Trial · NCT02177136
Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC)
NCT02177136, Phase 2, Completed, Intercept Pharmaceuticals; results first posted 2018-05-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC). Trials, record NCT02177136. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02177136
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC)
- NCT number
- NCT02177136
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 77 participants, actual
- Lead sponsor
- Intercept Pharmaceuticals
- Conditions
- Primary Sclerosing Cholangitis (PSC)
- Interventions
- Obeticholic Acid (OCA), Placebo
- First posted
- 2014-06-27
- Last updated
- 2021-07-08
- Other registries' IDs
- eudract:2014-002205-38
- Results first posted
- 2018-05-30
- Limitations and caveats
- Due to administrative reasons, the study was terminated by the Sponsor prior to most participants completing LTSE Month 24.
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | DB Phase: Change From Baseline In Serum Alkaline Phosphatase (ALP) | Baseline, Week 24 | The primary efficacy analysis compared the Week 24 change from Baseline in ALP between OCA treatment group and placebo using an analysis of covariance (ANCOVA) model with fixed effects for treatment group and randomization strata, and Baseline as a covariate. Results are reported in U/L. |
| Primary | LTSE Phase: Incidence Of Adverse Events Of Special Interest (AESIs) | LTSE Baseline (DB Week 24) to Month 26 | The primary safety analysis evaluated the effects of OCA treatment on AESIs of pruritus, hepatic disorders, and dyslipidemia. All adverse event (AE) summaries were restricted to treatment emergent AEs (TEAEs), which were defined as any AEs that newly appeared, increased in frequency, or worsened in severity following initiation of investigational product. Treatment-emergent pruritus was defined as any preferred term (PT) including "Prur-". Hepatic disorder AESIs were defined using specific Hepatic Disorders Standardized Medical Dictionary for Regulatory Activities (MedDRA) Query (SMQ) terms. AE lipid profile changes, defined in the Dyslipidemia SMQ, were reported. Verbatim terms were mapped to PTs and system organ classes (SOCs) using MedDRA version 17.1 for all AE summaries except those for hepatic disorder AESIs, which used MedDRA version 18.1. A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. |
| Secondary | DB Phase: Change From Baseline In Serum Alanine Transaminase (ALT) | Baseline, Week 24 | As a marker of hepatic biochemistry and liver function, the median change in ALT from Baseline at Week 24 is reported. Results are reported in U/L. |
| Secondary | DB Phase: Change From Baseline In Serum Aspartate Aminotransferase (AST) | Baseline, Week 24 | As a marker of hepatic biochemistry and liver function, the median change in AST from Baseline at Week 24 is reported. Results are reported in U/L. |
| Secondary | DB Phase: Change From Baseline In Serum Total Bilirubin | Baseline, Week 24 | As a marker of hepatic biochemistry and liver function, the median change in serum total bilirubin from Baseline at Week 24 is reported. Results are reported in umol/L. |
| Secondary | DB Phase: Change From Baseline In Serum Direct Bilirubin | Baseline, Week 24 | As a marker of hepatic biochemistry and liver function, the median change in serum direct bilirubin from Baseline at Week 24 is reported. Results are reported in umol/L. |
| Secondary | DB Phase: Change From Baseline In Serum Gamma-glutamyl Transferase (GGT) | Baseline, Week 24 | As a marker of hepatic biochemistry and liver function, the median change in serum GGT from Baseline at Week 24 is reported. Results are reported in U/L. |
| Secondary | DB Phase: Change From Baseline In Plasma Fibroblast Growth Factor-19 (FGF-19) | Baseline, Week 24 | To assess farnesoid X receptor (FXR) activity, the change in FGF-19 from Baseline at Week 24 is reported. Results are reported in picograms/milliliter (pg/mL). |
