Trial · NCT03633227

Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment

NCT03633227, Phase 4, Terminated, Intercept Pharmaceuticals; results first posted 2022-09-06

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment. Trials, record NCT03633227. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03633227

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment
NCT number: NCT03633227
Status: Terminated
Phases: Phase 4
Enrollment: 22 participants, actual
Lead sponsor: Intercept Pharmaceuticals
Conditions: Liver Cirrhosis, Biliary
Interventions: Obeticholic Acid (OCA), Placebo
First posted: 2018-08-16
Last updated: 2022-09-06
Results first posted: 2022-09-06

Source ClinicalTrials.gov

Registered outcomes153

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Maximum Observed Concentration (Cmax) of Total OCA at Week 12	Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12	Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. Pharmacokinetics (PK) of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
Primary	Time to Maximum Concentration (Tmax) of Total OCA at Week 12	Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12	Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Primary	Trough Concentration (Ctrough) of Total OCA at Week 12	24 hours post-dose at Week 12	Ctrough was considered as the concentration at 24-hours post-dose at Week 12. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Primary	Area Under the Concentration Versus Time Curve From Zero Time to 24 Hours (AUC0-24h) of Total OCA at Week 12	Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12	Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule.
Primary	Cmax of Total OCA at Week 18	Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18	Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Primary	Tmax of Total OCA at Week 18	Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18	Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Primary	Ctrough of Total OCA at Week 18	24 hours post-dose at Week 18	Ctrough was considered as the concentration at 24-hours post-dose at Week 18. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Primary	AUC0-24h of Total OCA at Week 18	Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18	Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule.
Primary	Cmax of Total OCA at Week 24	Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24	Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Primary	Tmax of Total OCA at Week 24	Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24	Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.

1 to 10 of 153Source ClinicalTrials.gov

See all 153 registered outcomes

Outcomes153

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Maximum Observed Concentration (Cmax) of Total OCA at Week 12	Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12	PK Population: participants who received OCA and had adequate concentration-time profile to characterize OCA and its conjugates and must not have had any major protocol deviations that potentially affect exposure level. Results of PK were planned to be listed by dose regimen. Participants who received planned dose regimen and had available data were included in the analysis. No participant started OCA 5 mg twice weekly or 10 mg twice weekly at Week 12.	nanogram per milliliter (ng/mL)	MEAN
PRIMARY	Time to Maximum Concentration (Tmax) of Total OCA at Week 12	Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12	Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.	hours	MEDIAN
PRIMARY	Trough Concentration (Ctrough) of Total OCA at Week 12	24 hours post-dose at Week 12	Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.	ng/mL	MEAN
PRIMARY	Area Under the Concentration Versus Time Curve From Zero Time to 24 Hours (AUC0-24h) of Total OCA at Week 12	Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12	Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.	nanogramhour per milliliter (ngh/mL)	MEAN
PRIMARY	Cmax of Total OCA at Week 18	Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18	Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.	ng/mL	MEAN
PRIMARY	Tmax of Total OCA at Week 18	Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18	Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.	hours	MEDIAN
PRIMARY	Ctrough of Total OCA at Week 18	24 hours post-dose at Week 18	Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.	ng/mL	MEAN
PRIMARY	AUC0-24h of Total OCA at Week 18	Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18	Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.	ng*h/mL	MEAN
PRIMARY	Cmax of Total OCA at Week 24	Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24	Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.	ng/mL	MEAN
PRIMARY	Tmax of Total OCA at Week 24	Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24	Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.	hours	MEDIAN

