Trial · NCT00550862
Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)
NCT00550862, Phase 2, Terminated, Intercept Pharmaceuticals; results first posted 2012-01-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC). Trials, record NCT00550862. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00550862
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)
- NCT number
- NCT00550862
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 165 participants, actual
- Lead sponsor
- Intercept Pharmaceuticals
- Conditions
- Liver Cirrhosis, Biliary
- Interventions
- INT-747, Ursodeoxycholic Acid (URSO), Placebo
- First posted
- 2007-10-30
- Last updated
- 2024-02-06
- Results first posted
- 2012-01-23
Source ClinicalTrials.gov
Registered outcomes37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Double-blind Phase: Percent Change From Baseline in Serum Alkaline Phosphatase (ALP) | Baseline and Up to Day 85 | Blood samples were collected for the analysis of serum ALP. Baseline was defined as the last observed value before the first dose of investigational product (Day 0). Percent change from Baseline was calculated as Post Baseline minus Baseline value divided by Baseline value and multiplied by 100. |
| Secondary | Double-blind Phase: Absolute Values for Serum ALP, Aspartate Aminotransferase (AST), Alanine Transaminase (ALT) and Gamma-glutamyl Transferase (GGT) Levels | Baseline and at Days 15, 29, 57 and 85 | Blood samples were collected for the analysis of serum chemistry parameters including ALP, AST, ALT and GGT. Baseline was defined as the last observed value before the first dose of investigational product (Day 0). |
| Secondary | Double-blind Phase: Percent Change From Baseline in Serum ALP, AST, ALT and GGT Levels | Baseline and at Days 15, 29, 57 and 85 | Blood samples were collected for the analysis of serum chemistry parameters including ALP, AST, ALT and GGT. Baseline was defined as the last observed value before the first dose of investigational product (Day 0). Percent change from Baseline was calculated as Post Baseline minus Baseline value divided by Baseline value and multiplied by 100. |
| Secondary | LTSE Phase: Mean Percent Change From Baseline in Serum ALP, AST, ALT and GGT Levels | Baseline and at 3, 6, 9 and 12 Months | Blood samples were collected for the analysis of serum chemistry parameters including ALP, AST, ALT and GGT. Baseline was defined as the last observed value before the first dose of investigational product (Day 85). Percent change from Baseline was calculated as Post Baseline minus Baseline value divided by Baseline value and multiplied by 100. |
| Secondary | Double-blind Phase: Absolute Values for Albumin Levels | Baseline and at Days 15, 29, 57 and 85 | Blood samples were collected for the analysis of serum chemistry parameter: Albumin. Baseline was defined as the last observed value before the first dose of investigational product (Day 0). |
| Secondary | Double-blind Phase: Percent Change From Baseline in Albumin Levels | Baseline and at Days 15, 29, 57 and 85 | Blood samples were collected for the analysis of serum chemistry parameter: Albumin. Baseline was defined as the last observed value before the first dose of investigational product (Day 0). Percent change from Baseline was calculated as Post Baseline minus Baseline value divided by Baseline value and multiplied by 100. |
| Secondary | Double-blind Phase: Absolute Values for Conjugated (Direct) Bilirubin | Baseline and at Days 15, 29, 57 and 85 | Blood samples were collected for the analysis of serum chemistry parameter: Conjugated (Direct) bilirubin. Baseline was defined as the last observed value before the first dose of investigational product (Day 0). |
| Secondary | Double-blind Phase: Percent Change From Baseline in Conjugated (Direct) Bilirubin | Baseline and at Days 15, 29, 57 and 85 | Blood samples were collected for the analysis of serum chemistry parameter: Direct bilirubin. Baseline was defined as the last observed value before the first dose of investigational product (Day 0). Percent change from Baseline was calculated as Post Baseline minus Baseline value divided by Baseline value and multiplied by 100. |
| Secondary | LTSE Phase: Mean Percent Change From Baseline in Total and Conjugated (Direct) Bilirubin | Baseline and at 3, 6, 9 and 12 Months | Blood samples were collected for the analysis of serum chemistry parameters Total and direct bilirubin. Baseline was defined as the last observed value before the first dose of investigational product (Day 85). Percent change from Baseline was calculated as Post Baseline minus Baseline value divided by Baseline value and multiplied by 100. |
