Study of INT 747 in Combination With URSO in Patients With PBC - Full Text View

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: INT-747	Phase II

MedlinePlus related topics:

Cirrhosis

ChemIDplus related topics:

Ursodeoxycholic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Study of INT 747 (6-ECDCA) in Combination With Ursodeoxycholic Acid (URSO®, UDCA) in Patients With Primary Biliary Cirrhosis

Further study details as provided by Intercept Pharmaceuticals:

Primary Outcome Measures:

In patients with primary biliary cirrhosis (PBC) taking UDCA, to assess the effects of INT-747 on both 1) alkaline phosphatase (AP) levels and 2) safety [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

In patients with primary biliary cirrhosis (PBC) taking UDCA, to assess the effects of INT-747 on 1) hepatocellular injury and liver function, 2) disease-specific and general health symptoms and 3) biomarkers of hepatic inflammation and fibrosis. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Plasma trough concentrations of INT-747 and its major, known metabolites [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	140
Study Start Date:	October 2007
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
10 mg: Experimental	Drug: INT-747 PO QD
25 mg: Experimental	Drug: INT-747 PO QD
50 mg: Experimental	Drug: INT-747 PO QD
Placebo: Placebo Comparator	Drug: INT-747 PO QD

Detailed Description:

None provided

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.
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:

Administration of the following drugs at any time during the 3 months prior to screening for the study: colchicine, methotrexate, azathioprine, or systemic corticosteroids.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00550862

Locations


United States, Florida
	University of Miami - Center for Liver Diseases	Recruiting
	Miami, Florida, United States, 33136
	Contact: Carlos Quintero 305-243-2854 CQuintero@med.miami.edu
	Principal Investigator: Flavia Mendes, MD

United States, Minnesota
	Mayo Clinic	Recruiting
	Rochester, Minnesota, United States, 59905
	Contact: Jill Keach 507-538-0678 keach.jill@mayo.edu
	Principal Investigator: Keith Lindor, MD

United States, New York
	Beth Israel	Recruiting
	New York, New York, United States, 10003
	Contact: Ivanka Zic, RN, MSN 212-844-6408 izic@chpnet.org
	Principal Investigator: Henry Bodenheimer, MD

United States, Ohio
	Cleveland Clinic	Recruiting
	Cleveland, Ohio, United States, 44195
	Contact: Ruth Sargent 216-444-3126 sargenr@ccf.org
	Principal Investigator: Arthur J McCullough, MD

United States, Texas
	University Texas Southwestern	Recruiting
	Dallas, Texas, United States, 75390
	Contact: Shana Elman, MA, MS-4 214-645-6453 shana.elman@utsouthwestern.edu
	Principal Investigator: Marlyn Mayo, MD
	Baylor College of Medicine	Recruiting
	Houston, Texas, United States, 77030
	Contact: Jana Lee, RN, CCRN 832-693-5814 jlee@sleh.com
	Principal Investigator: John Vierling, MD, FACP

United States, Virginia
	McGuire DVAMC	Recruiting
	Richmond, Virginia, United States, 23249
	Contact: Denice Shelton, RN 804-675-5000 ext 3686 denice.shelton@med.va.gov
	Principal Investigator: Velimir Luketic, MD

Sponsors and Collaborators

Intercept Pharmaceuticals

Investigators


Study Director:	David A Shapiro, MD	Intercept Pharmaceuticals - Chief Medical Officer

More Information

Responsible Party:	Intercept Pharmaceuticals ( David A. Shapiro, MD - Chief Medical Officer )
Study ID Numbers:	747-202
First Received:	October 27, 2007
Last Updated:	April 18, 2008
ClinicalTrials.gov Identifier:	NCT00550862
Health Authority:	United States: Food and Drug Administration