| Secondary | DB Phase: Change From Baseline In Plasma 7α-Hydroxy-4-cholesten-3-one (C4) | Baseline, Week 24 | To assess FXR activity, the change in plasma C4 from Baseline at Week 24 is reported. Results are reported in nanograms (ng)/mL. |
| Secondary | LTSE Phase: Change From Baseline In Serum ALP At Month 12 | LTSE Baseline (DB Week 24), Month 12 | The median change in serum ALP from Baseline to the last available visit is reported. The DB value at Week 24 was used as the Baseline. Results are reported in U/L. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | DB Phase: Change From Baseline In Serum Alkaline Phosphatase (ALP) | Baseline, Week 24 | Intent-to-Treat Population: All randomized participants who received any amount of investigational product within the DB phase. | U/L | LEAST_SQUARES_MEAN |
| PRIMARY | LTSE Phase: Incidence Of Adverse Events Of Special Interest (AESIs) | LTSE Baseline (DB Week 24) to Month 26 | LTSE Population: All participants who received any amount of investigational product during the LTSE phase. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | DB Phase: Change From Baseline In Serum Alanine Transaminase (ALT) | Baseline, Week 24 | Intent-To-Treat Population: All randomized participants who received any amount of investigational product within the DB phase. | U/L | MEDIAN |
| SECONDARY | DB Phase: Change From Baseline In Serum Aspartate Aminotransferase (AST) | Baseline, Week 24 | Intent-to-Treat Population: All randomized participants who received any amount of investigational product within the DB phase. | U/L | MEDIAN |
| SECONDARY | DB Phase: Change From Baseline In Serum Total Bilirubin | Baseline, Week 24 | Intent-To-Treat Population: All randomized participants who received any amount of investigational product within the DB phase. | umol/L | MEDIAN |
| SECONDARY | DB Phase: Change From Baseline In Serum Direct Bilirubin | Baseline, Week 24 | Intent-To-Treat Population: All randomized participants who received any amount of investigational product within the DB phase. | umol/L | MEDIAN |
| SECONDARY | DB Phase: Change From Baseline In Serum Gamma-glutamyl Transferase (GGT) | Baseline, Week 24 | Intent-To-Treat Population: All randomized participants who received any amount of investigational product within the DB phase. | U/L | MEDIAN |
| SECONDARY | DB Phase: Change From Baseline In Plasma Fibroblast Growth Factor-19 (FGF-19) | Baseline, Week 24 | Intent-to-Treat Population: All randomized participants who received any amount of investigational product within the DB phase. | pg/mL | MEDIAN |
| SECONDARY | DB Phase: Change From Baseline In Plasma 7α-Hydroxy-4-cholesten-3-one (C4) | Baseline, Week 24 | Intent-To-Treat Population: All randomized participants who received any amount of investigational product within the DB phase. | ng/mL | MEDIAN |
| SECONDARY | LTSE Phase: Change From Baseline In Serum ALP At Month 12 | LTSE Baseline (DB Week 24), Month 12 | LTSE Population: All participants who received any amount of investigational product during the LTSE phase and had an efficacy assessment at the specified time points. | U/L | MEDIAN |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| DB Phase: Change From Baseline In Serum Alkaline Phosphatase (ALP) | 1.5 mg OCA Titrating to 3 mg OCA | -105.05 | Standard Error 38.02 | U/L | |
| DB Phase: Change From Baseline In Serum Alkaline Phosphatase (ALP) | 5 mg OCA Titrating to 10 mg OCA | -110.19 | Standard Error 33.77 | U/L | |
| DB Phase: Change From Baseline In Serum Alkaline Phosphatase (ALP) | Placebo | -26.76 | Standard Error 36.65 | U/L | |
| LTSE Phase: Incidence Of Adverse Events Of Special Interest (AESIs) | LTSE OCA Total | Dyslipidaemia | 1 | Participants | |