| Secondary | Double-blind Phase: Change From Baseline in Enhanced Liver Fibrosis (ELF) Score | Baseline and up to Day 85 | Enhanced Liver Fibrosis (ELF) combines measurements of tissue inhibitor of metalloprotein-ases-1 (TIMP-1), amino-terminal pro-peptide of type III procollagen (PIIINP), and hyaluronic acid (HA). The ELF score is calculated as: 2.278 + 0.851 ln (HA) + 0.751 ln (PIIINP) + 0.394 ln (TIMP-1). An ELF score of less than 7.7 indicates no to mild fibrosis; ≥ 7.7 - \< 9.8: Moderate fibrosis; ≥ 9.8 - \< 11.3: Severe fibrosis; ≥ 11.3: Cirrhosis. A negative change from Baseline indicates decreased fibrosis. Higher the ELF is associated with higher fibrosis stages and greater the risk of progression. A minimum and maximum value for the scale range does not exist for this assessment. Baseline was defined as the last observed value before the first dose of investigational product (Day 0). Change from Baseline is defined as post-dose visit value minus Baseline value. |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 registered outcomesOutcomes37
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Double-blind Phase: Percent Change From Baseline in Serum Alkaline Phosphatase (ALP) | Baseline and Up to Day 85 | Modified Intent-to-Treat (mITT) Population (N=161) comprised of all randomized participants who received at least 1 dose of investigational product and had at least 1 post-Baseline ALP evaluation taken ≤7 days after their last dose of investigational product. | Percent change | MEAN |
| SECONDARY | Double-blind Phase: Absolute Values for Serum ALP, Aspartate Aminotransferase (AST), Alanine Transaminase (ALT) and Gamma-glutamyl Transferase (GGT) Levels | Baseline and at Days 15, 29, 57 and 85 | Intent-to-Treat (ITT) Population (N=165) comprises all randomized participants who received at least 1 dose of investigational product. Only those participants with data available at specified timepoints has been presented. | Units per liter | MEAN |
| SECONDARY | Double-blind Phase: Percent Change From Baseline in Serum ALP, AST, ALT and GGT Levels | Baseline and at Days 15, 29, 57 and 85 | ITT Population (N=165). Only those participants with data available at specified timepoints has been presented (n=164). | Percent change | MEAN |
| SECONDARY | LTSE Phase: Mean Percent Change From Baseline in Serum ALP, AST, ALT and GGT Levels | Baseline and at 3, 6, 9 and 12 Months | Safety Population (N=78) comprised of all randomized participants who received at least 1 dose of investigational product. Only those participants with data available at specified timepoints has been presented (n=69). | Percent change | MEAN |
| SECONDARY | Double-blind Phase: Absolute Values for Albumin Levels | Baseline and at Days 15, 29, 57 and 85 | ITT Population (N=165). Only those participants with data available at specified timepoints has been presented. | Grams per liter | MEAN |
| SECONDARY | Double-blind Phase: Percent Change From Baseline in Albumin Levels | Baseline and at Days 15, 29, 57 and 85 | ITT Population (N=165). Only those participants with data available at specified timepoints has been presented. | Percent change | MEAN |
| SECONDARY | Double-blind Phase: Absolute Values for Conjugated (Direct) Bilirubin | Baseline and at Days 15, 29, 57 and 85 | ITT Population (N=165). Only those participants with data available at specified timepoints has been presented. | Micromoles per liter | MEAN |
| SECONDARY | Double-blind Phase: Percent Change From Baseline in Conjugated (Direct) Bilirubin | Baseline and at Days 15, 29, 57 and 85 | ITT Population (N=165). Only those participants with data available at specified timepoints has been presented (n=164). | Percent change | MEAN |
| SECONDARY | LTSE Phase: Mean Percent Change From Baseline in Total and Conjugated (Direct) Bilirubin | Baseline and at 3, 6, 9 and 12 Months | Safety Population (N=78). Only those participants with data available at specified timepoints has been presented (n=69) | Percent change | MEAN |
| SECONDARY | Double-blind Phase: Change From Baseline in Enhanced Liver Fibrosis (ELF) Score | Baseline and up to Day 85 | ITT Population (N=165). Only those participants with data available at specified timepoints has been presented (n=146). | Scores on a scale | MEAN |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 outcomesResults by group568
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Double-blind Phase: Percent Change From Baseline in Serum Alkaline Phosphatase (ALP) | Obeticholic Acid (OCA) 10 Milligrams (mg) | -23.7 | Standard Deviation 17.8 | Percent change | |
