Trial · NCT02548351
Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment
NCT02548351, Phase 3, Terminated, Intercept Pharmaceuticals; results first posted 2024-09-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment. Trials, record NCT02548351. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02548351
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment
- NCT number
- NCT02548351
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 2,477 participants, actual
- Lead sponsor
- Intercept Pharmaceuticals
- Conditions
- Non Alcoholic Steatohepatitis (NASH)
- Interventions
- Obeticholic Acid, Placebo
- First posted
- 2015-09-14
- Last updated
- 2024-10-01
- Results first posted
- 2024-09-05
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to the First Adjudicated Event for Clinical Outcome Composite Endpoint: Percentage of Participants With an Event | Up to 7 years | All potential liver-related clinical outcomes that occurred after administration of first dose of investigational product were reviewed and adjudicated by blinded, independent Hepatic Outcomes Committee(HOC). Adjudicated results were used to assess effect of OCA, compared to placebo in conjunction with established local standard of care, on clinical outcomes in participants with NASH as measured by time to first occurrence of any of following adjudicated events, derived as a composite event endpoint of death(all-cause), liver transplant, Model of End-stage Liver Disease(MELD)≥15 Score, hospitalization(defined by a stay of 24 hours or greater) for onset of: variceal bleed, hepatic encephalopathy(defined by a West Haven score of ≥2), and spontaneous bacterial peritonitis(confirmed by diagnostic paracentesis), ascites secondary to cirrhosis requiring medical intervention, and histological progression to Cirrhosis. Clinical events distribution was estimated using Kaplan-Meier methodology. |
| Secondary | Percentage of Responders With Improvement of Fibrosis by at Least One Stage With no Worsening of NASH Using Consensus Read Method of Scheduled Liver Biopsies | Up to 7 years | Fibrosis stage was evaluated by NASH Clinical Research Network (CRN) Fibrosis Staging System as follows: Stage 0: No fibrosis, Stage 1: Perisinusoidal/periportal fibrosis, Stage 1A: Mild, zone 3, perisinusoidal fibrosis, Stage 1B: Moderate, zone 3, perisinusoidal fibrosis, Stage 1C: Portal/periportal fibrosis, Stage 2: Perisinusoidal and portal/periportal fibrosis, Stage 3: Bridging fibrosis and Stage 4: Cirrhosis. No worsening of NASH was defined as no worsening of hepatocellular ballooning, no worsening of lobular inflammation, and no worsening of steatosis. Responders are defined as participants who did not discontinue treatment due to Adverse event (AE) or did not die and had evaluable post-Baseline biopsy assessment. Mantel-Haenszel method is used to construct the confidence intervals. |
| Secondary | Percentage of Participants Who Showed Improvement in Fibrosis by at Least 1 Stage and/or Resolution of NASH Without Worsening of Either Using Consensus Read Method | Up to 7 years | Fibrosis stage was evaluated by NASH Clinical Research Network(CRN) Fibrosis Staging System as follows: Stage 0:No fibrosis, Stage 1:Perisinusoidal/periportal fibrosis, Stage 1A:Mild, zone 3, perisinusoidal fibrosis, Stage 1B:Moderate, zone3, perisinusoidal fibrosis, Stage 1C:Portal/periportal fibrosis, Stage 2:Perisinusoidal and portal/periportal fibrosis, Stage 3:Bridging fibrosis and Stage 4:Cirrhosis. Resolution of NASH (Nonalcoholic Steatohepatitis) is defined as absence of fatty liver disease, or presence of simple or isolated steatosis without steatohepatitis, with a NAS(NAFLD Activity Score) of 0 for ballooning and 0 to 1 for inflammation. NAS ranges from 0-12; 0: no features of fatty liver disease and 12: highest degree of fatty liver disease. Higher signify worse symptoms. Responders are who did not discontinue treatment due to Adverse event(AE) or did not die and had evaluable post-Baseline biopsy assessment. Mantel-Haenszel method is used to construct confidence intervals. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to 7 years | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A TEAE was defined as any AE that either newly appeared, increased in frequency, or worsened in severity following treatment up to 30 days from last dose of permanent investigational product discontinuation. Serious AE (SAE) was defined as any AE resulting in death, immediate risk of death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or a congenital/anomaly/birth defect, or any other medically important event. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to the First Adjudicated Event for Clinical Outcome Composite Endpoint: Percentage of Participants With an Event | Up to 7 years | Intent-to-Treat (ITT) Population comprised of all randomized participants with fibrosis stage 2 or stage 3 who receive at least 1 dose of investigational product. