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

I

Intercept Pharmaceuticals

Status and phase

Terminated
Phase 2

Conditions

Liver Cirrhosis, Biliary

Treatments

Drug: INT-747
Drug: Ursodeoxycholic Acid (URSO)
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00550862
747-202

Details and patient eligibility

About

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.

Full description

None provided

Enrollment

165 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

165 participants in 4 patient groups, including a placebo group

INT-747 10 mg
Experimental group
Description:
INT-747 10 mg once daily in combination with URSO for 12 weeks.
Treatment:
Drug: Ursodeoxycholic Acid (URSO)
Drug: INT-747
INT-747 25 mg
Experimental group
Description:
INT-747 25 mg once daily in combination with URSO for 12 weeks.
Treatment:
Drug: Ursodeoxycholic Acid (URSO)
Drug: INT-747
INT-747 50 mg
Experimental group
Description:
INT-747 50 mg once daily in combination with URSO for 12 weeks.
Treatment:
Drug: Ursodeoxycholic Acid (URSO)
Drug: INT-747
Placebo
Placebo Comparator group
Description:
Placebo once daily in combination with URSO for 12 weeks.
Treatment:
Drug: Placebo
Drug: Ursodeoxycholic Acid (URSO)
Drug: INT-747

Trial contacts and locations

32

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Data sourced from clinicaltrials.gov

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