Study Stopped
The DMC made the recommendation to not pursue further enrollment given the lack of feasibility for this post-marketing study as designed.
Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis
COBALT
A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Patients With Primary Biliary Cholangitis
1 other identifier
interventional
334
28 countries
163
Brief Summary
Primary Biliary Cholangitis (PBC) is a serious, life-threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver transplantation or resulting in death. The investigational drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist that is derived from the primary human bile acid chenodeoxycholic acid. The key mechanisms of action of OCA, including its choleretic, anti-inflammatory, and anti-fibrotic properties, underlie its hepatoprotective effects and result in attenuation of injury and improved liver function in a cholestatic liver disease such as PBC. The study will assess the effect of OCA compared to placebo, combined with stable standard care, on clinical outcomes in PBC participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2014
Longer than P75 for phase_4
163 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2014
CompletedFirst Posted
Study publicly available on registry
December 4, 2014
CompletedStudy Start
First participant enrolled
December 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 23, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 23, 2021
CompletedResults Posted
Study results publicly available
March 9, 2023
CompletedMarch 9, 2023
February 1, 2023
7 years
November 10, 2014
December 20, 2022
February 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Time to the First Occurrence of Composite Endpoint
To assess the effect of OCA, compared to placebo in conjunction with the established local standard of care, on clinical outcomes in participants with PBC as measured by time to the first occurrence of any of the following adjudicated events, derived as a composite event endpoint of death, liver transplant, model of end-stage liver disease (MELD) ≥15, uncontrolled ascites, or hospitalization for new onset or recurrence of variceal bleed, hepatic encephalopathy (as defined by a West Haven score of \>=2), or spontaneous bacterial peritonitis. The clinical events distribution was estimated using the Kaplan-Meier methodology. Point estimates and 95% confidence intervals (CIs) for the clinical events distribution percentiles (25th and 50th) are provided.
Time to first occurrence from date of randomization until the time to accrue approximately 127 primary endpoint events (up to 7 years)
Time to the First Occurrence of Primary Clinical Event (Expanded Endpoint)
Primary clinical outcome event is the first occurrence of the following events: death, liver transplant, MELD score \>=15 (MELD-Na score \>=12 baseline), MELD-Na score \>=15 (MELD-Na score \<12 baseline), hospitalization for new onset or recurrence of variceal bleed, hepatic encephalopathy, spontaneous bacterial peritonitis (confirmed by diagnostic paracentesis), or bacterial empyema, uncontrolled or refractory ascites (requiring large volume paracentesis), portal hypertension syndromes, progression to decompensated liver disease, and progression to clinical evidence of portal hypertension without decompensation (for participants without decompensation or clinical evidence of portal hypertension at baseline). 71 endpoint events were observed in the OCA arm, and 80 were observed in the Placebo arm. The clinical events distribution was estimated using the Kaplan-Meier methodology. Point estimates and 95% CIs for the clinical events distribution percentiles (25th and 50th) are provided.
Time to first occurrence from date of randomization until the time to accrue approximately 127 primary endpoint events (up to 7 years)
Secondary Outcomes (134)
Time To First Occurrence Of Severe Decompensating Events of Expanded Composite Endpoint
Time to first occurrence from date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up to 7 years)
Time To Liver Transplant Or Death (All-cause)
Time to first occurrence from date of randomization until the date of first documented liver transplant or date of death from any cause (up to 7 years)
Time to First Occurrence of Fatal Event (All-Cause)
Time to first occurrence from date of randomization until the date of death from any cause (up to 7 years)
Time to First Occurrence of Liver Transplant
Time to first occurrence from date of randomization until the date of first documented liver transplant or date of death from any cause (up to 5 years)
Time to First Occurrence of Hospitalization Due to Hepatic Events
Time to first occurrence from date of randomization until the date of hospitalization, liver transplant or death from any cause, whichever came first (up to 5 years)
- +129 more secondary outcomes
Study Arms (2)
Obeticholic Acid (OCA) 5 mg to 10 mg
EXPERIMENTALObeticholic Acid (OCA) 5 mg for a minimum 3 months and then titrating up to a maximum 10 mg for the remainder of the trial (based on tolerability and CP Score).
Placebo
PLACEBO COMPARATORInterventions
Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, subsequently titrating up to a maximum dose and frequency of 10 mg OCA twice weekly based on tolerability and biochemical response for the duration of the study.
