Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)
NCT ID: NCT00550862
Last Updated: 2024-02-06
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
165 participants
INTERVENTIONAL
2007-10-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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INT-747 10 mg
INT-747 10 mg once daily in combination with URSO for 12 weeks.
INT-747
Once a day (QD) by mouth (PO)
Ursodeoxycholic Acid (URSO)
Stable dose for at least 6 months prior to screening. Dose as prescribed by physician.
INT-747 25 mg
INT-747 25 mg once daily in combination with URSO for 12 weeks.
INT-747
Once a day (QD) by mouth (PO)
Ursodeoxycholic Acid (URSO)
Stable dose for at least 6 months prior to screening. Dose as prescribed by physician.
INT-747 50 mg
INT-747 50 mg once daily in combination with URSO for 12 weeks.
INT-747
Once a day (QD) by mouth (PO)
Ursodeoxycholic Acid (URSO)
Stable dose for at least 6 months prior to screening. Dose as prescribed by physician.
Placebo
Placebo once daily in combination with URSO for 12 weeks.
INT-747
Once a day (QD) by mouth (PO)
Ursodeoxycholic Acid (URSO)
Stable dose for at least 6 months prior to screening. Dose as prescribed by physician.
Placebo
Placebo
Interventions
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INT-747
Once a day (QD) by mouth (PO)
Ursodeoxycholic Acid (URSO)
Stable dose for at least 6 months prior to screening. Dose as prescribed by physician.
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stable dose of ursodeoxycholic acid (URSO, UDCA) for at least 6 months prior to screening.
* Female patients must be postmenopausal, surgically sterile, or prepared to use 2 methods of contraception with all sexual partners during the study and for 14 days after the end of dosing.
* Male patients must be prepared to use 2 methods of contraception with all sexual partners during the study and for 14 days after the end of the dosing.
* Proven or likely PBC, as demonstrated by the patient presenting with at least 2 of the following 3 diagnostic factors:
1. History of increased AP levels for at least 6 months prior to Day 0
2. Positive AMA titer (\>1:40 titer on immunofluorescence or M2 positive by ELISA) or PBC-specific antinuclear antibodies (antinuclear dot and nuclear rim positive)
3. Liver biopsy consistent with PBC.
* Screening AP value between 1.5 and 10 × ULN.
Exclusion Criteria
* Screening conjugated (direct) bilirubin \>2 × ULN.
* Screening ALT or AST \>5 × ULN.
* Screening serum creatinine \>1.5 mg/dL (133 mol/L).
* History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy, or poorly controlled ascites).
* History or presence of other concomitant liver diseases including hepatitis due to hepatitis B or C virus (HCV, HBV) infection, primary sclerosing cholangitis (PSC), alcoholic liver disease, definite autoimmune liver disease or biopsy proven nonalcoholic steatohepatitis (NASH).
* Pregnancy.
18 Years
70 Years
ALL
No
Sponsors
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Intercept Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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David A Shapiro, MD
Role: STUDY_DIRECTOR
Intercept Pharmaceuticals - Chief Medical Officer
Locations
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U Florida Hepatology
Gainesville, Florida, United States
University of Miami - Center for Liver Diseases
Miami, Florida, United States
Tufts Medical Center
Boston, Massachusetts, United States
Henry Ford Health Center Columbus
Novi, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Saint Louis University
St Louis, Missouri, United States
Beth Israel Medical Center
New York, New York, United States
Mt. Sinai School of Medicine
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
McGuire DVAMC
Richmond, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Karls-Franzens University
Graz, , Austria
University of Calgary
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
University of Manitoba
Winnipeg, Manitoba, Canada
University of Toronto Western Hospital
Toronto, Ontario, Canada
Centre de Recherche du CHUM / University of Montreal
Montreal, Quebec, Canada
Hopital de l'Hotel Dieu
Lyon, , France
Johann Wolfgang Goethe University
Frankfurt, , Germany
University Medical Centre Hamburg-Eppendorf
Hamburg, , Germany
Medical School of Hannover
Hanover, , Germany
University of Munich
Munich, , Germany
AMC University of Amsterdam
Amsterdam, , Netherlands
Erasmus Medical Centre
Rotterdam, , Netherlands
Hospital Clinic i Provincial
Barcelona, , Spain
Queen Elizabeth Medical Center
Edgbaston, Birmingham, United Kingdom
Royal Free Hospital
Hampstead, London, United Kingdom
John Radcliffe Hospital
Headington, Oxford, United Kingdom
Royal Infirmary
Edinburgh, , United Kingdom
University Upon Tyne/Newcastle
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Hirschfield GM, Mason A, Luketic V, Lindor K, Gordon SC, Mayo M, Kowdley KV, Vincent C, Bodhenheimer HC Jr, Pares A, Trauner M, Marschall HU, Adorini L, Sciacca C, Beecher-Jones T, Castelloe E, Bohm O, Shapiro D. Efficacy of obeticholic acid in patients with primary biliary cirrhosis and inadequate response to ursodeoxycholic acid. Gastroenterology. 2015 Apr;148(4):751-61.e8. doi: 10.1053/j.gastro.2014.12.005. Epub 2014 Dec 11.
Other Identifiers
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747-202
Identifier Type: -
Identifier Source: org_study_id
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