Primary Sclerosing Cholangitis Clinical Trial
Official title:
A Phase 2, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects With Primary Sclerosing Cholangitis Without Cirrhosis
Verified date | May 2021 |
Source | Gilead Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of this study is to evaluate the safety and tolerability of cilofexor in adults with primary sclerosing cholangitis (PSC).
Status | Completed |
Enrollment | 52 |
Est. completion date | May 18, 2020 |
Est. primary completion date | February 28, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Key Inclusion Criteria: - Diagnosis of PSC based on cholangiogram (magnetic resonance cholangiopancreatography (MRCP), endoscopic retrograde cholangiopancreatography (ERCP), or percutaneous transhepatic cholangiogram (PTC)) within the previous 12 months - Serum alkaline phosphatase (ALP) > 1.67 x upper limit of the normal range (ULN) - For individuals on ursodeoxycholic acid (UDCA), the dose of UDCA must have been stable for at least 12 months prior to screening through the end of treatment. For individuals not on UDCA, no UDCA use for at least 12 months before screening through the end of treatment - For individuals being administered biologic treatments (eg, antitumor necrosis factor (TNF) or anti-integrin monoclonal antibodies), immunosuppressants or systemic corticosteroids, the dose must have been stable at least 3 months prior to screening and anticipated to remain stable throughout the trial - Screening FibroSURE/FibroTest® <0.75 unless a historical liver biopsy within 12 months of screening does not reveal cirrhosis. In adults with Gilbert's syndrome or hemolysis, FibroSURE/FibroTest® will be calculated using direct bilirubin instead of total bilirubin. Key Exclusion Criteria: - Alanine aminotransferase (ALT) > 10 x ULN - Total bilirubin > 2 x ULN - International normalized ratio (INR) > 1.2 unless on anticoagulant therapy - Small-duct PSC (histologic evidence of PSC with normal bile ducts on cholangiography) - Other causes of liver disease including secondary sclerosing cholangitis and viral, metabolic, alcoholic, and other autoimmune conditions. Individuals with hepatic steatosis may be included if there is no evidence of nonalcoholic steatohepatitis (NASH) in the opinion of the investigator or on liver biopsy; - Ascending cholangitis within 60 days of screening - Presence of a percutaneous drain or bile duct stent - Use of fibrates or obeticholic acid within 3 months prior to screening through the end of treatment - Cirrhosis of the liver as defined by any of the following: - Historical liver biopsy demonstrating cirrhosis (eg, Ludwig stage 4 or Ishak stage = 5) - Prior history of decompensated liver disease, including ascites, hepatic encephalopathy or variceal bleeding - Liver stiffness > 14.4 kilopascal (kPa) by FibroScan - Current, active inflammatory bowel disease (IBD) defined as a partial Mayo score of > 1 and/or a score on the Rectal Bleeding domain > 0. Note: Other protocol defined Inclusion/Exclusion criteria may apply. |
Country | Name | City | State |
---|---|---|---|
Austria | Universitätsklinik Klinik für Innere Medizin III | Vienna | |
Canada | University of Calgary Liver Unit (Heritage Medical Research Clinic) | Calgary | Alberta |
Canada | Toronto Liver Centre | Toronto | Ontario |
United Kingdom | New Queen Elizabeth Hospital NHS Foundation Trust | Birmingham | |
United Kingdom | King's College Hospital NHS Foundation Trust | London | |
United Kingdom | Royal Free Hospital | London | |
United Kingdom | Norfolk and Norwich University Hospital | Norwich | |
United States | University of Colorado Denver | Aurora | Colorado |
United States | University of Virginia | Charlottesville | Virginia |
United States | The Liver Institute at Methodist Dallas Medical Center | Dallas | Texas |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Indiana University Health University Hospital | Indianapolis | Indiana |
United States | Florida Digestive Health Specialists | Lakewood Ranch | Florida |
United States | Schiff Center for Liver Diseases/University of Miami | Miami | Florida |
United States | Intermountain Medical Center - Transplant Services | Murray | Utah |
United States | Bon Secours St. Mary's Hospital of Richmond, Inc. | Richmond | Virginia |
United States | McGuire VA Medical Center | Richmond | Virginia |
United States | Virginia Commonwealth University | Richmond | Virginia |
United States | University of California, Davis Medical Center | Sacramento | California |
United States | Minnesota Gastroenterology, P.A. | Saint Paul | Minnesota |