One tablet daily (or a lower frequency depending on CP score) for the remainder of the study
Eligibility Criteria
You may qualify if:
- Definite or probable PBC diagnosis (consistent with American Association for the Study of Liver Diseases \[AASLD\] and the European Association for the Study of the Liver \[EASL\] practice guidelines; Lindor 2009; EASL 2009), as demonstrated by the presence of ≥2 of the following 3 diagnostic factors:
- History of elevated Alkaline phosphatase levels for at least 6 months
- Positive antimitochondrial antibody (AMA) titer or if AMA negative or in low titer (\<1:80) PBC-specific antibodies (anti-GP210 and/or anti-SP100 and/or antibodies against the major M2 components \[PDC-E2, 2-oxo-glutaric acid dehydrogenase complex\])
- Liver biopsy consistent with PBC
- A mean total bilirubin \>ULN and ≤5x ULN and/or a mean ALP \>3x ULN
- Either is not taking UDCA (no UDCA dose in the past 3 months) or has been taking UDCA for at least 12 months with a stable dose for ≥3 months prior to Day 0
You may not qualify if:
- History or presence of other concomitant liver diseases including:
- Hepatitis C virus infection
- Active Hepatitis B infection; however, subjects who have seroconverted (hepatitis B surface antigen and hepatitis B e antigen negative) may be included in this study after consultation with the medical monitor
- Primary sclerosing cholangitis (PSC)
- Alcoholic liver disease
- Definite autoimmune liver disease or overlap hepatitis
- Nonalcoholic steatohepatitis (NASH)
- Gilbert's Syndrome
- Presence of clinical complications of PBC or clinically significant hepatic decompensation, including:
- Cirrhosis with complications, including history (within the past 12 months) or presence of:
- Variceal bleed
- Uncontrolled ascites
- Encephalopathy
- Spontaneous bacterial peritonitis
- Known or suspected HCC
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (181)
Mayo Clinic Arizona
Phoenix, Arizona, 85054, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Inland Empire Liver Foundation
Rialto, California, 92377, United States
University of California Davis, Davis Medical Center
Sacramento, California, 95817, United States
Stanford University
Stanford, California, 94304, United States
University of Colorado Denver and Hospital
Aurora, Colorado, 80045, United States
UF Hepatology Research at CTRB
Gainesville, Florida, 32610, United States
Schiff Center for Liver Diseases/University of Miami
Miami, Florida, 33163, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, 30309, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia, 30060, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60637, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, 46237, United States
University of Louisville, Medical Dental Complex
Louisville, Kentucky, 40202, United States
Tulane University Medical Center
New Orleans, Louisiana, 70112, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
UMass Medical School
Worcester, Massachusetts, 01655, United States
Henry Ford Health System
Novi, Michigan, 48377, United States
Minnesota Gastroenterology, P.A.
Saint Paul, Minnesota, 55114, United States
Southern Therapy and Advanced Research (STAR)
Jackson, Mississippi, 39216, United States
Kansas City Research Institute
Kansas City, Missouri, 64131, United States
Saint Louis University Gastroenterology & Hepatology
St Louis, Missouri, 63104, United States
Saint Joseph's Regional Medical Center
Paterson, New Jersey, 07503, United States
Mount Sinai Beth Israel
New York, New York, 10003, United States
Weill Cornell Medical College
New York, New York, 10021, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Quality Medical Research, PLLC
Nashville, Tennessee, 37211, United States
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, 75203, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Texas Digestive Disease Consultants
Dallas, Texas, 75246, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
Baylor Scott and White Research Institute
Fort Worth, Texas, 76104, United States
Baylor College of Medicine - Advanced Liver Therapies
Houston, Texas, 77030, United States
UT Health The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
American Research Corporation at Texas Liver Institute
San Antonio, Texas, 78215, United States
Texas Digestive Disease Consultants
Southlake, Texas, 76092, United States
Clinical Research Centers of America
Murray, Utah, 84123, United States
McGuire DVAMC
Richmond, Virginia, 23249, United States
Swedish Organ Transplant & Liver Center
Seattle, Washington, 98104, United States
Centro De Hepatología
La Plata, Buenos Aires, B1902AWL, Argentina
Hospital Universitario Austral
Presidente Derqui, Buenos Aires, 1629, Argentina
Dim Clínica Privada
Ramos Mejía, Buenos Aires, 1704, Argentina
Hospital Privado Universitario de Cordoba S.A.
Córdoba, Córdoba Province, X5016KEH, Argentina
Hospital Provincial del Centenario
Rosario, Santa Fe Province, S2002KDS, Argentina
CIPREC - Centro de Investigacion y Prevencion Cardiovascular S.A.
