Trial · NCT01473524
Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis
NCT01473524, Phase 3, Completed, Intercept Pharmaceuticals; results first posted 2017-02-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis. Trials, record NCT01473524. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01473524
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis
- NCT number
- NCT01473524
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 217 participants, actual
- Lead sponsor
- Intercept Pharmaceuticals
- Conditions
- Primary Biliary Cirrhosis
- Interventions
- Obeticholic Acid (OCA), Placebo
- First posted
- 2011-11-17
- Last updated
- 2021-05-06
- Results first posted
- 2017-02-13
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | DB Phase: Composite Endpoint Alkaline Phosphatase (ALP) And Total Bilirubin, 10 mg OCA Versus Placebo | DB Month 12 | Percentage of participants at Month 12 with ALP \< 1.67 x upper limit of normal (ULN) and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline. |
| Primary | LTSE Phase: Composite Endpoint ALP And Total Bilirubin | Baseline (DB Month 12), LTSE Months 24, 36, 48, and 60 | Percentage of participants at Months 24, 36, 48, and 60 with ALP \< 1.67x ULN and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline. DB Month 12 is the baseline for the LTSE phase. |
| Secondary | DB Phase: Composite Endpoint ALP And Total Bilirubin, 10 mg Versus Placebo | DB Month 6 | Percentage of participants at Month 6 with ALP \< 1.67x ULN and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline. |
| Secondary | DB Phase: Composite Endpoint ALP And Total Bilirubin, 5-10 mg Versus Placebo | DB Month 12 | Percentage of participants at Month 12 with ALP \< 1.67x ULN and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline. |
| Secondary | DB Phase: Composite Endpoint ALP And Total Bilirubin, 5-10 mg Versus Placebo | DB Month 6 | Percentage of participants at Month 6 with ALP \< 1.67x ULN and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline. |
| Secondary | DB Phase: ALP Absolute Change From Baseline To Month 12 | Baseline, DB Month 12 | Blood samples were evaluated for ALP levels. ALP Absolute Change From Baseline (ALP at Month 12 - ALP at Baseline) is presented. |
| Secondary | DB Phase: Total Bilirubin Absolute Change From Baseline To Month 12 | Baseline, DB Month 12 | Blood samples were evaluated for bilirubin levels. Total bilirubin absolute change from baseline (total bilirubin at Month 12 - total bilirubin at Baseline) is presented. |
| Secondary | DB Phase: Direct Bilirubin Absolute Change From Baseline To Month 12 | Baseline, DB Month 12 | Blood samples were evaluated for bilirubin levels. Direct bilirubin absolute change from baseline (direct bilirubin at Month 12 - direct bilirubin at Baseline) is presented. |
| Secondary | DB Phase: Alanine Aminotransferase (ALT) Absolute Change From Baseline To Month 12 | Baseline, DB Month 12 | Blood samples were evaluated for ALT levels. ALT absolute change from baseline (ALT at Month 12 - ALT at Baseline) is presented. |
| Secondary | DB Phase: Aspartate Aminotransferase (AST) Absolute Change From Baseline To Month 12 | Baseline, DB Month 12 | Blood samples were evaluated for AST levels. AST absolute change from baseline (AST at Month 12 - AST at Baseline) is presented. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | DB Phase: Composite Endpoint Alkaline Phosphatase (ALP) And Total Bilirubin, 10 mg OCA Versus Placebo | DB Month 12 | Intent-to-Treat Population: All participants who were randomized and received at least 1 dose of study drug. | percentage of participants | NUMBER |
| PRIMARY | LTSE Phase: Composite Endpoint ALP And Total Bilirubin | Baseline (DB Month 12), LTSE Months 24, 36, 48, and 60 | All participants who received at least 1 dose of OCA in the open-label safety extension phase and had an assessment at the specified timepoint. | percentage of participants | NUMBER |
| SECONDARY | DB Phase: Composite Endpoint ALP And Total Bilirubin, 10 mg Versus Placebo | DB Month 6 | Intent-to-Treat Population: All participants who were randomized and received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | DB Phase: Composite Endpoint ALP And Total Bilirubin, 5-10 mg Versus Placebo | DB Month 12 | Intent-to-Treat Population: All participants who were randomized and received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | DB Phase: Composite Endpoint ALP And Total Bilirubin, 5-10 mg Versus Placebo | DB Month 6 | Intent-to-Treat Population: All participants who were randomized and received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | DB Phase: ALP Absolute Change From Baseline To Month 12 | Baseline, DB Month 12 | Intent-to-Treat Population: All participants who were randomized and received at least 1 dose of study drug and had an assessment at the specified timepoint. | U/L | LEAST_SQUARES_MEAN |
| SECONDARY | DB Phase: Total Bilirubin Absolute Change From Baseline To Month 12 | Baseline, DB Month 12 | Intent-to-Treat Population: All participants who were randomized and received at least 1 dose of study drug and had an assessment at the specified timepoint. | umol/L | LEAST_SQUARES_MEAN |
