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Study of INT-747 as Monotherapy in Patients With PBC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00570765
Recruitment Status : Completed
First Posted : December 11, 2007
Results First Posted : July 7, 2011
Last Update Posted : April 3, 2018
Information provided by (Responsible Party):
Intercept Pharmaceuticals

Brief Summary:
The primary hypothesis is that INT 747 will cause a reduction in alkaline phosphatase levels in PBC patients, over a 12 week treatment period, as compared to placebo.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis, Biliary Drug: Placebo Drug: INT-747 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Study of INT-747 (6-ECDCA) Monotherapy in Patients With Primary Biliary Cirrhosis
Study Start Date : November 2007
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Arm Intervention/treatment
Experimental: 10 mg PO QD Drug: INT-747
10 mg po qd

Experimental: 50 mg PO QD Drug: INT-747
50 mg po qd

Placebo Comparator: Placebo PO QD Drug: Placebo

Primary Outcome Measures :
  1. Alkaline Phosphatase (AP) Levels [ Time Frame: Baseline and 12 weeks ]
    Percent (%) Change in Serum Alkaline Phosphatase from baseline to end of study (EOS)at Day 85.

Secondary Outcome Measures :
  1. Hepatocellular Injury and Liver Function: GGT [ Time Frame: Baeline and 12 weeks ]
    Percent change of gamma-glutamyl transferase (GGT)from Baseline (Day 0) vs. Day 85/ or early termination (ET) visit.

  2. Hepatocellular Injury and Liver Function: ALT [ Time Frame: Baeline and 12 weeks ]
    Percent change of alanine transaminase(ALT)from Baseline (Day 0) vs. Day 85/ or early termination.

  3. Plasma Trough Concentrations of INT-747 and Its Major, Known Metabolites [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female age 18 to 70 years.
  • 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:
  • History of increased AP levels for at least 6 months prior to Day 0
  • Positive AMA titer (>1:40 titer on immunofluorescence or M2 positive by ELISA) or PBC-specific antinuclear antibodies (antinuclear dot and nuclear rim positive)
  • Liver biopsy consistent with PBC
  • Screening AP value between 1.5 and 10 × ULN

Exclusion Criteria:

  • Administration of the following drugs at any time during the 3 months prior to screening for the study: ursodeoxycholic acid (UDCA, URSO®), colchicine, methotrexate, azathioprine, or systemic corticosteroids.
  • Screening conjugated (direct) bilirubin >2 × ULN.
  • Screening ALT or AST >5 × ULN.
  • Screening serum creatinine >133 μmol/L (1.5 mg/dL). 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00570765

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United States, Michigan
Henry Ford
Novi, Michigan, United States, 39450
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Virginia
Richmond, Virginia, United States, 23219
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Karls-Franzens University
Graz, Austria, A8036
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2C8
Canada, Ontario
University of Toronto
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
Centre de Recherche du CHUM / University of Montreal
Montreal, Quebec, Canada, H2X 1P1
Hopital de l'Hotel Dieu
Lyon, France, 69288
Hopital Saint-Antoine
Paris, France, 75012
Johann Wolfgang Goethe University
Frankfurt, Germany, 60590
University Medical Centre Hamburg-Eppendorf
Hamburg, Germany, D20246
Medical School of Hannover
Hannover, Germany, 30623
University of Munich
Munich, Germany, D81377
Hospital Clinic i Provincial
Barcelona, Spain, 08036
United Kingdom
Queen Elizabeth Medical Center
Edgbaston, Birmingham, United Kingdom, B15 2TH
Royal Free Hospital
Hampstead, London, United Kingdom, NW3 2QG
John Radcliffe Hospital
Headington, Oxford, United Kingdom, OX3 9DU
Royal Infirmary
Edinburgh, United Kingdom, EH16 4SA
University Upon Tyne/Newcastle
Newcastle Upon Tyne, United Kingdom, NE2 4HH
Sponsors and Collaborators
Intercept Pharmaceuticals
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Study Director: David A Shapiro, MD Intercept Pharmaceuticals

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Responsible Party: Intercept Pharmaceuticals Identifier: NCT00570765     History of Changes
Other Study ID Numbers: 747-201
First Posted: December 11, 2007    Key Record Dates
Results First Posted: July 7, 2011
Last Update Posted: April 3, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Cirrhosis, Biliary
Pathologic Processes
Liver Diseases
Digestive System Diseases
Cholestasis, Intrahepatic
Bile Duct Diseases
Biliary Tract Diseases
Chenodeoxycholic Acid
Gastrointestinal Agents