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Safety and Efficacy of Simtuzumab (SIM, GS-6624) in Adults With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)

Primary Purpose

Liver Fibrosis Due to NASH

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
SIM
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Fibrosis Due to NASH focused on measuring NASH, noncirrhotic, Monoclonal antibody, LOXL2, Simtuzumab, Nonalcoholic Steatohepatitis, NAFLD, Liver biopsy, MRE, Liver fibrosis, Ishak

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Adults with chronic liver disease due to NASH defined as macrovesicular steatosis involving > 5% of hepatocytes on a liver biopsy with associated lobular inflammation
  • Stage 3-4 fibrosis by Ishak score on a liver biopsy
  • Exclusion of other causes of liver disease including viral hepatitis and alcoholic liver disease
  • Must have aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 10 x Central Laboratory Upper Limit of Normal (clULN)
  • Must have serum creatinine < 2.0 mg/dL
  • A negative serum pregnancy test is required for females of childbearing potential
  • All sexually active females of childbearing potential must agree to use a protocol recommended method of contraception during intercourse throughout the study and for 90 days following the last dose of study medication
  • Lactating females must agree to discontinue nursing before starting study treatment
  • Males, if not vasectomized, are required to use barrier contraception (condom plus spermicide) during heterosexual intercourse from the screening through the study completion and for 90 days following the last dose of study drug.

Key Exclusion Criteria:

  • Pregnant or breast feeding
  • Cirrhosis of the liver
  • Any history of hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding
  • Weight reduction surgery in the past 5 years
  • Positive for hepatitis C virus (HCV) RNA
  • Positive for HBsAg
  • Alcohol consumption greater than 21oz/week for males or 14oz/week for females
  • Positive urine screen for amphetamines, cocaine or opiates (i.e. heroin, morphine) at screening.
  • Clinically significant cardiac disease
  • History of malignancy, other than non-melanomatous skin cancer, within 5 years prior to screening
  • Major surgical procedure within 30 days prior to screening or the presence of an open wound
  • Known hypersensitivity to the investigation product or any of its formulation excipients
  • History of bleeding diathesis within 6 months of screening
  • Unavailable for follow-up assessment or concern for individual's compliance with the protocol procedures;
  • Participation in an investigational trial of a drug or device within 30 days prior to screening
  • BMI < 18 kg/m^2

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

  • Mayo Clinic Hospital
  • Southern California Liver Centers
  • University of California, San Diego (UCSD)
  • University of California San Francisco (UCSF)
  • University of Colorado
  • Miami Veterans Administration Healthcare System
  • Tampa General Hospital
  • Northwestern University
  • Indianapolis Gastroenterology Research Foundation
  • Iowa Digestive Disease Center
  • University of Louisville
  • Tulane University
  • Mercy Medical Center
  • Walter Reed National Military Medical Center
  • Beth Israel Deaconess Medical Center
  • Lahey Clinic
  • University of Michigan
  • Minnnesota Gastroenterology, PA
  • University of Mississippi Medical Center
  • Saint Louis University Hospital
  • State University Of New York
  • Weill Cornell Medical College
  • Mount Sinai Hospital
  • Duke University
  • University Hospitals Case Medical Center
  • Cleveland Clinic
  • University of Pennsylvania
  • University Gastroenterology
  • Medical University of South Carolina
  • Texas Clinical Research Institute, LLC
  • Brooke Army Medical Center
  • St. Luke's Episcopal Hospital
  • Alamo Clinical Research Associates
  • University of Utah
  • University of Virginia Health System
  • Liver Institute of Virginia
  • Digestive and Liver Disease Specialists
  • Bucheon St. Marys Hospital
  • Virginia Commonwealth University Health System
  • Virginia Mason Medical Center
  • University of Washington
  • Hôpital Erasme
  • Université Catholique de Louvain
  • UZ Ghent
  • University of Calgary
  • University of Manitoba
  • London Health Science Center
  • Toronto Liver Centre
  • Hopital Beaujon
  • Hospital Saint-Antoine
  • Groupe Hospitalier Pitié- Salpétrière
  • CHU Strasbourg Hôpital Civil
  • Medizinische Hochschule Hannover
  • Gastroenterologisch-Hepatologisches Zentrum Kiel
  • EUGASTRO GmbH
  • Azienda Ospedaliero-Universitaria di Modena Policlinico
  • Azienda Ospedaliera San Camillo Forlanini
  • Azienda Ospedaliera Città della Salute e della Scienza di Torino
  • Fundacion De Investigacion
  • Hospital Vall d'Hebron
  • Hospital Clinic de Barcelona
  • Hospital Universitario Puerta de Hierro
  • Hospital Donostia
  • John Radcliffe Hospital
  • The Royal London Hospital
  • Royal Free Hospital, Pond Street
  • King's College Hospital NHS Foundation Trust No. 1 Account
  • Nottingham University Hospitals Queens Medica

