Trial · NCT05014672
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in ALP at Week 24 Compared to Baseline | Baseline (Day 1) and Week 24 | Full Analysis Set | ratio | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the PROMIS Short Form-Fatigue 7b Daily | Baseline (Day 1) and Week 24 | Full Analysis Set. This questionnaire was introduced after protocol version 1.0, so patients enrolled under protocol version 1.0 do not have a baseline value and are excluded from the number of participants analyzed. | T-scores | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the Patient's Global Impression of Severity (PGIS) Fatigue | Baseline (Day 1) and Week 24 | Full Analysis Set subjects who have both non-missing baseline and Week 24 results | units on a scale | MEAN |
| SECONDARY | Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the Patient's Global Impression of Change (PGIC) Fatigue | Week 24 | Full Analysis Set | units on a scale | MEAN |
| SECONDARY | Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the PBC-40 Questionnaire (PBC 40) Fatigue Domain | Baseline (Day 1) and Week 24 | Full Analysis Set | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Liver Stiffness at Week 24 Compared to Screening | Screening (Day -28) and Week 24 | Full Analysis Set | ratio | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | Change in Pruritus at Week 24 Compared to Baseline, as Assessed by the Worst Itch Numerical Rating Scale (WI-NRS) | Baseline (Day 1) and Week 24 | Full Analysis Set subjects who have both non-missing baseline and Week 24 results | units on a scale | MEAN |
| SECONDARY | Change in Pruritus at Week 24 Compared to Baseline, as Assessed by the PBC-40 Itch Domain | Baseline (Day 1) and Week 24 | Full Analysis Set subjects who have both non-missing baseline and Week 24 results | units on a scale | MEAN |
| SECONDARY | Change in Pruritus at Week 24 Compared to Baseline, as Assessed by the PGIS Pruritus | Baseline (Day 1) and Week 24 | Full Analysis Set subjects who have both non-missing baseline and Week 24 results | units on a scale | MEAN |
| SECONDARY | Change in Pruritus at Week 24 Compared to Baseline, as Assessed by the PGIC Pruritus | Week 24 | Full Analysis Set | units on a scale | MEAN |
| SECONDARY | Changes in Markers of Cholestasis at Week 24 | Baseline (Day 1) and Week 24 | Full Analysis Set | participants | NUMBER |
| SECONDARY | Change in ALP at Week 24 Compared to Baseline, Where Setanaxib Doses Are Combined | Baseline (Day 1) and Week 24 | Full Analysis Set | ratio | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the PROMIS Short Form-Fatigue 7b Daily, Where Setanaxib Doses Are Combined | Baseline (Day 1) and Week 24 | Full Analysis Set. This questionnaire was introduced after protocol version 1.0, so patients enrolled under protocol version 1.0 do not have a baseline value and are excluded from the number of participants analyzed. | T-scores | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Fatigue at Week 24 Compared to Baseline, as Assessed by the PBC-40 Questionnaire (PBC 40) Fatigue Domain, Where Setanaxib Doses Are Combined | Baseline (Day 1) and Week 24 | Full Analysis Set | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Liver Stiffness at Week 24 Compared to Screening, Where Setanaxib Doses Are Combined | Screening (Day -28) and Week 24 | Full Analysis Set | ratio | GEOMETRIC_LEAST_SQUARES_MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05014672/outcomes