| Primary | Absolute Change From Baseline In High-density Lipoprotein (HDL) Cholesterol Concentration | | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Least Squares Mean | 95% Confidence Interval | mmol/L | | Baseline, Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-0.38(-0.51 to -0.24)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | | | | | Mean Difference (Net) | -0.38 | | | 2-Sided | 95 | -0.51 | -0.24 | | | | | Superiority or Other (legacy) | | |
|
| Primary | Absolute Change From Baseline In HDL Particle Size | | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Least Squares Mean | 95% Confidence Interval | nm | | Baseline, Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. |
| |
| Primary | Absolute Change From Baseline In HDL Particle Number | | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Least Squares Mean | 95% Confidence Interval | umol/L | | Baseline, Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. |
| |
| Secondary | Median Change From Baseline In HDL Cholesterol Concentration At Weeks 4, 8, and 12 | | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Median | Inter-Quartile Range | mmol/L | | Baseline, Week 4, Week 8, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. |
| |
| Secondary | Median Change From Baseline In HDL Particle Size At Weeks 4, 8, and 12 | | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Median | Inter-Quartile Range | nm | | Baseline, Week 4, Week 8, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. |
| |
| Secondary | Median Change From Baseline In HDL Particle Number At Weeks 4, 8, and 12 | | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Median | Inter-Quartile Range | umol/L | | Baseline, Week 4, Week 8, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. |
| |
| Secondary | Median Change From Week 8 In HDL Cholesterol Concentration At Week 12 | | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Median | Inter-Quartile Range | mmol/L | | Week 8, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. |
| |
| Secondary | Median Change From Week 8 In HDL Particle Size At Week 12 | | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Median | Inter-Quartile Range | nm | | Week 8, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. |
| |
| Secondary | Median Change From Week 8 In HDL Particle Number At Week 12 | | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Median | Inter-Quartile Range | umol/L | | Week 8, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. |
| |
| Secondary | Maximum Plasma Concentration (Cmax) Of OCA And Conjugates | Results are reported in nanograms per milliliter (ng/mL). | The PK Population was comprised of all subjects who had at least 1 confirmed analyzable fasting sample at Week 8 and who did not have any major protocol deviations that potentially affected exposure levels. The PK Population was used for the OCA PK and bile acid analyses. | Posted | | Mean | Standard Deviation | ng/mL | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. |
| |
| Secondary | Time To Reach Cmax (Tmax) For OCA And Conjugates | Results are reported in hours (h). | The PK Population was comprised of all subjects who had at least 1 confirmed analyzable fasting sample at Week 8 and who did not have any major protocol deviations that potentially affected exposure levels. The PK Population was used for the OCA PK and bile acid analyses. | Posted | | Median | Full Range | h | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. |
| |
| Secondary | Area Under The Concentration-time Curve From Hour 0 To Last Sampling Time (Hour 6) (AUC0-6) For OCA And Conjugates | Results are reported in hour*nanograms per milliliter (h*ng/mL). | The PK Population was comprised of all subjects who had at least 1 confirmed analyzable fasting sample at Week 8 and who did not have any major protocol deviations that potentially affected exposure levels. The PK Population was used for the OCA PK and bile acid analyses. | Posted | | Mean | Standard Deviation | h*ng/mL | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. |
| |
| Secondary | Median Change From Baseline In Total Cholesterol | | Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline. | Posted | | Median | Inter-Quartile Range | mmol/L | | Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose | | | | ID | Title | Description |
|---|
| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. | | OG001 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
| |
| Secondary | Median Change From Baseline In Total Triglycerides | | Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline. | Posted | | Median | Inter-Quartile Range | mmol/L | | Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose | | | | ID | Title | Description |
|---|
| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. | | OG001 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
| |
| Secondary | Median Change From Baseline In Low-density Lipoprotein (LDL) Cholesterol (Direct) | | Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline. | Posted | | Median | Inter-Quartile Range | mmol/L | | Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose | | | | ID | Title | Description |
|---|
| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. | | OG001 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
| |
| Secondary | Median Change From Baseline In LDL Particle Size | | Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline. | Posted | | Median | Inter-Quartile Range | nm | | Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose | | | | ID | Title | Description |
|---|
| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. | | OG001 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
| |