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

SIM 75 mg

SIM 125 mg

Placebo

Arm Description

During the Randomized Double-Blind Phase, participants will receive SIM 75 mg via subcutaneous injection once weekly for up to 240 weeks. During the optional Open-Label Phase, participants will receive SIM 125 mg via subcutaneous injection once weekly for up to an additional 240 weeks.

During the Randomized Double-Blind Phase, participants will receive SIM 125 mg via subcutaneous injection once weekly for up to 240 weeks. During the optional Open-Label Phase, participants will receive SIM 125 mg via subcutaneous injection once weekly for up to an additional 240 weeks.

During the Randomized Double-Blind Phase, participants will receive placebo to match SIM via subcutaneous injection once weekly for up to 240 weeks. During the optional Open-Label Phase, participants will receive SIM 125 mg via subcutaneous injection once weekly for up to an additional 240 weeks.

Outcomes

Primary Outcome Measures

Change From Baseline in MQC on Liver Biopsy
Event Free Survival (EFS) Using Kaplan-Meier
The EFS was the primary clinical efficacy endpoint and was assessed by the time to progression to cirrhosis. Participants were considered to have become cirrhotic if they had a post-baseline biopsy consistent with cirrhosis or developed overt signs and symptoms of cirrhosis. All overt signs and symptoms went through an adjudication process and were confirmed before they were considered for the EFS analysis.

Secondary Outcome Measures

Full Information

First Posted
August 22, 2012
Last Updated
March 1, 2019
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01672866
Brief Title
Safety and Efficacy of Simtuzumab (SIM, GS-6624) in Adults With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)
Official Title
A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase-Like Molecule 2 (LOXL2), in Subjects With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Study Start Date
December 5, 2012 (Actual)
Primary Completion Date
August 2, 2016 (Actual)
Study Completion Date
December 29, 2016 (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 whether SIM (formerly referred to as GS-6624) is effective at preventing the histologic progression of liver fibrosis and the clinical progression to cirrhosis in participants with NASH. It will consist of 2 phases: Randomized Double-Blind Phase Open-Label Phase (optional)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Fibrosis Due to NASH
Keywords
NASH, noncirrhotic, Monoclonal antibody, LOXL2, Simtuzumab, Nonalcoholic Steatohepatitis, NAFLD, Liver biopsy, MRE, Liver fibrosis, Ishak

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SIM 75 mg
Arm Type
Experimental
Arm Description
During the Randomized Double-Blind Phase, participants will receive SIM 75 mg via subcutaneous injection once weekly for up to 240 weeks. During the optional Open-Label Phase, participants will receive SIM 125 mg via subcutaneous injection once weekly for up to an additional 240 weeks.
Arm Title
SIM 125 mg
Arm Type
Experimental
Arm Description
During the Randomized Double-Blind Phase, participants will receive SIM 125 mg via subcutaneous injection once weekly for up to 240 weeks. During the optional Open-Label Phase, participants will receive SIM 125 mg via subcutaneous injection once weekly for up to an additional 240 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
During the Randomized Double-Blind Phase, participants will receive placebo to match SIM via subcutaneous injection once weekly for up to 240 weeks. During the optional Open-Label Phase, participants will receive SIM 125 mg via subcutaneous injection once weekly for up to an additional 240 weeks.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo to match SIM via subcutaneous injection every week
Intervention Type
Biological
Intervention Name(s)
SIM
Other Intervention Name(s)
GS-6624
Intervention Description
Subcutaneous injection every week
Primary Outcome Measure Information:
Title
Change From Baseline in MQC on Liver Biopsy
Time Frame
Baseline to Week 96
Title
Event Free Survival (EFS) Using Kaplan-Meier
Description
The EFS was the primary clinical efficacy endpoint and was assessed by the time to progression to cirrhosis. Participants were considered to have become cirrhotic if they had a post-baseline biopsy consistent with cirrhosis or developed overt signs and symptoms of cirrhosis. All overt signs and symptoms went through an adjudication process and were confirmed before they were considered for the EFS analysis.
Time Frame
Baseline up to the time of progression to cirrhosis or last dose date (maximum: 240 weeks in the Blinded Phase), which ever occurred first

