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

• Status: Completed
• Trial end date: 2017-09-25
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Intercept Pharmaceuticals
• Treatments: Chenodeoxycholic Acid

Criteria

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.