Buenos Aires, 1119, Argentina
Hospital De Clinicas University Of Buenos Aires
Buenos Aires, 1120, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, 1181, Argentina
Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo
Buenos Aires, 1264, Argentina
Centrol Integral de Gastroenterologia
Buenos Aires, 1425, Argentina
Hospital Aleman
Buenos Aires, C1118AAT, Argentina
Hospital Britanico De Buenos Aires
Buenos Aires, C1280AEB, Argentina
AW Morrow Gastroenterology and Liver Centre, Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Department of Gastroenterology & Hepatology, Nepean Hospital
Kingswood, New South Wales, 2747, Australia
Gallipoli Medical Research Foundation
Brisbane, Queensland, 4120, Australia
Department of Gastroenterology and Hepatology, Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Flinders Medical Centre
Adelaide, South Australia, 5042, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065, Australia
Austin Hospital
Heidelberg, Victoria, 3084, Australia
Fiona Stanley Hospital, Gastroenterology Department
Murdoch, Western Australia, 6150, Australia
AKH, Medical University of Vienna
Vienna, 1090, Austria
University Hospital Antwerp
Edegem, Antwerp, 2650, Belgium
Uz Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
Cub Hôpital Erasme
Brussels, 1070, Belgium
University Hospital Ghent
Ghent, 9000, Belgium
Gastrocentro/ Universidade Estadual de Campinas (UNICAMP)
São Paulo, Campinas, 13083-878, Brazil
Instituto Hospital de Base do Distrito Federal-IHBDF
Brasília, Distrito Federal Brazil, 70335-900, Brazil
Hospital Sao Rafael
São Salvador, Estado de Bahia, 41253-190, Brazil
Instituto Goiano de Gastroenterologia
Goiânia, Goiás, 74535-170, Brazil
Cepec Huufma
São Luís, Maranhão, 65020-600, Brazil
Hospital das Clinicas da Universidade Federal de Minas Gerais (UFMG)
Belo Horizonte, Minas Gerais, 30130-100, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Hospital Universitario Professor Edgard Santos
Bahia, Salvador, 40110-060, Brazil
Gastrocentro. Unidad Estadual de CAmpinas UNICAMP
Campinas, São Paulo, 13083-878, Brazil
Universidade Federal do Estado do Rio de Janeiro - Hospital Universitario Gaffree e Guinle/HUGG/UNIRIO
Rio de Janeiro, 20270-004, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo-HCFMUSP
São Paulo, 05403-000, Brazil
St. Ivan Rilsky University Hospital
Sofia, 1431, Bulgaria
University of Calgary Liver Unit (Heritage Medical Research Clinic)
Calgary, Alberta, T2N-4Z6, Canada
University of Alberta, Walter C. Mackenzie Health Sciences Centre (WMC)
Edmonton, Alberta, T6G 2X8, Canada
University Of Manitoba, Health Sciences Centre
Winnipeg, Manitoba, R3E 3P6, Canada
London Health Sciences Centre-University Hospital
London, Ontario, N6A 5A5, Canada
University Health Network, Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Chum
Montreal, Quebec, H2X 3J4, Canada
Centro De Investigaciones Clínicas Viña Del Mar
Viña del Mar, Región de Valparaíso, 2540488, Chile
Aarhus University Hospital Department of Hepatology and Gastroenterology
Aarhus, Aarhus C, 8000, Denmark
Medicinsk klinik for mave, tarm-og leversygdomme
København Ø, 2100, Denmark
Odense University Hospital Afdeling for medicinske mave-tarmsygdomme S
Odense, 5000, Denmark
East Tallinn Central Hospital Gastroenterology Center
Tallinn, Harju, 10138, Estonia
Tartu University Hospital
Tartu, 51014, Estonia
Helsinki University Central Hospital
Helsinki, 00290, Finland
Turku University Central Hospital, Gastroenterology Outpatient Clinic
Turku, 20521, Finland
Hospital Saint-Antoine, A.P.-H.P.
