Study of INT-747 as Monotherapy in Participants With Primary Biliary Cirrhosis (PBC)

Completed · Phase 2 · Has a placebo group

Conditions studied: Liver Cirrhosis, Biliary

In brief

The primary hypothesis was that obeticholic acid (OCA) will cause a reduction in alkaline phosphatase levels in PBC participants, over a 12-week treatment period, as compared to placebo.

Key facts

Study ID

NCT00570765

Run by

Intercept Pharmaceuticals

People needed

60

Starts

2008-01-17

Expected to finish

2017-09-25

Last updated by the study team

2021-06-22

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Female participants must be postmenopausal, surgically sterile, or if premenopausal, be prepared to use 1 effective method of contraception with all sexual partners during the study and for 14 days after the end of dosing.
• Male participants must be prepared to use 1 effective method of contraception with all sexual partners during the study during the study unless they had a prior vasectomy.
• Proven or likely PBC, as demonstrated by the participant presenting with at least 2 of the following 3 diagnostic factors:
• History of increased alkaline phosphatase (ALP) levels for at least 6 months;
• Positive antimitochondrial antibody titer (>1:40 titer on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay) or PBC-specific antinuclear antibodies (antinuclear dot and nuclear rim positive);
• Liver biopsy consistent with PBC
• Screening ALP level between 1.5 and 10 × upper limit of normal (ULN).

You may not qualify if…

• Administration of the following drugs at any time during the 3 months prior to screening for the study: ursodeoxycholic acid, colchicine, methotrexate, azathioprine, or systemic corticosteroids.
• Screening conjugated (direct) bilirubin >2 × ULN.
• Screening alanine aminotransferase or aspartate aminotransferase >5 × ULN.
• Screening serum creatinine >133 micromoles/liter (1.5 mg/deciliter).
• History or presence of hepatic decompensation (for example, variceal bleeds, encephalopathy, or poorly controlled ascites).
• History or presence of other concomitant liver diseases including hepatitis due to hepatitis B or C virus infection, primary sclerosing cholangitis, alcoholic liver disease, definite autoimmune liver disease or biopsy proven nonalcoholic steatohepatitis.
• Pregnancy.

Where it is running

• Henry Ford — Detroit, Michigan, United States
• Baylor College of Medicine — Houston, Texas, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• Karls-Franzens University — Graz, Austria
• University of Alberta — Edmonton, Alberta, Canada
• University of Toronto — Toronto, Ontario, Canada
• Centre de Recherche du CHUM / University of Montreal — Montreal, Quebec, Canada
• Hopital de l'Hotel Dieu — Lyon, France
• Hopital Saint-Antoine — Paris, 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
• 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
• Sunderland Research Ethics Committee — Jarrow, United Kingdom
• University Upon Tyne/Newcastle — Newcastle upon Tyne, United Kingdom

Full record on ClinicalTrials.gov

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