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Adults with chronic liver disease due to NASH defined as macrovesicular steatosis involving > 5% of hepatocytes on a liver biopsy with associated lobular inflammation Stage 3-4 fibrosis by Ishak score on a liver biopsy Exclusion of other causes of liver disease including viral hepatitis and alcoholic liver disease Must have aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 10 x Central Laboratory Upper Limit of Normal (clULN) Must have serum creatinine < 2.0 mg/dL A negative serum pregnancy test is required for females of childbearing potential All sexually active females of childbearing potential must agree to use a protocol recommended method of contraception during intercourse throughout the study and for 90 days following the last dose of study medication Lactating females must agree to discontinue nursing before starting study treatment Males, if not vasectomized, are required to use barrier contraception (condom plus spermicide) during heterosexual intercourse from the screening through the study completion and for 90 days following the last dose of study drug. Key Exclusion Criteria: Pregnant or breast feeding Cirrhosis of the liver Any history of hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding Weight reduction surgery in the past 5 years Positive for hepatitis C virus (HCV) RNA Positive for HBsAg Alcohol consumption greater than 21oz/week for males or 14oz/week for females Positive urine screen for amphetamines, cocaine or opiates (i.e. heroin, morphine) at screening. Clinically significant cardiac disease History of malignancy, other than non-melanomatous skin cancer, within 5 years prior to screening Major surgical procedure within 30 days prior to screening or the presence of an open wound Known hypersensitivity to the investigation product or any of its formulation excipients History of bleeding diathesis within 6 months of screening Unavailable for follow-up assessment or concern for individual's compliance with the protocol procedures; Participation in an investigational trial of a drug or device within 30 days prior to screening BMI < 18 kg/m^2 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
Mayo Clinic Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Southern California Liver Centers
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
University of California, San Diego (UCSD)
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
University of California San Francisco (UCSF)
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Miami Veterans Administration Healthcare System
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Northwestern University
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
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Minnnesota Gastroenterology, PA
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Saint Louis University Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
State University Of New York
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
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
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
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
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Texas Clinical Research Institute, LLC
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
St. Luke's Episcopal Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Alamo Clinical Research Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Liver Institute of Virginia
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23602
Country
United States
Facility Name
Digestive and Liver Disease Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Bucheon St. Marys Hospital
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Virginia Commonwealth University Health System
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Hôpital Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Université Catholique de Louvain
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Ghent
City
Gent
ZIP/Postal Code
B-9000
Country
Belgium
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P4
Country
Canada
Facility Name
London Health Science Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Toronto Liver Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6H 3M1
Country
Canada
Facility Name
Hopital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Hospital Saint-Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Groupe Hospitalier Pitié- Salpétrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