Paris, Paris, 75571, France
CHRU Hôpital HURIEZ
Lille, 59037, France
Chu De Bordeaux - Hôpital Haut Lévêque
Pessac, 33604, France
Klinikum der Johann-Wolfgang Goethe, Universitaet Frankfurt am Main
Frankfurt am Main, Hesse, 60590, Germany
Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie
Hanover, Lower Saxony, D-30625, Germany
Friedrich-Alexander-Uniersitat Erlangen
Erlangen, QLD, 91054, Germany
CHARITÉ, Campus Virchow Klinikum
Berlin, D-13353, Germany
Univeritatsklinikum Hamburg Eppendorf, Medizinische Klinik und Poliklinik
Hamburg, 20246, Germany
Universitaetsklinikum Heidelberg Medizinische Universitaetsklinik
Heidelberg, 69120, Germany
Universität Leipzig KöR, Medizinische Fakultät
Leipzig, 04103, Germany
University of Munich, LMU Klinikum Grosshadern
Munich, 81377, Germany
Queen Mary Hospital
Hong Kong, Pokfulam, Hong Kong
Prince Of Wales Hospital
Hong Kong, Shatin, Hong Kong
Tuen Mun Hospital
Hong Kong, Tuen Mun, New Territories, Hong Kong
Alice Ho Miu Ling Nethersole Hospital
Hong Kong, Hong Kong
Humanity & Health Research Centre
Hong Kong, Hong Kong
Békés Megyei Kozponti Korhaz - Dr. Rethy Pal Tagkorhaz
Békéscsaba, H-5600, Hungary
Szent János Hospital
Budapest, H-1125, Hungary
University Of Debrecen, Department Of Medicine, Division Of Gastroenterology
Debrecen, 4032, Hungary
Hadassah Hebrew University Medical Center
Jerusalem, Nazareth Elit, POB 12000, 91120, Israel
Soroka Medical Center
Beersheba, 84104, Israel
Rambam Health Care Campus
Haifa, 31096, Israel
Shaare Zedek Medical Center
Jerusalem, 91031 02, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
Sheba Medical Center
Ramat Gan, 52656 01, Israel
Sourasky Tel-Aviv Medical Center
Tel Aviv, 64239, Israel
Azienda Ospedaliero - Universitaria di Cagliari - Centro per lo Studio delle Malattie del Fegato
Monserrato, Cagliari, 09042, Italy
Università Politecnica delle Marche - Azienda Ospedaliero
Ancona, 71-60126, Italy
AOU Policlinico Sant' Orsola Malpighi
Bologna, 40138, Italy
Azienda Ospedaliero Universitaria Sant´ Orsola Malpighi
Bologna, 40138, Italy
Azienda Ospedaliero Universitaria Careggi Universita di Firenze
Florence, 50139, Italy
Azienda Socio-Sanitarla Territoriale (ASST) Santi Paolo e Carlo
Milan, 20142, Italy
AOU Ospedale Civile S. Agostino Estense - UO Medicina Metabolica
Modena, 41126, Italy
Azienda Socio Sanitaria Territoriale (ASST) di Monza
Monza, 20900, Italy
Azienda Ospedaliero - Universita di Padova
Padua, 35128, Italy
AOU Policlinico Paolo Giaccone - Di.Bi.M.I.S
Palermo, 90127, Italy
Policlinico Universitario Agostino Gemelli - Universita Cattolica del Sacro Cuore
Rome, 00168, Italy
Hospital of Lithuanian University of Health Sciences, Kauno klinikos
Kaunas, LT 50009, Lithuania
Vilnius University Hospital Santaros klinikos
Vilnius, LT-08661, Lithuania
Departamento De Gastroenterologia. Instituto Nacional De Ciencias Medicas Y Nutricion Salvador Zubiran
Mexico City, Mexico City, 14000, Mexico
Medica Sur, S.A.B. de C.V.