1 to 10 of 153Source ClinicalTrials.gov

See all 153 outcomes

Results by group1,151

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Maximum Observed Concentration (Cmax) of Total OCA at Week 12	OCA 5 mg Once Weekly	293	Standard Deviation 189	nanogram per milliliter (ng/mL)
Time to Maximum Concentration (Tmax) of Total OCA at Week 12	OCA 5 mg Once Weekly	2.02	Full Range 2.00 to 3.00	hours
Trough Concentration (Ctrough) of Total OCA at Week 12	OCA 5 mg Once Weekly	77.6	Standard Deviation 49.7	ng/mL
Area Under the Concentration Versus Time Curve From Zero Time to 24 Hours (AUC0-24h) of Total OCA at Week 12	OCA 5 mg Once Weekly	2970	Standard Deviation 1650	nanogramhour per milliliter (ngh/mL)
Cmax of Total OCA at Week 18	OCA 5 mg Once Weekly	136	Standard Deviation 77.6	ng/mL
Cmax of Total OCA at Week 18	OCA 5 mg Twice Weekly	406	Standard Deviation 120	ng/mL
Tmax of Total OCA at Week 18	OCA 5 mg Once Weekly	0.750	Full Range 0.500 to 1.00	hours
Tmax of Total OCA at Week 18	OCA 5 mg Twice Weekly	2.52	Full Range 2.00 to 3.03	hours
Ctrough of Total OCA at Week 18	OCA 5 mg Once Weekly	28.7	Standard Deviation 13.6	ng/mL
Ctrough of Total OCA at Week 18	OCA 5 mg Twice Weekly	187	Standard Deviation 147	ng/mL

1 to 10 of 1,151Source ClinicalTrials.gov

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Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Double Blind (DB), up to Week 48	STARTED	Placebo	12
Double Blind (DB), up to Week 48	STARTED	Obeticholic Acid (OCA)	10
Double Blind (DB), up to Week 48	COMPLETED	Placebo	4
Double Blind (DB), up to Week 48	COMPLETED	Obeticholic Acid (OCA)	6
Double Blind (DB), up to Week 48	NOT COMPLETED	Placebo	8
Double Blind (DB), up to Week 48	NOT COMPLETED	Obeticholic Acid (OCA)	4
DB Extension, Week 48 up to 3 Years	STARTED	Placebo	4
DB Extension, Week 48 up to 3 Years	STARTED	Obeticholic Acid (OCA)	6
DB Extension, Week 48 up to 3 Years	COMPLETED	Placebo	0
DB Extension, Week 48 up to 3 Years	COMPLETED	Obeticholic Acid (OCA)	0

1 to 10 of 12Source ClinicalTrials.gov

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Adverse events230

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Ascites	Gastrointestinal disorders	Placebo	4	12
other	Ascites	Gastrointestinal disorders	Obeticholic Acid (OCA)	6	10
other	Abdominal distension	Gastrointestinal disorders	Placebo	3	12
other	Abdominal distension	Gastrointestinal disorders	Obeticholic Acid (OCA)	2	10
other	Abdominal pain	Gastrointestinal disorders	Placebo	1	12
other	Abdominal pain	Gastrointestinal disorders	Obeticholic Acid (OCA)	2	10
other	Diarrhoea	Gastrointestinal disorders	Placebo	1	12
other	Diarrhoea	Gastrointestinal disorders	Obeticholic Acid (OCA)	2	10
other	Nausea	Gastrointestinal disorders	Placebo	2	12
other	Nausea	Gastrointestinal disorders	Obeticholic Acid (OCA)	2	10

1 to 10 of 230Source ClinicalTrials.gov

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Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	2	12
Total, all-cause mortality	Obeticholic Acid (OCA)	2	10
Total, other adverse events	Placebo	10	12
Total, other adverse events	Obeticholic Acid (OCA)	10	10
Total, serious adverse events	Placebo	9	12
Total, serious adverse events	Obeticholic Acid (OCA)	7	10

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
19501929	BACKGROUND	PubMed
19554543	BACKGROUND	PubMed
25042402	BACKGROUND	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Obeticholic Acid (OCA) vs Placebo: deaths from any cause	Trial comparisons
Obeticholic Acid (OCA) vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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