| SECONDARY | DB Phase: Direct Bilirubin Absolute Change From Baseline To Month 12 | Baseline, DB Month 12 | Intent-to-Treat Population: All participants who were randomized and received at least 1 dose of study drug and had an assessment at the specified timepoint. | umol/L | LEAST_SQUARES_MEAN |
| SECONDARY | DB Phase: Alanine Aminotransferase (ALT) Absolute Change From Baseline To Month 12 | Baseline, DB Month 12 | Intent-to-Treat Population: All participants who were randomized and received at least 1 dose of study drug and had an assessment at the specified timepoint. | U/L | LEAST_SQUARES_MEAN |
| SECONDARY | DB Phase: Aspartate Aminotransferase (AST) Absolute Change From Baseline To Month 12 | Baseline, DB Month 12 | Intent-to-Treat Population: All participants who were randomized and received at least 1 dose of study drug and had an assessment at the specified timepoint. | U/L | LEAST_SQUARES_MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group94
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| DB Phase: Composite Endpoint Alkaline Phosphatase (ALP) And Total Bilirubin, 10 mg OCA Versus Placebo | DB OCA 10 mg | 47 | percentage of participants | ||
| DB Phase: Composite Endpoint Alkaline Phosphatase (ALP) And Total Bilirubin, 10 mg OCA Versus Placebo | DB Placebo | 10 | percentage of participants | ||
| LTSE Phase: Composite Endpoint ALP And Total Bilirubin | LTSE OCA (DB OCA 5-10 mg) | Baseline (Double-blind Month 12) | 51 | percentage of participants | |
| LTSE Phase: Composite Endpoint ALP And Total Bilirubin | LTSE OCA (DB OCA 10 mg) | Baseline (Double-blind Month 12) | 56 | percentage of participants | |
| LTSE Phase: Composite Endpoint ALP And Total Bilirubin | LTSE OCA (DB Placebo) | Baseline (Double-blind Month 12) | 9 | percentage of participants | |
| LTSE Phase: Composite Endpoint ALP And Total Bilirubin | Overall LTSE OCA | Baseline (Double-blind Month 12) | 38 | percentage of participants | |
| LTSE Phase: Composite Endpoint ALP And Total Bilirubin | LTSE OCA (DB OCA 5-10 mg) | LTSE Month 12 | 55 | percentage of participants | |
| LTSE Phase: Composite Endpoint ALP And Total Bilirubin | LTSE OCA (DB OCA 10 mg) | LTSE Month 12 | 58 | percentage of participants | |
| LTSE Phase: Composite Endpoint ALP And Total Bilirubin | LTSE OCA (DB Placebo) | LTSE Month 12 | 41 | percentage of participants | |
| LTSE Phase: Composite Endpoint ALP And Total Bilirubin | Overall LTSE OCA | LTSE Month 12 | 51 | percentage of participants |
1 to 10 of 94Source ClinicalTrials.gov
See all 94 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| DB Phase | STARTED | DB OCA 5-10 mg | 71 | |
| DB Phase | STARTED | DB OCA 10 mg | 73 | |
| DB Phase | STARTED | DB Placebo | 73 | |
| DB Phase | STARTED | LTSE OCA (DB OCA 5-10 mg) | 0 | |
| DB Phase | STARTED | LTSE OCA (DB OCA 10 mg) | 0 | |
| DB Phase | STARTED | LTSE OCA (DB Placebo) | 0 | |
| DB Phase | Received at Least 1 Dose of Study Drug | DB OCA 5-10 mg | 70 | |
| DB Phase | Received at Least 1 Dose of Study Drug | DB OCA 10 mg | 73 | |
| DB Phase | Received at Least 1 Dose of Study Drug | DB Placebo | 73 | |
| DB Phase | Received at Least 1 Dose of Study Drug | LTSE OCA (DB OCA 5-10 mg) | 0 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events1,561
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 | Events |
|---|---|---|---|---|---|---|
| other | Pruritus | Skin and subcutaneous tissue disorders | DB 5-10 mg | 39 | 70 | 93 |
| other | Pruritus | Skin and subcutaneous tissue disorders | DB OCA 10 mg | 50 | 73 | 99 |
| other | Pruritus | Skin and subcutaneous tissue disorders | DB Placebo | 28 | 73 | 49 |
| other | Pruritus | Skin and subcutaneous tissue disorders | LTSE OCA (DB OCA 5-10 mg) | 49 | 63 | 249 |
| other | Pruritus | Skin and subcutaneous tissue disorders | LTSE OCA (DB 10 mg) | 51 | 64 | 198 |
| other | Pruritus | Skin and subcutaneous tissue disorders | LTSE OCA (DB Placebo) | 50 | 66 | 180 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Overall LTSE OCA | 150 | 193 | 627 |
| other | Rash | Skin and subcutaneous tissue disorders | DB 5-10 mg | 3 | 70 | 3 |
| other | Rash | Skin and subcutaneous tissue disorders | DB OCA 10 mg | 4 | 73 | 4 |
| other | Rash | Skin and subcutaneous tissue disorders | DB Placebo | 3 | 73 | 3 |
1 to 10 of 1,561Source ClinicalTrials.gov
See all 1,561 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DB 5-10 mg | ||
| Total, all-cause mortality | DB OCA 10 mg | ||
| Total, all-cause mortality | DB Placebo | ||
| Total, all-cause mortality | LTSE OCA (DB OCA 5-10 mg) | ||
| Total, all-cause mortality | LTSE OCA (DB 10 mg) | ||
| Total, all-cause mortality | LTSE OCA (DB Placebo) | ||
| Total, all-cause mortality | Overall LTSE OCA | ||
| Total, other adverse events | DB 5-10 mg | 64 | 70 |
| Total, other adverse events | DB OCA 10 mg | 64 | 73 |
| Total, other adverse events | DB Placebo | 62 | 73 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers7
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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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