Mexico City, Mexico City, 14050, Mexico
Consultorio Médico de la Dra Alma Laura Ladrón de Guevara Cetina
Mexico City, Mexico City, 6700, Mexico
Radboud UMC
Nijmegen, Gelderland, 6525 GA, Netherlands
Vrije Universiteit Medisch Centrum (VUMC)
Amsterdam, North Holland, 1081HV, Netherlands
Erasmus Mc
Rotterdam, South Holland, 3015 CE, Netherlands
Amsterdam University Medical Centre (AMC)
Amsterdam, 1105 AZ, Netherlands
University Medical Center Utrecht
Utrecht, 3584CX, Netherlands
NZ Liver Transplant Unit, Auckland Hospital
Grafton, Auckland, 1023, New Zealand
Gastroenterology, Christchurch Hospital
Christchurch, Canterbury, 4710, New Zealand
Nzoz Vitamed
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-078, Poland
Wojewodzki Szpital Specjalistyczny im. J. Gromkowskiego, Pierwszy Oddzial Chorob Zakaznych
Wroclaw, Lover Silesia, 51-149, Poland
Centrum Onkologii - Instytut im. Marii Skłodowskiej - Curie, Klinika Gastroenterologii Onkologicznej
Warsaw, Masovian Voivodeship, 02-781, Poland
Medical University of Warsaw Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie (SPCSK in Warsaw
Warsaw, Masovia, 02-097, Poland
Oddział Gastr. I Hepat. Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibińskiego Sum
Katowice, Silesian Voivodeship, 40-752, Poland
Dep. Of Gastroenterology UM Lublin
Lublin, 20-094, Poland
Centro Hospitalar Lisboa Norte, EPE - Hospital de Santa Maria
Lisbon, 1649-035, Portugal
Clinic For Gastroenterology And Hepatology Clinical Center Of Serbia
Belgrade, 11000, Serbia
Clinical Hospital Centre Zvezdara
Belgrade, 11000, Serbia
Inje University Busan Paik Hospital
Busan, Busanjin-gu, 47392, South Korea
Gangnam Severance Hospital
Seoul, Gangnam-gu, 06273, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Seoul National University Hospital
Seoul, Jongno-Gu, 03080, South Korea
Pusan National University Hospital
Busan, Seo-gu, 49241, South Korea
Hospital Universitario Marqués De Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Universitario Puerta De Hierro Majadahonda
Majadahonda, Madrid, 28222, Spain
Hospital Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Virgen De La Victoria University Hospital
Málaga, 29010, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
La Fe, Hospital ( Valence )
Valencia, 46026, Spain
Karolinska University Hospital
Stockholm, Huddinge, 14186, Sweden
Sahlgrenska Universitetssjukhuset
Gothenburg, 413 45, Sweden
Inselspital, University Of Bern, UVCM, DMLL
Bern, 3010, Switzerland
Kantonsspital St. Gallen, Clinic for Gastroeterologie and Hepatologie
Sankt Gallen, 9007, Switzerland
USZ, Klinik für Gastroenterologie und Hepatologie
Zurich, 8091, Switzerland
Ankara University School of Medicine Gastroenterology Dept.
Ankara, 6100, Turkey (Türkiye)
Ege University School of Medicine Gastroenterology Dept.
Izmir, 35100, Turkey (Türkiye)
University Hospitals Bristol NHS Foundation Trust
Bristol, Avon, BS2 8HW, United Kingdom
Plymouth Hospitals NHS Trust, Derriford Hospital
Plymouth, Devon, PL6 8DH, United Kingdom
Gartnavel General Hospital
Glasgow, Lanarkshire, G12 0YN, United Kingdom
Forth Valley Royal Hospital
Larbert, Scotland, FK5 4WR, United Kingdom
Institute of Cellular Medicine
Newcastle upon Tyne, Tyne and Wear, NE2 4HH, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, B15 2GW, United Kingdom
Cambrigde University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ, United Kingdom
The Royal Free Hospital
London, NW3 2QG, United Kingdom
Nottingham University Hospital Nhs Trust
Nottingham, NG7 2UH, United Kingdom
Related Publications (3)
Lindor KD, Gershwin ME, Poupon R, Kaplan M, Bergasa NV, Heathcote EJ; American Association for Study of Liver Diseases. Primary biliary cirrhosis. Hepatology. 2009 Jul;50(1):291-308. doi: 10.1002/hep.22906. No abstract available.
PMID: 19554543BACKGROUNDEuropean Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of cholestatic liver diseases. J Hepatol. 2009 Aug;51(2):237-67. doi: 10.1016/j.jhep.2009.04.009. Epub 2009 Jun 6. No abstract available.
PMID: 19501929BACKGROUNDKowdley KV, Hirschfield GM, Coombs C, Malecha ES, Bessonova L, Li J, Rathnayaka N, Mells G, Jones DE, Trivedi PJ, Hansen BE, Smith R, Wason J, Hiu S, Kareithi DN, Mason AL, Bowlus CL, Muller K, Carbone M, Berenguer M, Milkiewicz P, Adekunle F, Villamil A. COBALT: A Confirmatory Trial of Obeticholic Acid in Primary Biliary Cholangitis With Placebo and External Controls. Am J Gastroenterol. 2025 Feb 1;120(2):390-400. doi: 10.14309/ajg.0000000000003029. Epub 2024 Aug 14.
PMID: 39140490DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The estimated effect of treatment from the ITT population was underpowered and potentially biased, resulting in difficulties in the interpretation of the tests of hypotheses for the primary and key secondary endpoints.
Results Point of Contact
- Title
- Medical Information
- Organization
- Intercept Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Erik Ness, MD
Intercept Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2014
First Posted
December 4, 2014
Study Start
December 26, 2014
Primary Completion
December 23, 2021
Study Completion
December 23, 2021
Last Updated
March 9, 2023
Results First Posted
March 9, 2023
Record last verified: 2023-02