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Responders With Improvement of Fibrosis by at Least One Stage With no Worsening of NASH Using Consensus Read Method of Scheduled Liver Biopsies | Up to 7 years | ITT Population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Showed Improvement in Fibrosis by at Least 1 Stage and/or Resolution of NASH Without Worsening of Either Using Consensus Read Method | Up to 7 years | ITT Population. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to 7 years | Safety Population comprised all randomized participants, all fibrosis stages, who receive at least 1 dose of investigational product (OCA or placebo). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to the First Adjudicated Event for Clinical Outcome Composite Endpoint: Percentage of Participants With an Event | OCA 10 Milligrams (mg) | 15.8 | 95% Confidence Interval 13.2 to 18.6 | Percentage of participants | |
| Time to the First Adjudicated Event for Clinical Outcome Composite Endpoint: Percentage of Participants With an Event | OCA 25 mg | 14.7 | 95% Confidence Interval 12.2 to 17.4 | Percentage of participants | |
| Time to the First Adjudicated Event for Clinical Outcome Composite Endpoint: Percentage of Participants With an Event | Placebo | 18.8 | 95% Confidence Interval 16.0 to 21.9 | Percentage of participants | |
| Percentage of Responders With Improvement of Fibrosis by at Least One Stage With no Worsening of NASH Using Consensus Read Method of Scheduled Liver Biopsies | OCA 10 Milligrams (mg) | 17.1 | Percentage of participants | ||
| Percentage of Responders With Improvement of Fibrosis by at Least One Stage With no Worsening of NASH Using Consensus Read Method of Scheduled Liver Biopsies | OCA 25 mg | 19.5 | Percentage of participants | ||
| Percentage of Responders With Improvement of Fibrosis by at Least One Stage With no Worsening of NASH Using Consensus Read Method of Scheduled Liver Biopsies | Placebo | 10.0 | Percentage of participants | ||
| Percentage of Participants Who Showed Improvement in Fibrosis by at Least 1 Stage and/or Resolution of NASH Without Worsening of Either Using Consensus Read Method | OCA 10 Milligrams (mg) | 18.5 | Percentage of participants | ||
| Percentage of Participants Who Showed Improvement in Fibrosis by at Least 1 Stage and/or Resolution of NASH Without Worsening of Either Using Consensus Read Method | OCA 25 mg | 20.8 | Percentage of participants | ||
| Percentage of Participants Who Showed Improvement in Fibrosis by at Least 1 Stage and/or Resolution of NASH Without Worsening of Either Using Consensus Read Method | Placebo | 11.8 | Percentage of participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | OCA 10 Milligrams (mg) | TEAEs | 798 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | OCA 10 Milligrams (mg) | 825 | |
| Overall Study | STARTED | OCA 25 mg | 827 | |
| Overall Study | STARTED | Placebo | 825 | |
| Overall Study | COMPLETED | OCA 10 Milligrams (mg) | 0 | |
| Overall Study | COMPLETED | OCA 25 mg | 0 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | OCA 10 Milligrams (mg) | 825 | |
| Overall Study | NOT COMPLETED | OCA 25 mg | 827 | |
| Overall Study | NOT COMPLETED | Placebo | 825 |
Source ClinicalTrials.gov
Adverse events1,854
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 | OCA 10 Milligrams (mg) | 294 | 825 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | OCA 25 mg | 470 | 827 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Placebo | 210 | 825 | |
| other | Rash | Skin and subcutaneous tissue disorders | OCA 10 Milligrams (mg) | 46 | 825 | |
| other | Rash | Skin and subcutaneous tissue disorders | OCA 25 mg | 61 | 827 | |
| other | Rash | Skin and subcutaneous tissue disorders | Placebo | 48 | 825 | |
| other | Pruritus generalised | Skin and subcutaneous tissue disorders | OCA 10 Milligrams (mg) | 15 | 825 | |
| other | Pruritus generalised | Skin and subcutaneous tissue disorders | OCA 25 mg | 55 | 827 | |
| other | Pruritus generalised | Skin and subcutaneous tissue disorders | Placebo | 13 | 825 | |
| other | Urinary tract infection | Infections and infestations | OCA 10 Milligrams (mg) | 147 | 825 |
1 to 10 of 1,854Source ClinicalTrials.gov
See all 1,854 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OCA 10 Milligrams (mg) | 14 | 825 |
| Total, all-cause mortality | OCA 25 mg | 19 | 827 |
| Total, all-cause mortality | Placebo | 14 | 825 |
| Total, other adverse events | OCA 10 Milligrams (mg) | 798 | 825 |
| Total, other adverse events | OCA 25 mg | 813 | 827 |
| Total, other adverse events | Placebo | 781 | 825 |
| Total, serious adverse events | OCA 10 Milligrams (mg) | 273 | 825 |
| Total, serious adverse events | OCA 25 mg | 276 | 827 |
| Total, serious adverse events | Placebo | 248 | 825 |
Source ClinicalTrials.gov
Papers5
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.
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/NCT02548351
GET https://conductscience.org/api/trials/v1/NCT02548351/events?page=2