| LTSE Phase: Incidence Of Adverse Events Of Special Interest (AESIs) | LTSE OCA Total | Hepatic Disorder | 23 | Participants | |
| LTSE Phase: Incidence Of Adverse Events Of Special Interest (AESIs) | LTSE OCA Total | Pruritus | 34 | Participants | |
| DB Phase: Change From Baseline In Serum Alanine Transaminase (ALT) | 1.5 mg OCA Titrating to 3 mg OCA | -33.0 | Inter-Quartile Range -50.5 to 5.0 | U/L | |
| DB Phase: Change From Baseline In Serum Alanine Transaminase (ALT) | 5 mg OCA Titrating to 10 mg OCA | -5.5 | Inter-Quartile Range -30.0 to 4.5 | U/L | |
| DB Phase: Change From Baseline In Serum Alanine Transaminase (ALT) | Placebo | -19.5 | Inter-Quartile Range -49.0 to 4.0 | U/L | |
| DB Phase: Change From Baseline In Serum Aspartate Aminotransferase (AST) | 1.5 mg OCA Titrating to 3 mg OCA | -8.0 | Inter-Quartile Range -20.0 to 19.0 | U/L |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow32
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| DB Phase | STARTED | 1.5 mg OCA Titrating to 3 mg OCA | 26 | |
| DB Phase | STARTED | 5 mg OCA Titrating to 10 mg OCA | 26 | |
| DB Phase | STARTED | Placebo | 25 | |
| DB Phase | STARTED | LTSE OCA Total | 0 | |
| DB Phase | Received At Least 1 Dose Of Study Drug | 1.5 mg OCA Titrating to 3 mg OCA | 25 | |
| DB Phase | Received At Least 1 Dose Of Study Drug | 5 mg OCA Titrating to 10 mg OCA | 26 | |
| DB Phase | Received At Least 1 Dose Of Study Drug | Placebo | 25 | |
| DB Phase | Received At Least 1 Dose Of Study Drug | LTSE OCA Total | 0 | |
| DB Phase | COMPLETED | 1.5 mg OCA Titrating to 3 mg OCA | 19 | |
| DB Phase | COMPLETED | 5 mg OCA Titrating to 10 mg OCA | 21 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 participant flowAdverse events336
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 | 1.5 mg OCA Titrating to 3 mg OCA | 15 | 25 | 31 |
| other | Pruritus | Skin and subcutaneous tissue disorders | 5 mg OCA Titrating to 10 mg OCA | 18 | 27 | 38 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Placebo | 11 | 24 | 17 |
| other | Pruritus | Skin and subcutaneous tissue disorders | LTSE OCA Total | 33 | 59 | 62 |
| other | Urticaria | Skin and subcutaneous tissue disorders | 1.5 mg OCA Titrating to 3 mg OCA | 2 | 25 | 2 |
| other | Urticaria | Skin and subcutaneous tissue disorders | 5 mg OCA Titrating to 10 mg OCA | 0 | 27 | 0 |
| other | Urticaria | Skin and subcutaneous tissue disorders | Placebo | 0 | 24 | 0 |
| other | Urticaria | Skin and subcutaneous tissue disorders | LTSE OCA Total | 1 | 59 | 1 |
| other | Nausea | Gastrointestinal disorders | 1.5 mg OCA Titrating to 3 mg OCA | 2 | 25 | 2 |
| other | Nausea | Gastrointestinal disorders | 5 mg OCA Titrating to 10 mg OCA | 6 | 27 | 7 |
1 to 10 of 336Source ClinicalTrials.gov
See all 336 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1.5 mg OCA Titrating to 3 mg OCA | 0 | 25 |
| Total, all-cause mortality | 5 mg OCA Titrating to 10 mg OCA | 0 | 27 |
| Total, all-cause mortality | Placebo | 0 | 24 |
| Total, all-cause mortality | LTSE OCA Total | 0 | 59 |
| Total, other adverse events | 1.5 mg OCA Titrating to 3 mg OCA | 20 | 25 |
| Total, other adverse events | 5 mg OCA Titrating to 10 mg OCA | 24 | 27 |
| Total, other adverse events | Placebo | 21 | 24 |
| Total, other adverse events | LTSE OCA Total | 53 | 59 |
| Total, serious adverse events | 1.5 mg OCA Titrating to 3 mg OCA | 4 | 25 |
| Total, serious adverse events | 5 mg OCA Titrating to 10 mg OCA | 4 | 27 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32165251 | RESULT |
Source 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 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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02177136
GET https://conductscience.org/api/trials/v1/NCT02177136/registered?page=2