Study of INT-747 as Monotherapy in Patients With PBC

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00570765
• Date of registration: 07/12/2007
• Prospective Registration: No
• Primary sponsor: Intercept Pharmaceuticals
• Public title: Study of INT-747 as Monotherapy in Patients With PBC
• Scientific title: A Study of INT-747 (6-ECDCA) Monotherapy in Patients With Primary Biliary Cirrhosis
• Date of first enrolment: November 2007
• Target sample size: 59
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00570765
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

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

Contacts

• Name: David A Shapiro, MD
• Affiliation: Intercept Pharmaceuticals

Key inclusion & exclusion 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.



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

Primary Outcome(s)

Alkaline Phosphatase (AP) Levels [Time Frame: Baseline and 12 weeks]

Secondary Outcome(s)

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

Hepatocellular Injury and Liver Function: ALT [Time Frame: Baeline and 12 weeks]

Hepatocellular Injury and Liver Function: GGT [Time Frame: Baeline and 12 weeks]

Secondary ID(s)

747-201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 07/07/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00570765