Is a
Clinical Study attributes
NCT Number
Trial Recruitment Size
600
Trial Sponsor
Clinical Trial Start Date
January 17, 2008
0Primary Completion Date
September 21, 2010
0Study Completion Date
September 25, 2017
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Drug0
Intervention Name
Placebo0
Obeticholic Acid (OCA)0
Interventional Trial Phase
Phase 20
Participating Facility
Official Name
A Study of INT-747 (6-ECDCA) Monotherapy in Patients With Primary Biliary Cirrhosis0
Last Updated
June 22, 2021
0Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Double0
Masked Party
Participant0
Investigator0
Study 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.
Timeline
No Timeline data yet.
Further Resources
No Further Resources data yet.
