Primary Sclerosing Cholangitis (PSC)Phase 2NCT01672853
Simtuzumab (GS-6624) in the Prevention of Progression of Liver Fibrosis in Adults With Primary Sclerosing Cholangitis (PSC)
A Phase 2 study testing Simtuzumab in people with Primary Sclerosing Cholangitis (PSC), run by Gilead Sciences at 75 sites in 10 countries.
Trial summary
The purpose of this study is to evaluate whether simtuzumab (GS-6624) is effective at preventing the progression of liver fibrosis in adults with primary sclerosing cholangitis (PSC). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Sclerosing Cholangitis (PSC)
- What is being tested?
- Simtuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 235 participants
- Where
- 75 sitesin 10 countries
- Study dates
- 4 Mar 2013to 24 Aug 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Individuals (aged 18-70) with chronic cholestatic liver disease of at least 6 months.
- Liver biopsy consistent with PSC: If a liver biopsy has been performed within 3 months of the screening visit, tissue from that biopsy may be used as the screening biopsy. Slides would be re-cut from the existing tissue block and submitted for central reader assessment. Some individuals with PSC may have a normal liver biopsy, in the event of a normal liver biopsy, the individual must have an abnormal magnetic resonance cholangiopancreatography (MRCP).
- MRCP consistent with PSC: Some individuals with PSC may have a normal MRCP; in the event of a normal MRCP, the individual must have an abnormal liver biopsy.
- Exclusion of other causes of liver disease including viral hepatitis ,alcoholic liver disease,primary biliary cirrhosis and secondary sclerosing cholangitis
- Must have aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 10 x the Central Laboratory Upper Limit of Normal (clULN)
- Must have serum creatinine < 2.0 mg/dL
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- A negative serum pregnancy test is required for female individuals of childbearing potential
- All sexually active female individuals of childbearing potential must agree to use a protocol recommended method of contraception during heterosexual 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 intercourse from the screening through the study completion and for 90 days following the last dose of study drug
Who cannot join
- Pregnant or breast feeding
- Evidence of hepatic decompensation present, including ascites, episodes of hepatic encephalopathy, variceal bleeding or a prolonged prothrombin time/international normalized ratio (PT/INR)
- Positive for hepatitis C virus (HCV) RNA
- Positive for HBsAg
- Positive for anti-mitochondrial antibody
- Alcohol consumption greater than 21oz/week for males or 14oz/week for females
Show all 19Show fewer
- Moderately active ulcerative colitis (UC) defined as either a partial Mayo score of > 4, bleeding score of >1, or current use of oral corticosteroid therapy and/or any inhibitor of Tumor necrosis factor-α (TNF-α) or α4β7 integrin antagonist
- Positive urine screen for amphetamines, cocaine or opiates (i.e. heroin, morphine) at screening. Individuals on stable methadone or buprenorphine maintenance treatment for at least 6 months prior to screening may be included in the study. Individuals with a positive urine drug screen due to prescription opioid-based medication are eligible if the prescription and diagnosis are reviewed and approved by the investigator
- Clinically significant cardiac disease
- History of cholangiocarcinoma
- History of other cancers,other than non-melanomatous skin cancer, within 5 years prior to screening
- Ascending cholangitis within 60 days of screening
- Presence of a percutaneous drain or bile duct stent
- 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
- Major surgical procedure within 30 days prior to screening or the presence of an open wound
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
75 sites in 10 countries.
