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Study Title: A study of INT-747 (6-ECDCA) in combination with ursodeoxycholic acid (URSO ®, UDCA) in patients with primary biliary cirrhosis
Category: Gastroenterology
Currently accepting participants?
Not at this time.
Principal Investigator: Kris Kowdley
Study Coordinator: Cheryl Saunders
Phone: 206-341-1786
Email: Cheryl.saunders@vmmc.org
What is the A study of INT-747 (6-ECDCA) in combination with ursodeoxycholic acid (URSO ®, UDCA) in patients with primary biliary cirrhosis study?
A study to evaluate the investigational drug INT-747 in combination with ursodeoxycholic acid in patients with primary biliary cirrhosis that have been on a steady dose of URSO® for at least the past 6 months The study lasts about 18 weeks, with 7 clinical visits. The visit procedures will include vital signs, an ECG, questionnaires, blood and urine collection, a physical exam and information about current mediacations and medical history.
Who can participate?
Males or females 18-70 that have been on a stable dose of ursodeoxycholic acid for at least 6 months prior to screening and have proven or likely primary biliary cirrhosis
Study Summary:
A study to evaluate the investigational drug INT-747 in combination with ursodeoxycholic acid in patients with primary biliary cirrhosis that have been on a steady dose of URSO® for at least the past 6 months The study lasts about 18 weeks, with 7 clinical visits. The visit procedures will include vital signs, an ECG, questionnaires, blood and urine collection, a physical exam and information about current mediacations and medical history.
Detailed Study Description:
(No information)
Study Design: Blinded
Phase of Study: Phase II
Study Type: Interventional
Condition or Study Focus: Primary Biliary Cirrhosis
Intervention Type: Drug
Intervention Name: INT-747
Gender: Male and Female
Age group: Interventional
Sponsor: Intercept Pharmaceuticals