Phase 2 and 3 Clinical Trials (Poster 1728). AASLD; 2019; Boston, MA, USA.
Results Reference
result
Citation
Alkhouri N, Strasser SI, Wong VWS, Aguilar R, Chuang J, Huss R, et al. Alcohol use is Underreported in Clinical Trials of NASH: Baseline Alcohol Biomarkers from a Phase 2 Clinical Trial (Poster 1765). AASLD; 2019; Boston, MA, USA.
Results Reference
result
PubMed Identifier
33169409
Citation
Loomba R, Noureddin M, Kowdley KV, Kohli A, Sheikh A, Neff G, Bhandari BR, Gunn N, Caldwell SH, Goodman Z, Wapinski I, Resnick M, Beck AH, Ding D, Jia C, Chuang JC, Huss RS, Chung C, Subramanian GM, Myers RP, Patel K, Borg BB, Ghalib R, Kabler H, Poulos J, Younes Z, Elkhashab M, Hassanein T, Iyer R, Ruane P, Shiffman ML, Strasser S, Wong VW, Alkhouri N; for the ATLAS Investigators. Combination Therapies Including Cilofexor and Firsocostat for Bridging Fibrosis and Cirrhosis Attributable to NASH. Hepatology. 2021 Feb;73(2):625-643. doi: 10.1002/hep.31622.
Results Reference
derived
Learn more about this trial
Study to Evaluate the Safety and Efficacy of Selonsertib, Firsocostat, Cilofexor, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
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