75 sites in 10 countries
United States43 sites
University of Colorado Denver
Aurora, Colorado, 80045
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 01125
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Virginia Health Center
Charlottesville, Virginia, 22908
Northwestern University
Chicago, Illinois, 60611
Southern California Liver Center
Chula Vista, California, 91910
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
Iowa Digestive Disease Center
Clive, Iowa, 50325
Southern California Liver Centers
Coronado, California, 92118
UT Southwestern Medical Center
Dallas, Texas, 75390
Duke Clinical Research Institute
Durham, North Carolina, 27710
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
St. Luke Episcopal Hospital
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, 46237
Scripps Clinic
La Jolla, California, 92037
University of Louisville
Louisville, Kentucky, 40202
University of Miami Center for Liver Diseases
Miami, Florida, 33136
Intermountain Medical Center
Murray, Utah, 84107
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
Weill Cornell Medical College
New York, New York, 10021
Mount Sinai Hospital
New York, New York, 10029
Liver Institute of Virginia
Newport News, Virginia, 23603
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502
Verterans Adminstration Hospital
Palo Alto, California, 94304
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic Hospital
Phoenix, Arizona, 85054
University Gastroenterology
Providence, Rhode Island, 02905
Bon Secours Richmond Health System
Richmond, Virginia, 23226
Virginia Commonwealth University Health System
Richmond, Virginia, 23298
UC Davis Medical Center
Sacramento, California, 95817
Minnesota Gastroenterology, PA
Saint Paul, Minnesota, 55114
University of Utah
Salt Lake City, Utah, 84132
Alamo Medical Research
San Antonio, Texas, 78215
University of San Diego Medical Center
San Diego, California, 92103
University of California San Francisco
San Francisco, California, 94143
Virginia Mason Medical Center
Seattle, Washington, 98101
University of Washington
Seattle, Washington, 98103
St. Louis University
St Louis, Missouri, 63104
University of Arizona Health Sciences Center
Tucson, Arizona, 85724
Canada6 sites
University of Calgary
Calgary, Alberta, T2N 4Z6
University of Alberta
Edmonton, Alberta, T6G 2X8
Dalhousie University
Halifax, Nova Scotia, B3H 2Y9
London Health Science Center
London, Ontario, N6C 5A5
Toronto Liver Centre
Toronto, Ontario, M6H 3M1
University of Manitoba
Winnepeg, Manitoba, R3E 3P4
United Kingdom6 sites
New Queen Elizabeth Hospital
Birmingham, B15 2WB
John Radcliffe Hospital
Headington, OX3 9DU
Imperial College Healthcare NHS Trust- St. Mary's Hospital
London, W2 1NY
University College London
London, WC1E 6HX
Norfolk and Norwich University Hospital
Norwich, NR4 7UY
University of Nottingham
Nottingham, NG7 2UH
Belgium5 sites
Hôpital Erasme
Brussels, 1070
Université Catholique de Louvain
Brussels, 1200
UZ Antwerpen
Edegem, 2650
UZ Gent
Ghent, B-9000
UZ Leuven
Leuven, 3000
Germany4 sites
Klinikum der Johann Wolfgang Goethe Universitat
Frankfurt, 60590
Medizinische Hochschule Hannover
Hanover, 30625
Gastroenterologisch Hepatologisches Zentrum Kiel
Kiel, 24146
EUGASTRO GmbH
Leipzig, 4103
Denmark3 sites
Århus Universitetshospital, Århus Sygehus
Århus C, DK-8000
Hvidovre Hospital
Hvidovre, DK-2650
Rigshospitalet
København Ø, DK-2100
Italy3 sites
Azienda Ospedaliera San Camillo Forlanini
Roma, 144
Istituto Clinico Humanitas
Rozzano, Milano, 20089
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, 10126
Spain3 sites
Hospital Universitario Vall d'Hebron
Barcelona, Catalonia, 8035
Hospital Donostia
Donostia / San Sebastian, 20080
Hospital Universitario Puerta de Hierro
Majadahonda, 28222
About this study
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 2 (LOXL2) in Subjects With Primary Sclerosing Cholangitis (PSC)
The purpose of this study is to evaluate whether simtuzumab (GS-6624) is effective at preventing the progression of liver fibrosis in adults with primary sclerosing cholangitis (PSC).
- Conditions
- Primary Sclerosing Cholangitis (PSC)
- Being tested
- Simtuzumab, Placebo
- Keywords
- PSC, Sclerosis, Monoclonal antibody, LOXL2, Simtuzumab, Primary sclerosing cholangitis, Liver fibrosis, Liver disease, MRCP, MRE, Liver biopsy
- Medical subject headings
- Cholangitis, Sclerosing, Sclerosis, Liver Cirrhosis, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimtuzumabBiological
Also called GS-6624
Subcutaneous injections weekly for a total of 96 injections
PlaceboBiological
Subcutaneous injections weekly for a total of 96 injections
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm A | Experimental | Simtuzumab 75 mg for 96 weeks Receives: Biological: Simtuzumab |
| Treatment Arm B | Experimental | Simtuzumab 125 mg for 96 weeks Receives: Biological: Simtuzumab |
| Treatment Arm C | Placebo comparator | Placebo for 96 weeks Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in MQC on Liver Biopsy at Week 96
Measured: Baseline; Week 96
Secondary outcomes (3)
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Measured: First dose date up to Week 96
Study Drug Exposure
The average SIM exposure was summarized.
