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

NCT00550862 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2024-02-06

Study results available
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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.

Conditions

  • Liver Cirrhosis, Biliary

Interventions

DRUG

INT-747

Once a day (QD) by mouth (PO)

DRUG

Ursodeoxycholic Acid (URSO)

Stable dose for at least 6 months prior to screening. Dose as prescribed by physician.

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Intercept Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • David A Shapiro, MD · Intercept Pharmaceuticals - Chief Medical Officer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-08-31
Completion
2010-12-31

Countries

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

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00550862 on ClinicalTrials.gov