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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00550862
• Date of registration: 27/10/2007
• Prospective Registration: No
• Primary sponsor: Intercept Pharmaceuticals
• Public title: Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)
• Scientific title: A Study of INT 747 (6a-ethyl Chenodeoxycholic Acid (6-ECDCA)) in Combination With Ursodeoxycholic Acid (URSO®, UDCA) in Patients With Primary Biliary Cirrhosis
• Date of first enrolment: October 2007
• Target sample size: 165
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00550862
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Austria, Canada, France, Germany, Netherlands, Spain, United Kingdom, United States

Contacts

• Name: David A Shapiro, MD
• Affiliation: Intercept Pharmaceuticals - Chief Medical Officer

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Liver Cirrhosis, Biliary

Intervention(s)

Drug: Placebo

Drug: INT-747

Drug: Ursodeoxycholic Acid (URSO)

Primary Outcome(s)

Alkaline Phosphatase (ALP). [Time Frame: Baseline and 12 weeks]

Secondary Outcome(s)

Plasma Trough Concentrations of INT-747 and Its Major, Known Metabolites [Time Frame: 12 Weeks]

Serum Gamma-Glutamyl Transpeptidase (GGT) [Time Frame: Baseline and 12 weeks]

Alanine Aminotransferase (ALT) [Time Frame: Baseline and 12 weeks]

Secondary ID(s)

747-202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/01/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00550862