CHU Strasbourg Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Gastroenterologisch-Hepatologisches Zentrum Kiel
City
Kiel
ZIP/Postal Code
24146
Country
Germany
Facility Name
EUGASTRO GmbH
City
Leipzig
ZIP/Postal Code
4103
Country
Germany
Facility Name
Azienda Ospedaliero-Universitaria di Modena Policlinico
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini
City
Roma
ZIP/Postal Code
152
Country
Italy
Facility Name
Azienda Ospedaliera Città della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Fundacion De Investigacion
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Donostia
City
San Sebastian
ZIP/Postal Code
20080
Country
Spain
Facility Name
John Radcliffe Hospital
City
Headington
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
The Royal London Hospital
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Royal Free Hospital, Pond Street
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trust No. 1 Account
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Nottingham University Hospitals Queens Medica
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
Citation
Sanyal A, Harrison S, Ratziu V, Abdelmalek M, Diehl A, Caldwell S, et al. Changes in fibrosis, but not the NAFLD Activity Score (NAS), are associated with disease progression in patients with nonalcoholic steatohepatitis (NASH) and advanced fibrosis. J Hepatol 2017; 66 (1): S2.
Results Reference
result
Citation
Sanyal A, Abdelmalek M, Diehl A, Caldwell S, Shiffman M, Ghalib R, et al. Efficacy and safety of simtuzumab for the treatment of nonalcoholic steatohepatitis with bridging fibrosis or cirrhosis: results of two phase 2b, dose-ranging, randomized, placebo-controlled trials. J Hepatol 2017; 66 (1): S54.
Results Reference
result
Citation
Ratziu V, Sanyal A, Torres D, Hinrichsen H, Serfaty L, Bambha K, et al. Impact of weight reduction on serum markers and liver histology including progression to cirrhosis in patients with nonalcoholic steatohepatitis (NASH) and bridging fibrosis. J Hepatol 2017; 66 (1): S594.
Results Reference
result
Citation
Shea PR, Sanyal A, Harrison S, Ratziu V, Loomba R, Caldwell S, et al. PNPLA3 variants confer an increased risk of advanced fibrosis due to non-alcoholic steatohepatitis. J Hepatol 2016; 64 (2): S493.
Results Reference
result
Citation
Shea PR, Sanyal A, Rockey DC, Loomba R, Diehl AM, Kleinstein SE, et al. Genome-wide association study of clinically significant portal hypertension in patients with nonalcoholic steatohepatitis and advanced fibrosis. J Hepatol 2016; 64 (2): S280.
Results Reference
result
Citation
Goodman ZD, Alaparthi L, Monge F, Patel K, Loomba R, Caldwell SH, et al. Correlations between hepatic morphometric collagen content, histologic fibrosis staging, and serum markers in patients with advanced fibrosis due to nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 906A.
Results Reference
result
Citation
Harrison SA, Goodman ZD, Ratziu V, Loomba R, Diehl AM, Lawitz E, et al. Serum lysyl oxidase-like-2 (sLOXL2) levels correlate with fibrosis stage in patients with nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 910A.
Results Reference
result
Citation
Ratziu V, Sanyal AJ, Loomba R, Caldwell SH, Ghalib RH, Torres DM, et al. Characterization of insulin resistance in patients with advanced fibrosis due to nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 1298A-1299A.
Results Reference
result
PubMed Identifier
33307033
Citation
Younossi ZM, Anstee QM, Wai-Sun Wong V, Trauner M, Lawitz EJ, Harrison SA, Camargo M, Kersey K, Subramanian GM, Myers RP, Stepanova M. The Association of Histologic and Noninvasive Tests With Adverse Clinical and Patient-Reported Outcomes in Patients With Advanced Fibrosis Due to Nonalcoholic Steatohepatitis. Gastroenterology. 2021 Apr;160(5):1608-1619.e13. doi: 10.1053/j.gastro.2020.12.003. Epub 2020 Dec 8.
Results Reference
derived
PubMed Identifier
29990488
Citation
Harrison SA, Abdelmalek MF, Caldwell S, Shiffman ML, Diehl AM, Ghalib R, Lawitz EJ, Rockey DC, Schall RA, Jia C, McColgan BJ, McHutchison JG, Subramanian GM, Myers RP, Younossi Z, Ratziu V, Muir AJ, Afdhal NH, Goodman Z, Bosch J, Sanyal AJ; GS-US-321-0105 and GS-US-321-0106 Investigators. Simtuzumab Is Ineffective for Patients With Bridging Fibrosis or Compensated Cirrhosis Caused by Nonalcoholic Steatohepatitis. Gastroenterology. 2018 Oct;155(4):1140-1153. doi: 10.1053/j.gastro.2018.07.006. Epub 2018 Jul 7.
Results Reference
derived

Learn more about this trial

Safety and Efficacy of Simtuzumab (SIM, GS-6624) in Adults With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)

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