| Secondary | Median Change From Baseline In Total LDL Particles | Results are reported in nanomoles per liter (nmol/L). | Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline. | Posted | | Median | Inter-Quartile Range | nmol/L | | Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose | | | | ID | Title | Description |
|---|
| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. | | OG001 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
| |
| Secondary | Median Change From Baseline In Very Low-density Lipoprotein (VLDL) Cholesterol | Results are reported in milligrams per deciliter (mg/dL). | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Median | 95% Confidence Interval | mg/dL | | Baseline, Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose | | | | ID | Title | Description |
|---|
| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. | | OG001 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
| |
| Secondary | Median Change From Baseline In VLDL Particle Size | | Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline. | Posted | | Median | Inter-Quartile Range | nm | | Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose | | | | ID | Title | Description |
|---|
| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. | | OG001 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
| |
| Secondary | Median Change From Baseline In VLDL Particles | | Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline. | Posted | | Median | Inter-Quartile Range | nmol/L | | Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose | | | | ID | Title | Description |
|---|
| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. | | OG001 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
| |
| Secondary | Median Change From Baseline In Apolipoprotein A1 (ApoA1) | Results are reported in grams per liter (g/L). | Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline. | Posted | | Median | Inter-Quartile Range | g/L | | Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose | | | | ID | Title | Description |
|---|
| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. | | OG001 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
| |
| Secondary | Median Change From Baseline In Apolipoprotein B (ApoB) | | Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline. | Posted | | Median | Inter-Quartile Range | units on a scale | | Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose | | | | ID | Title | Description |
|---|
| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. | | OG001 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
| |
| Secondary | Median Change From Baseline In ApoA1/ApoB Ratio | | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Median | Inter-Quartile Range | Ratio | | Baseline, Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose | | | | ID | Title | Description |
|---|
| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. | | OG001 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
| |
| Secondary | Median Change From Baseline In Apolipoprotein E | | Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose | | | | ID | Title | Description |
|---|
| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. | | OG001 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
| |
| Secondary | Median Change From Baseline In Lipoprotein-a | | Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline. | Posted | | Median | Inter-Quartile Range | umol/L | | Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose | | | | ID | Title | Description |
|---|
| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. | | OG001 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
| |
| Secondary | Median Change From Baseline In Lecithin-cholesterol Acyltransferase Activity | Results are reported in nanomoles/milliliter/hour (nmol/mL/h). | Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline. | Posted | | Median | Inter-Quartile Range | nmol/mL/h | | Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT | | | | ID | Title | Description |
|---|
| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. | | OG001 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
| |
| Secondary | Median Change From Baseline In Cholesteryl Ester Transfer Protein | Results are reported in picomole/milliliter/minute (pmol/mL/min). | Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline. | Posted | | Median | Inter-Quartile Range | pmol/mL/min | | Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT | | | | ID | Title | Description |
|---|
| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. | | OG001 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
| |
| Secondary | Median Change From Baseline In Prebeta-1 HDL Concentration | Results are reported in microgram/milliliter (ug/mL). | Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline. | Posted | | Median | Inter-Quartile Range | ug/mL | | Baseline, Week 4, Week 8/End of Treatment (EOT), Month 6, Month 12, Month 18, Month 24/EOT | | | | ID | Title | Description |
|---|
| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. | | OG001 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
| |
| Secondary | Median Change From Baseline In Macrophage Cholesterol Efflux | Results are reported as a percentage of cholesterol. | Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline. | Posted | | Median | Inter-Quartile Range | percentage of cholesterol | | Baseline, Week 4, Week 8/End of Treatment (EOT), Month 6, Month 12, Month 18, Month 24/EOT | | | | ID | Title | Description |
|---|
| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. | | OG001 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
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| Secondary | Median Change From Baseline In C-reactive Protein | | Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline. | Posted | | Median | Inter-Quartile Range | nmol/L | | Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT | | | | ID | Title | Description |