Measured: First dose date up to Week 96
Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality
A treatment-emergent graded laboratory abnormality was defined as an increase of at least 1 abnormality grade from the predose assessment and occurring after the predose visit and on or before the date of the administration of study drug plus 30 days. The most severe graded abnormality from all tests was counted for each participant [Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe); Grade 4 (life-threatening)].
Measured: First dose date up to Week 96 plus 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study start4 Mar 2013
- Primary completion8 Aug 2016
- Study completion24 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Primary Sclerosing Cholangitis (PSC)Studies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672853
- Sponsor's protocol ID
- GS-US-321-0102
- Other IDs
- 2012-002473-61
- Status last verified
- Oct 2019
- First submitted
- 22 Aug 2012
- Last updated
- 22 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Shea P, Hirschfield G, Shiffman M, McColgan B, Goodman Z, Myers, R, et al. Common variation near glial-derived neurotrophic factor is associated with progression of hepatic collagen content in a genome-wide association study of liver fibrosis phenotypes in patients with primary sclerosing cholangitis. J Hepatol 2017; 66 (1): S4-S5.
Muir A, Goodman Z, Levy C, Janssen H, Montano-Loza A, Bowlus C, et al. Efficacy and safety of simtuzumab for the treatment of primary sclerosing cholangitis: results of a phase 2b, dose-ranging, randomized, placebo-controlled trial. J Hepatol 2017; 66 (1): S73.
Bowlus CL, Patel K, Hirschfield G, Guha I, Chapman R, Chazouilleres O, et al. Prospective validation of the Enhanced Liver Fibrosis test for the prediction of disease progression in a randomized trial of patients with primary sclerosing cholangitis. J Hepatol 2017; 66 (1): S359.
Levy C, Eksteen B, Shiffman M, Janssen H, Montano-Loza A, Ding D, et al. Prospective validation of serum alkaline phosphatase for the prediction of disease progression in a randomized trial of patients with primary sclerosing cholangitis. J Hepatol 2017; 66 (1): S360-S361.
Levy C, Shiffman M, Caldwell S, Luketic V, Invernizzi P, Minuk G, et al. Serum fibroblast growth factor 19, 7α-Hydroxy-4-Cholesten-3-one, and bile acids and their associations with clinical characteristics in primary sclerosing cholangitis. J Hepatol 2017; 66 (1): S361.
French D, Huntzicker EG, Goodman ZD, Shea PR, Ding D, Aguilar Schall, RE, et al. Hepatic expression of lysyl oxidase-like-2 (LOXL2) in primary sclerosing cholangitis (PSC). Hepatol 2016; 64 (1): 194A.
Bowlus CL, Montano-Loza AJ, Invernizzi P, Chazouilleres O, Hirschfield G, Metselaar HJ, et al. Liver stiffness measurement by transient elastography for the prediction of fibrosis in patients with primary sclerosing cholangitis in a randomized trial of simtuzumab. J Hepatol 2016; 64 (2): S434.
Goodman Z, Patel K, Guha I, Hameed B, Kowdley K, Alaparthi L, et al. Correlations between hepatic morphometric collagen content, histologic fibrosis stage, and serum markers in patients with primary sclerosing cholangitis (PSC). J Hepatol 2016; 64 (2): S652-S653.
Muir AJ, Goodman Z, Bowlus CL, Caldwell S, Invernizzi P, Luketic V, et al. Serum lysyl oxidase-like-2 (SLOXL2) levels correlate with disease severity in patients with primary sclerosing cholangitis. J Hepatol 2016; 64 (2): S428.
Shea PR, Eksteen B, Hirschfield GM, Shiffman ML, Janssen HLA, Montano-Loza AJ, et al. Genome-wide association study (GWAS) of liver fibrosis phenotypes in patients with primary sclerosing cholangitis (PSC) reveals common genetic variation influencing serum levels of lysyl oxidase-like-2 (LOXL2). J Hepatol 2016; 64 (2): S180-S182.
Manns MP, Eksteen B, Shiffman ML, Levy C, Kowdley KV, Montano-Loza AJ, et al. Association between elevated serum IgG4 (sIgG4) concentrations and the phenotype of patients with primary sclerosing cholangitis (PSC). Hepatol 2015; 62 (1): 515A.
