Study of INT-747 as Monotherapy in Patients With PBC

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intercept Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00570765
First received: December 7, 2007
Last updated: January 9, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Liver Cirrhosis, Biliary
Drug: Placebo
Drug: INT-747
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Study of INT-747 (6-ECDCA) Monotherapy in Patients With Primary Biliary Cirrhosis

Resource links provided by NLM:


Further study details as provided by Intercept Pharmaceuticals:

Primary Outcome Measures:
  • Alkaline Phosphatase (AP) Levels [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Percent (%) Change in Serum Alkaline Phosphatase from baseline to end of study (EOS)at Day 85.


Secondary Outcome Measures:
  • Hepatocellular Injury and Liver Function: GGT [ Time Frame: Baeline and 12 weeks ] [ Designated as safety issue: No ]
    Percent change of gamma-glutamyl transferase (GGT)from Baseline (Day 0) vs. Day 85/ or early termination (ET) visit.

  • Hepatocellular Injury and Liver Function: ALT [ Time Frame: Baeline and 12 weeks ] [ Designated as safety issue: No ]
    Percent change of alanine transaminase(ALT)from Baseline (Day 0) vs. Day 85/ or early termination.

  • Plasma Trough Concentrations of INT-747 and Its Major, Known Metabolites [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: November 2007
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00570765

Locations
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
McGuire DVAMC
Richmond, Virginia, United States, 23219
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Austria
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
France
Hopital de l'Hotel Dieu
Lyon, France, 69288
Hopital Saint-Antoine
Paris, France, 75012
Germany
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
Spain
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
Investigators
Study Director: David A Shapiro, MD Intercept Pharmaceuticals
  More Information

No publications provided

Responsible Party: Intercept Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00570765     History of Changes
Other Study ID Numbers: 747-201
Study First Received: December 7, 2007
Results First Received: June 9, 2011
Last Updated: January 9, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Liver Cirrhosis, Biliary
Liver Cirrhosis
Fibrosis
Cholestasis, Intrahepatic
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Liver Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014