|---|
| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. | | OG001 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
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| Secondary | Median Change From Baseline In Glycoprotein A | Results are reported in picograms/milliliter (pg/mL). | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Median | Inter-Quartile Range | pg/mL | | Baseline, Week 12, Month 6, Month 12, Month 18, Month 24/EOT | | | | ID | Title | Description |
|---|
| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. | | OG001 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
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| Secondary | Median Change From Baseline In Fibroblast Growth Factor-19 | | Intent-to-treat population, comprised of all enrolled participants who received at least 1 dose of OCA, was used for all efficacy and safety endpoints. The overall number of the participants is the total number of participants who had at least 1 lab measurement at any given timepoint, including the baseline. The number of participants at a given week may be smaller than the overall number of participants, because some patients may have no follow up measurement at that week, or no baseline. | Posted | | Median | Inter-Quartile Range | pg/mL | | Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT | | | | ID | Title | Description |
|---|
| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. | | OG001 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
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| Secondary | Participants With Lipoprotein X | Lipoprotein samples were assessed using nuclear magnetic resonance spectroscopy for the presence/absence of Lipoprotein X. Lipoprotein X sometimes appears with advanced cholestasis and can confound assessment of other lipoprotein concentrations, particularly LDL. | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Count of Participants | | Participants | | Week 12 and Last Dose | | | | ID | Title | Description |
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| OG000 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. | | OG001 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
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| Secondary | Median Change From Baseline In Alkaline Phosphatase | Results are reported in units/Liter (U/L). | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Median | Inter-Quartile Range | U/L | | Baseline, Month 6, Month 12, Month 18, Month 24/EOT | | | | ID | Title | Description |
|---|
| OG000 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
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| Secondary | Median Change From Baseline In Gamma-glutamyl Transferase | | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Median | Inter-Quartile Range | U/L | | Baseline, Month 6, Month 12, Month 18, Month 24/EOT | | | | ID | Title | Description |
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| OG000 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
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| Secondary | Median Change From Baseline In Alanine Aminotransferase | | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Median | Inter-Quartile Range | U/L | | Baseline, Month 6, Month 12, Month 18, Month 24/EOT | | | | ID | Title | Description |
|---|
| OG000 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
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| Secondary | Median Change From Baseline In Aspartate Aminotransferase | | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Median | Inter-Quartile Range | U/L | | Baseline, Month 6, Month 12, Month 18, Month 24/EOT | | | | ID | Title | Description |
|---|
| OG000 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
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| Secondary | Median Change From Baseline In Total And Unconjugated (Direct) Bilirubin | | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Median | Inter-Quartile Range | umol/L | | Baseline, Month 6, Month 12, Month 18, Month 24/EOT | | | | ID | Title | Description |
|---|
| OG000 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
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| Secondary | Median Change From Baseline In Albumin | | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Median | Inter-Quartile Range | g/L | | Baseline, Month 6, Month 12, Month 18, Month 24/EOT | | | | ID | Title | Description |
|---|
| OG000 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
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| Secondary | Median Change From Baseline In Prothrombin Time | Results are reported in seconds (sec). | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Median | Inter-Quartile Range | sec | | Baseline, Month 6, Month 12, Month 18, Month 24/EOT | | | | ID | Title | Description |
|---|
| OG000 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
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| Secondary | Median Change From Baseline In Prothrombin International Normalized Ratio | | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Median | Inter-Quartile Range | ratio | | Baseline, Month 6, Month 12, Month 18, Month 24/EOT | | | | ID | Title | Description |
|---|
| OG000 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
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| Secondary | Median Change From Baseline In Enhanced Liver Fibrosis (ELF) Score | Change in ELF was calculated as ELF score at the end of the study minus ELF score prior to the intervention (at baseline). A decrease in the ELF score was considered good as it reflected a decrease in liver fibrosis, and an increase in ELF score was considered bad as it reflected an increase in liver fibrosis. Change in ELF scores ranged from -0.56 (good) to + 0.68 (bad). | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Median | Inter-Quartile Range | score on a scale | | Baseline, Month 12, Month 24/EOT | | | | ID | Title | Description |
