Trial · NCT05543174
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Fasting Serum Bile Acid (sBA) Levels From Week 18 to Week 22 | From Week 18 to Week 22 | ITT included all participants who received at least one dose of study drug. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort. | micromoles per liter (mcmol/L) | MEAN |
| SECONDARY | Change in Fasting sBA Levels From Baseline to Week 18 | Baseline to Week 18 | ITT included all participants who received at least one dose of study drug. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort. | mcmol/L | MEAN |
| SECONDARY | Change in Weekly Average Severity of Pruritus Measured by Itch Reported Outcome (ItchRO) (Observer Instrument [Obs]) From Baseline to Week 18 | Baseline to Week 18 | ITT included all participants who received at least one dose of study drug. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort. | score on a scale | MEAN |
| SECONDARY | Change in Weekly Average Morning Severity of Pruritus Measured by Itch Reported Outcome (ItchRO) (Observer Instrument [Obs]) From Baseline to Week 18 | Baseline to Week 18 | ITT included all participants who received at least one dose of study drug. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort. | score on a scale | MEAN |
| SECONDARY | Change in Weekly Average Severity of Pruritus Measured by ItchRO (Obs) From Week 18 to Week 22 | From Week 18 to Week 22 | ITT included all participants who received at least one dose of study drug. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort. | score on a scale | MEAN |
| SECONDARY | Change in Weekly Average Morning Severity of Pruritus Measured by ItchRO (Obs) From Week 18 to Week 22 | From Week 18 to Week 22 | ITT included all participants who received at least one dose of study drug. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort. | score on a scale | MEAN |
| SECONDARY | Change in Weekly Average Severity of Pruritus Measured by ItchRO (Pt) From Baseline to Week 18 | Baseline to Week 18 | ITT included all participants who received at least one dose of study drug. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change in Weekly Average Morning Severity of Pruritus Measured by ItchRO (Pt) From Baseline to Week 18 | Baseline to Week 18 | ITT included all participants who received at least one dose of study drug. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort. | score on a scale | MEAN |
| SECONDARY | Change in Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels From Baseline to Week 18 | Baseline to Week 18 | ITT included all participants who received at least one dose of study drug. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort. | Units per liter (U/L) | MEAN |
| SECONDARY | Change in Bilirubin (Total and Direct) Levels From Baseline to Week 18 | Baseline to Week 18 | ITT included all participants who received at least one dose of study drug. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort. | mcmol/L | MEAN |
| SECONDARY | Change in Weekly Average Severity of Pruritus Measured by ItchRO (Pt) From Week 18 to Week 22 | From Week 18 to 22 | ITT included all participants who received at least one dose of study drug. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort. | score on a scale | MEAN |
| SECONDARY | Change in Weekly Average Morning Severity of Pruritus Measured by ItchRO (Pt) From Week 18 to Week 22 | From Week 18 to 22 | ITT included all participants who received at least one dose of study drug. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort. | score on a scale | MEAN |
| SECONDARY | Change in ALT and ALP Levels From Week 18 to 22 | From Week 18 to 22 | ITT included all participants who received at least one dose of study drug. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort. | U/L | MEAN |
| SECONDARY | Change in Bilirubin (Total and Direct) Levels From Week 18 to 22 | From Week 18 to 22 | ITT included all participants who received at least one dose of study drug. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort. | mcmol/L | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT05543174/outcomes