Bowlus CL, Patel K, Chuha IN, Chapman RW, Chazouilleres O, Chalasani NP, et al. Validation of serum fibrosis marker panels in patients with primary sclerosing cholangitis (PSC) in a randomized trial of simtuzumab. Hepatol 2015; 62 (1): 519A.
French D, Goodman ZD, Huntzicker EG, Newstrom D, Karnik S, Smith V, et al. Expression of matrix metalloproteinase 9 (MMP9) and the apoptosis signal-regulating kinase 1 (ASK1) pathway activation marker, phospho-P38 (p-P38), in primary sclerosing cholangitis (PSC). Hepatol 2015; 62 (1): 523A-524A.
Laschtowitz A, Lindberg EL, Liebhoff AM, Liebig LA, Casar C, Steinmann S, Guillot A, Xu J, Schwinge D, Trauner M, Lohse AW, Bonn S, Hubner N, Schramm C. Liver transcriptome analysis reveals PSC-attributed gene set associated with fibrosis progression. JHEP Rep. 2024 Nov 12;7(3):101267. doi: 10.1016/j.jhepr.2024.101267. eCollection 2025 Mar.
PubMed 39996122Thorburn D, Leeming DJ, Barchuk WT, Wang Y, Lu X, Malkov VA, Ito KL, Bowlus CL, Levy C, Goodman Z, Karsdal MA, Muir AJ, Xu J. Serologic extracellular matrix remodeling markers are related to fibrosis stage and prognosis in a phase 2b trial of simtuzumab in patients with primary sclerosing cholangitis. Hepatol Commun. 2024 Jul 5;8(7):e0467. doi: 10.1097/HC9.0000000000000467. eCollection 2024 Jul 1.
PubMed 38967589
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 2 (LOXL2) in Subjects With Primary Sclerosing Cholangitis (PSC)
- ClinicalTrials.gov ID
- NCT01672853
- Acronym / sponsor ID
- GS-US-321-0102
- Conditions
- Primary Sclerosing Cholangitis (PSC)
- Keywords
- PSC, Sclerosis, Monoclonal antibody, LOXL2, Simtuzumab, Primary sclerosing cholangitis, Liver fibrosis, Liver disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2013 (actual)
- Primary completion
- 8 Aug 2016 (actual)
- Study completion
- 24 Aug 2016 (actual)
- First posted
- 27 Aug 2012 (estimated)
- Results
- Posted 22 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether simtuzumab (GS-6624) is effective at preventing the progression of liver fibrosis in adults with primary sclerosing cholangitis (PSC).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm A | Experimental | Biological: SimtuzumabSimtuzumab 75 mg for 96 weeks |
| Treatment Arm B | Experimental | Biological: SimtuzumabSimtuzumab 125 mg for 96 weeks |
| Treatment Arm C | Placebo comparator | Biological: PlaceboPlacebo for 96 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult Individuals (aged 18-70) with chronic cholestatic liver disease of at least 6 months.
- Liver biopsy consistent with PSC: If a liver biopsy has been performed within 3 months of the screening visit, tissue from that biopsy may be used as the screening biopsy. Slides would be re-cut from the existing tissue block and submitted for central reader assessment. Some individuals with PSC may have a normal liver biopsy, in the event of a normal liver biopsy, the individual must have an abnormal magnetic resonance cholangiopancreatography (MRCP).
- MRCP consistent with PSC: Some individuals with PSC may have a normal MRCP; in the event of a normal MRCP, the individual must have an abnormal liver biopsy.
- Exclusion of other causes of liver disease including viral hepatitis ,alcoholic liver disease,primary biliary cirrhosis and secondary sclerosing cholangitis
- Must have aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 10 x the Central Laboratory Upper Limit of Normal (clULN)
Key exclusion criteria (19 listed)
- Pregnant or breast feeding
- Evidence of hepatic decompensation present, including ascites, episodes of hepatic encephalopathy, variceal bleeding or a prolonged prothrombin time/international normalized ratio (PT/INR)
- Positive for hepatitis C virus (HCV) RNA
- Positive for HBsAg
- Positive for anti-mitochondrial antibody
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SimtuzumabAlso: GS-6624Subcutaneous injections weekly for a total of 96 injections | Biological | Treatment Arm A, Treatment Arm B |
| PlaceboSubcutaneous injections weekly for a total of 96 injections | Biological | Treatment Arm C |
Primary outcome
Change From Baseline in MQC on Liver Biopsy at Week 96
Time frame: Baseline; Week 96
3 secondary outcomes
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time frame: First dose date up to Week 96
Study Drug Exposure
Time frame: First dose date up to Week 96
Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality
Time frame: First dose date up to Week 96 plus 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationShea P, Hirschfield G, Shiffman M, McColgan B, Goodman Z, Myers, R, et al. Common variation near glial-derived neurotrophic factor is associated with progression of hepatic collagen content in a genome-wide association study of liver fibrosis phenotypes in patients with primary sclerosing cholangitis. J Hepatol 2017; 66 (1): S4-S5.
