Is a
Clinical Study attributes
NCT Number
Trial Recruitment Size
2170
Trial Sponsor
Clinical Trial Start Date
2012
0Primary Completion Date
2013
0Study Completion Date
December 17, 2018
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Drug0
Intervention Name
Placebo0
Obeticholic Acid (OCA)0
Interventional Trial Phase
Phase 30
Participating Facility
Official Name
A Phase 3, Double-Blind, Placebo-Controlled Trial and Long-Term Safety Extension of Obeticholic Acid in Patients With Primary Biliary Cirrhosis0
Last Updated
May 6, 2021
0Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Quadruple0
Masked Party
Investigator0
Participant0
Care Provider0
Outcomes Assessor0
Study summary
The main objectives of the study were to assess the effects of Obeticholic Acid (OCA) on serum alkaline phosphatase (ALP) and total bilirubin, together as a composite endpoint and on safety in participants with primary biliary cirrhosis (PBC).
Timeline
No Timeline data yet.
Further Resources
No Further Resources data yet.