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| OG000 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
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| Secondary | Median Change From Baseline In Hyaluronic Acid | | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Median | Inter-Quartile Range | ng/mL | | Baseline, Month 12, Month 24/EOT | | | | ID | Title | Description |
|---|
| OG000 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
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| Secondary | Median Change From Baseline In Amino-terminal Propeptide Of Type III Procollagen | Results are reported in micrograms/Liter (ug/L). | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Median | Inter-Quartile Range | ug/L | | Baseline, Month 12, Month 24/EOT | | | | ID | Title | Description |
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| OG000 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
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| Secondary | Median Change From Baseline In Tissue Inhibitor Of Metalloproteinases 1 | | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Median | Inter-Quartile Range | ug/L | | Baseline, Month 12, Month 24/EOT | | | | ID | Title | Description |
|---|
| OG000 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
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| Secondary | Median Change From Baseline In Hepatic Stiffness | Results are reported in kilopascal (kPa). | Intent-to-treat was comprised of all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. The number of participants analyzed includes the subjects who were available at the specific time point of analysis. | Posted | | Median | Inter-Quartile Range | kPa | | Baseline, Month 12, Month 24/EOT | | | | ID | Title | Description |
|---|
| OG000 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
| |
| Secondary | Median Change From Baseline In Total Bile Acids | | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Median | Inter-Quartile Range | umol/L | | Baseline, Month 6, Month 12, Month 18, Month 24/EOT | | | | ID | Title | Description |
|---|
| OG000 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
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| Secondary | Median Change From Baseline In Total Endogenous Bile Acid | | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Median | Inter-Quartile Range | umol/L | | Baseline, Month 6, Month 12, Month 18, Month 24/EOT | | | | ID | Title | Description |
|---|
| OG000 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
| | |
| Secondary | Median Change From Baseline In Total UDCA | | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Median | Inter-Quartile Range | umol/L | | Baseline, Month 6, Month 12, Month 18, Month 24/EOT | | | | ID | Title | Description |
|---|
| OG000 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
| | |
| Secondary | Median Change From Baseline In Total Chenodeoxycholic Acid | | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Median | Inter-Quartile Range | umol/L | | Baseline, Month 6, Month 12, Month 18, Month 24/EOT | | | | ID | Title | Description |
|---|
| OG000 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
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| Secondary | Median Change From Baseline In Total Lithocholic Acid | | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Median | Inter-Quartile Range | umol/L | | Baseline, Month 6, Month 12, Month 18, Month 24/EOT | | | | ID | Title | Description |
|---|
| OG000 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
| | |
| Secondary | Median Change From Baseline In Total Cholic Acid | | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Median | Inter-Quartile Range | umol/L | | Baseline, Month 6, Month 12, Month 18, Month 24/EOT | | | | ID | Title | Description |
|---|
| OG000 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
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| Secondary | Median Change From Baseline In Total Deoxycholic Acid | | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Median | Inter-Quartile Range | umol/L | | Baseline, Month 6, Month 12, Month 18, Month 24/EOT | | | | ID | Title | Description |
|---|
| OG000 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
| | |
| Secondary | Absolute Change From Baseline In HDL Cholesterol Concentration | | Intent-to-treat was comprised of all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. The number of participants analyzed includes the subjects who were available at the specific time point of analysis. | Posted | | Least Squares Mean | 95% Confidence Interval | mmol/L | | Baseline, Month 24/EOT | | | | ID | Title | Description |
|---|
| OG000 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
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| Secondary | Absolute Change From Baseline In HDL Particle Size | | Intent-to-treat was comprised of all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. The number of participants analyzed includes the subjects who were available at the specific time point of analysis. | Posted | | Least Squares Mean | 95% Confidence Interval | nm | | Baseline, Month 24/EOT | | | | ID | Title | Description |
|---|
| OG000 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
| |
| Secondary | Absolute Change From Baseline In HDL Particle Number | | Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population. | Posted | | Least Squares Mean | 95% Confidence Interval | umol/L | | Baseline, Month 24/EOT | | | | ID | Title | Description |
|---|
| OG000 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. |
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