United States | University of California San Francisco | San Francisco | California |
United States | Swedish Organ Transplant and Liver Center | Seattle | Washington |
United States | University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Gilead Sciences |
United States, Austria, Canada, United Kingdom,
Trauner M, Gulamhusein A, Hameed B, Caldwell S, Shiffman ML, Landis C, Eksteen B, Agarwal K, Muir A, Rushbrook S, Lu X, Xu J, Chuang JC, Billin AN, Li G, Chung C, Subramanian GM, Myers RP, Bowlus CL, Kowdley KV. The Nonsteroidal Farnesoid X Receptor Agoni — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants Experiencing Treatment-Emergent Adverse Events During the Blinded Phase | Treatment-emergent adverse events occurring during the Blinded Phase were defined as 1 or both of the following: 1) Any adverse events (AEs) with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug in the Blinded Phase (and before the first dosing date in the Open Label Extension (OLE) Phase), or 2) Any AEs leading to premature discontinuation of study drug in the Blinded Phase. | First dose date up to last dose date plus 30 days (Up to 17 weeks) | |
Primary | Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events During the Blinded Phase | A serious adverse event was defined as an event that, at any dose, resulted in any of the following: death, life-threatening, in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, or a medically important event or reaction. | First dose date up to last dose date plus 30 days (Up to 17 weeks) | |
Primary | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities During the Blinded Phase | Treatment-emergent laboratory abnormalities occurring during the Blinded Phase were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug in the Blinded Phase plus 30 days (and prior to or on the first dose date of the OLE phase). The Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 was used for assigning toxicity grades (0 to 4, with higher grades indicating more severity). | First dose date up to last dose date plus 30 days (Up to 17 weeks) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02239211 -
A Trial of BTT1023 in Patients With Primary Sclerosing Cholangitis
|
Phase 2 | |
Withdrawn |
NCT03216876 -
A Study Of Ursolic Acid For Primary Sclerosing Cholangitis
|
Phase 1 | |
Recruiting |
NCT02605213 -
Effect and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis Patients
|
Phase 4 | |
Recruiting |
NCT01688024 -
Mitomycin C Therapy for Patients With Primary Sclerosing Cholangitis
|
Phase 2 | |
Completed |
NCT03041662 -
Surveillance Study for Early Detection of Cholangiocarcinoma (CCA) in Primary Sclerosing Cholangitis (PSC)
|
||
Completed |
NCT05866809 -
Evaluation of the Safety and Efficacy of HK-660S in Patients With Primary Sclerosing Cholangitis
|
Phase 2 | |
Recruiting |
NCT05618145 -
National Database on Primary Sclerosing Cholangitis (PSC)
|
||
Active, not recruiting |
NCT02446665 -
Disease Status in Primary Sclerosing Cholangitis by Elastography
|
N/A | |
Completed |
NCT02247934 -
Development of a Patient-Reported Outcome Measure to Assess Symptoms in Patients With Primary Sclerosing Cholangitis (PSC)
|
N/A | |
Terminated |
NCT01142323 -
Pilot Study of Fenofibrate for PSC
|
Phase 1/Phase 2 | |
Completed |
NCT01088607 -
Safety and Efficacy Study of Ursodeoxycholic Acid Therapy in Pediatric Primary Sclerosing Cholangitis
|
Phase 1 | |
Terminated |
NCT04060147 -
Safety and Tolerability of Cilofexor in Participants With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis
|
Phase 1 | |
Recruiting |
NCT04133792 -
Effect of Simvastatin on the Prognosis of Primary Primary Sclerosing Cholangitis (PSC)
|
Phase 3 | |
Active, not recruiting |
NCT04595825 -
CM-101 in PSC Patients -The SPRING Study
|
Phase 2 | |
Recruiting |
NCT03183570 -
Detection of Integrin avb6 in IPF, PSC, and COVID19 Using PET/CT
|
Early Phase 1 | |
Completed |
NCT00951327 -
Cholangioscopy Using Narrow Band Imaging (NBI) in Patients With Primary Sclerosing Cholangitis (PSC) Undergoing Endoscopic Retrograde Cholangiopancreatogram (ERCP)
|
N/A | |
Completed |
NCT04024813 -
A Study to Evaluate the Safety, and Tolerability, and Efficacy of Seladelpar in Patients With PSC
|
Phase 2 | |
Recruiting |
NCT05912387 -
Statin Therapy in Primary Sclerosing Cholangitis (PSC): a Multi-omics Study
|
Early Phase 1 | |
Completed |
NCT02884557 -
NKT Role in the Regulation of the Inflammatory Bowel Disease
|
N/A | |
Recruiting |
NCT01398917 -
Short-term Stenting Versus Balloon Dilatation for Dominant Strictures in Primary Sclerosing Cholangitis
|
Phase 3 |