Study of INT-747 as Monotherapy in Patients With PBC - Full Text View

Sponsored by:	Intercept Pharmaceuticals
Information provided by:	Intercept Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00570765

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

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) Monotherapy in Patients With Primary Biliary Cirrhosis

Further study details as provided by Intercept Pharmaceuticals:

Primary Outcome Measures:

In patients with primary biliary cirrhosis (PBC), 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), 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:	120
Study Start Date:	November 2007
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

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

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

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

Locations

United States, Texas
Baylor College of Medicine	Recruiting
Houston, Texas, United States, 77030
Contact: Jana Lee, RN, CCRC 832-693-5814 jlee@sleh.com
Principal Investigator: John Vierling, MD, FACP
United States, Virginia
McGuire DVAMC	Recruiting
Richmond, Virginia, United States, 23219
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

More Information

Responsible Party:	Intercept Pharmaceuticals ( David A. Shapiro, MD - Chief Medical Officer )
Study ID Numbers:	747-201
Study First Received:	December 7, 2007
Last Updated:	April 18, 2008
ClinicalTrials.gov Identifier:	NCT00570765
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Biliary cirrhosis
Liver Diseases
Digestive System Diseases
Cholestasis, Intrahepatic
Bile Duct Diseases
Cholestasis

Fibrosis
Biliary Tract Diseases
Liver Cirrhosis
Primary biliary cirrhosis
Liver Cirrhosis, Biliary

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 13, 2009