- Results publicationMuir A, Goodman Z, Levy C, Janssen H, Montano-Loza A, Bowlus C, et al. Efficacy and safety of simtuzumab for the treatment of primary sclerosing cholangitis: results of a phase 2b, dose-ranging, randomized, placebo-controlled trial. J Hepatol 2017; 66 (1): S73.
- Results publicationBowlus CL, Patel K, Hirschfield G, Guha I, Chapman R, Chazouilleres O, et al. Prospective validation of the Enhanced Liver Fibrosis test for the prediction of disease progression in a randomized trial of patients with primary sclerosing cholangitis. J Hepatol 2017; 66 (1): S359.
- Results publicationLevy C, Eksteen B, Shiffman M, Janssen H, Montano-Loza A, Ding D, et al. Prospective validation of serum alkaline phosphatase for the prediction of disease progression in a randomized trial of patients with primary sclerosing cholangitis. J Hepatol 2017; 66 (1): S360-S361.
- Results publicationLevy C, Shiffman M, Caldwell S, Luketic V, Invernizzi P, Minuk G, et al. Serum fibroblast growth factor 19, 7α-Hydroxy-4-Cholesten-3-one, and bile acids and their associations with clinical characteristics in primary sclerosing cholangitis. J Hepatol 2017; 66 (1): S361.
- Results publicationFrench D, Huntzicker EG, Goodman ZD, Shea PR, Ding D, Aguilar Schall, RE, et al. Hepatic expression of lysyl oxidase-like-2 (LOXL2) in primary sclerosing cholangitis (PSC). Hepatol 2016; 64 (1): 194A.
- Results publicationBowlus CL, Montano-Loza AJ, Invernizzi P, Chazouilleres O, Hirschfield G, Metselaar HJ, et al. Liver stiffness measurement by transient elastography for the prediction of fibrosis in patients with primary sclerosing cholangitis in a randomized trial of simtuzumab. J Hepatol 2016; 64 (2): S434.
- Results publicationGoodman Z, Patel K, Guha I, Hameed B, Kowdley K, Alaparthi L, et al. Correlations between hepatic morphometric collagen content, histologic fibrosis stage, and serum markers in patients with primary sclerosing cholangitis (PSC). J Hepatol 2016; 64 (2): S652-S653.
- Results publicationMuir AJ, Goodman Z, Bowlus CL, Caldwell S, Invernizzi P, Luketic V, et al. Serum lysyl oxidase-like-2 (SLOXL2) levels correlate with disease severity in patients with primary sclerosing cholangitis. J Hepatol 2016; 64 (2): S428.
- Results publicationShea PR, Eksteen B, Hirschfield GM, Shiffman ML, Janssen HLA, Montano-Loza AJ, et al. Genome-wide association study (GWAS) of liver fibrosis phenotypes in patients with primary sclerosing cholangitis (PSC) reveals common genetic variation influencing serum levels of lysyl oxidase-like-2 (LOXL2). J Hepatol 2016; 64 (2): S180-S182.
- Results publicationManns MP, Eksteen B, Shiffman ML, Levy C, Kowdley KV, Montano-Loza AJ, et al. Association between elevated serum IgG4 (sIgG4) concentrations and the phenotype of patients with primary sclerosing cholangitis (PSC). Hepatol 2015; 62 (1): 515A.
- Results publicationBowlus CL, Patel K, Chuha IN, Chapman RW, Chazouilleres O, Chalasani NP, et al. Validation of serum fibrosis marker panels in patients with primary sclerosing cholangitis (PSC) in a randomized trial of simtuzumab. Hepatol 2015; 62 (1): 519A.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
75 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Simtuzumab in people with Primary Sclerosing Cholangitis (PSC), run by Gilead Sciences at 75 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in United States, Canada, United Kingdom, Belgium, Germany and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in MQC on Liver Biopsy at Week 96 (time frame: Baseline; Week 96). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01672853, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2019.