| Double-blind Phase: Percent Change From Baseline in Serum Alkaline Phosphatase (ALP) | OCA 25 mg | -24.7 | Standard Deviation 17.9 | Percent change | |
| Double-blind Phase: Percent Change From Baseline in Serum Alkaline Phosphatase (ALP) | OCA 50 mg | -21.0 | Standard Deviation 27.6 | Percent change | |
| Double-blind Phase: Percent Change From Baseline in Serum Alkaline Phosphatase (ALP) | Placebo | -2.6 | Standard Deviation 12.5 | Percent change | |
| Double-blind Phase: Absolute Values for Serum ALP, Aspartate Aminotransferase (AST), Alanine Transaminase (ALT) and Gamma-glutamyl Transferase (GGT) Levels | Obeticholic Acid (OCA) 10 Milligrams (mg) | ALP, Baseline | 294.4 | Standard Deviation 149.4 | Units per liter |
| Double-blind Phase: Absolute Values for Serum ALP, Aspartate Aminotransferase (AST), Alanine Transaminase (ALT) and Gamma-glutamyl Transferase (GGT) Levels | OCA 25 mg | ALP, Baseline | 290.0 | Standard Deviation 123.6 | Units per liter |
| Double-blind Phase: Absolute Values for Serum ALP, Aspartate Aminotransferase (AST), Alanine Transaminase (ALT) and Gamma-glutamyl Transferase (GGT) Levels | OCA 50 mg | ALP, Baseline | 289.5 | Standard Deviation 106.2 | Units per liter |
| Double-blind Phase: Absolute Values for Serum ALP, Aspartate Aminotransferase (AST), Alanine Transaminase (ALT) and Gamma-glutamyl Transferase (GGT) Levels | Placebo | ALP, Baseline | 275.2 | Standard Deviation 102.7 | Units per liter |
| Double-blind Phase: Absolute Values for Serum ALP, Aspartate Aminotransferase (AST), Alanine Transaminase (ALT) and Gamma-glutamyl Transferase (GGT) Levels | Obeticholic Acid (OCA) 10 Milligrams (mg) | ALP, Day 15 | 247.6 | Standard Deviation 117.9 | Units per liter |
| Double-blind Phase: Absolute Values for Serum ALP, Aspartate Aminotransferase (AST), Alanine Transaminase (ALT) and Gamma-glutamyl Transferase (GGT) Levels | OCA 25 mg | ALP, Day 15 | 239.3 | Standard Deviation 113.6 | Units per liter |
1 to 10 of 568Source ClinicalTrials.gov
See all 568 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Phase (Day 1 to Day 85) | STARTED | Obeticholic Acid (OCA) 10 Milligrams (mg) | 38 | |
| Double-Blind Phase (Day 1 to Day 85) | STARTED | OCA 25 mg | 48 | |
| Double-Blind Phase (Day 1 to Day 85) | STARTED | OCA 50 mg | 41 | |
| Double-Blind Phase (Day 1 to Day 85) | STARTED | Placebo | 38 | |
| Double-Blind Phase (Day 1 to Day 85) | STARTED | LTSE OCA Total | 0 | |
| Double-Blind Phase (Day 1 to Day 85) | COMPLETED | Obeticholic Acid (OCA) 10 Milligrams (mg) | 32 | |
| Double-Blind Phase (Day 1 to Day 85) | COMPLETED | OCA 25 mg | 42 | |
| Double-Blind Phase (Day 1 to Day 85) | COMPLETED | OCA 50 mg | 25 | |
| Double-Blind Phase (Day 1 to Day 85) | COMPLETED | Placebo | 37 | |
| Double-Blind Phase (Day 1 to Day 85) | COMPLETED | LTSE OCA Total | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events185
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 | Obeticholic Acid (OCA) 10 Milligrams (mg) | 18 | 38 | 23 |
| other | Pruritus | Skin and subcutaneous tissue disorders | OCA 25 mg | 41 | 48 | 52 |
| other | Pruritus | Skin and subcutaneous tissue disorders | OCA 50 mg | 33 | 41 | 60 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Placebo | 19 | 38 | 21 |
| other | Pruritus | Skin and subcutaneous tissue disorders | LTSE OCA Total | 68 | 78 | |
| other | Dry Eye | Eye disorders | Obeticholic Acid (OCA) 10 Milligrams (mg) | 0 | 38 | 0 |
| other | Dry Eye | Eye disorders | OCA 25 mg | 3 | 48 | 3 |
| other | Dry Eye | Eye disorders | OCA 50 mg | 2 | 41 | 2 |
| other | Dry Eye | Eye disorders | Placebo | 1 | 38 | 1 |
| other | Dry Eye | Eye disorders | LTSE OCA Total | 0 | 78 |
1 to 10 of 185Source ClinicalTrials.gov
See all 185 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Obeticholic Acid (OCA) 10 Milligrams (mg) | 0 | 38 |
| Total, all-cause mortality | OCA 25 mg | 0 | 48 |
| Total, all-cause mortality | OCA 50 mg | 0 | 41 |
| Total, all-cause mortality | Placebo | 0 | 38 |
| Total, all-cause mortality | LTSE OCA Total | 0 | 78 |
| Total, other adverse events | Obeticholic Acid (OCA) 10 Milligrams (mg) | 34 | 38 |
| Total, other adverse events | OCA 25 mg | 47 | 48 |
| Total, other adverse events | OCA 50 mg | 41 | 41 |
| Total, other adverse events | Placebo | 32 | 38 |
| Total, other adverse events | LTSE OCA Total | 76 | 78 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25500425 | DERIVED |
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
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00550862
GET https://conductscience.org/api/trials/v1/NCT00550862/registered?page=2