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Trial record 41 of 118 for:    URSODIOL

Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)

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ClinicalTrials.gov Identifier: NCT00550862
Recruitment Status : Completed
First Posted : October 30, 2007
Results First Posted : January 23, 2012
Last Update Posted : February 14, 2012
Sponsor:
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 Primary Biliary Cirrhosis patients, over a 12 week treatment period, as compared to placebo.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis, Biliary Drug: INT-747 Drug: Ursodeoxycholic Acid (URSO) Drug: Placebo Phase 2

Detailed Description:
None provided

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Study of INT 747 (6α-ethyl Chenodeoxycholic Acid (6-ECDCA)) in Combination With Ursodeoxycholic Acid (URSO®, UDCA) in Patients With Primary Biliary Cirrhosis
Study Start Date : October 2007
Primary Completion Date : August 2009
Study Completion Date : December 2010


Arm Intervention/treatment
Experimental: INT-747 10 mg
INT-747 10 mg once daily in combination with URSO for 12 weeks.
Drug: INT-747
Once a day (QD) by mouth (PO)
Other Name: Obeticholic acid (OCA), 6-ECDCA
Drug: Ursodeoxycholic Acid (URSO)
Stable dose for at least 6 months prior to screening. Dose as prescribed by physician.
Other Name: URSO, UDCA
Experimental: INT-747 25 mg
INT-747 25 mg once daily in combination with URSO for 12 weeks.
Drug: INT-747
Once a day (QD) by mouth (PO)
Other Name: Obeticholic acid (OCA), 6-ECDCA
Drug: Ursodeoxycholic Acid (URSO)
Stable dose for at least 6 months prior to screening. Dose as prescribed by physician.
Other Name: URSO, UDCA
Experimental: INT-747 50 mg
INT-747 50 mg once daily in combination with URSO for 12 weeks.
Drug: INT-747
Once a day (QD) by mouth (PO)
Other Name: Obeticholic acid (OCA), 6-ECDCA
Drug: Ursodeoxycholic Acid (URSO)
Stable dose for at least 6 months prior to screening. Dose as prescribed by physician.
Other Name: URSO, UDCA
Placebo Comparator: Placebo
Placebo once daily in combination with URSO for 12 weeks.
Drug: INT-747
Once a day (QD) by mouth (PO)
Other Name: Obeticholic acid (OCA), 6-ECDCA
Drug: Ursodeoxycholic Acid (URSO)
Stable dose for at least 6 months prior to screening. Dose as prescribed by physician.
Other Name: URSO, UDCA
Drug: Placebo
Placebo



Primary Outcome Measures :
  1. Alkaline Phosphatase (ALP). [ Time Frame: Baseline and 12 weeks ]
    The primary efficacy endpoint was the relative (%) change in plasma ALP from pretreatment values. The prestudy consensus opinion of the investigators was that a placebo-substracted ALP fall of ≥ 10% would be clinically significant.


Secondary Outcome Measures :
  1. Serum Gamma-Glutamyl Transpeptidase (GGT) [ Time Frame: Baseline and 12 weeks ]
    Percent change in serum gamma-glutamyl transpeptidase (GGT) from baseline to Day 85/early termination.

  2. Alanine Aminotransferase (ALT) [ Time Frame: Baseline and 12 weeks ]
    Mean percent change in serum alanine aminotransferase (ALT) from baseline to Day 85/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, Senior)
Sexes Eligible for Study:   All
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.

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 ClinicalTrials.gov identifier (NCT number): NCT00550862


  Show 32 Study Locations
Sponsors and Collaborators
Intercept Pharmaceuticals
Investigators
Study Director: David A Shapiro, MD Intercept Pharmaceuticals - Chief Medical Officer

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Intercept Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00550862     History of Changes
Other Study ID Numbers: 747-202
First Posted: October 30, 2007    Key Record Dates
Results First Posted: January 23, 2012
Last Update Posted: February 14, 2012
Last Verified: February 2012

Keywords provided by Intercept Pharmaceuticals:
PBC, Primary Biliary Cirrhosis, Liver,

Additional relevant MeSH terms:
Ursodeoxycholic Acid
Fibrosis
Liver Cirrhosis
Liver Cirrhosis, Biliary
Pathologic Processes
Liver Diseases
Digestive System Diseases
Cholestasis, Intrahepatic
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Chenodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents
Cathartics