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Farnesoid X receptor agonist

OCA: 10 mg for Primary Biliary Cirrhosis

Phase 2
Waitlist Available
Research Sponsored by Intercept Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 4, week 8/end of treatment (eot), week 12, month 6, month 12, month 18, month 24/eot
Awards & highlights

Summary

The purpose of this study was to determine if OCA had an effect on cholesterol levels in the blood in participants with primary biliary cirrhosis (PBC).

Eligible Conditions
  • Primary Biliary Cirrhosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 4, week 8/end of treatment (eot), week 12, month 6, month 12, month 18, month 24/eot
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4, week 8/end of treatment (eot), week 12, month 6, month 12, month 18, month 24/eot for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Area Under The Concentration-time Curve From Hour 0 To Last Sampling Time (Hour 6) (AUC0-6) For OCA And Conjugates
Maximum Plasma Concentration (Cmax) Of OCA And Conjugates
Median Change From Baseline In Alkaline Phosphatase
+14 more

Side effects data

From 2022 Phase 2 trial • 10 Patients • NCT02430077
40%
Itching
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo for Obeticholic Acid
Active Capsule of Obeticholic Acid

Trial Design

1Treatment groups
Experimental Treatment
Group I: OCA: 10 mgExperimental Treatment1 Intervention
Obeticholic acid, oral administration, 10 milligrams (mg), 8 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obeticholic Acid
2015
Completed Phase 2
~130

Find a Location

Who is running the clinical trial?

Intercept PharmaceuticalsLead Sponsor
28 Previous Clinical Trials
16,956 Total Patients Enrolled
David Shapiro, MDStudy DirectorIntercept Pharmaceuticals
4 Previous Clinical Trials
268 Total Patients Enrolled
George Harb, MDStudy DirectorIntercept Pharmaceuticals, Inc.
6 Previous Clinical Trials
5,584 Total Patients Enrolled
~2 spots leftby Sep 2025
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