Trial · NCT02160782
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Week 18 to Week 22 in Fasting sBA Levels in Participants Who Had a Reduction in sBA ≥50% From Baseline to Week 12 or Week 18 | Week 18 to Week 22 | The primary efficacy endpoint of this study was the mean change from Week 18 to Week 22 (the RWD period) of fasting sBA levels in participants who had a reduction in sBA ≥50% from baseline to Week 12 or Week 18 (Modified Intent-to-Treat \[MITT\] Population). Five participants in the MRX group and 10 participants in the placebo group met the prespecified sBA reduction criteria. |
| Secondary | Change From Baseline to Week 18 in Fasting sBA Levels | Baseline to Week 18 | This secondary efficacy endpoint is the mean change from baseline to Week 18 in fasting sBA levels |
| Secondary | Change From Baseline to Week 18 in Pruritus as Measured by ItchRO (Obs) | Baseline to Week 18 | This secondary efficacy endpoint is the change from baseline to Week 18 in pruritus as measured by ItchRO(Obs) weekly average morning score. ItchRO scores range from 0 to 4; the higher score indicates increasing itch severity (0 = none; 4 = very severe). |
| Secondary | Change From Baseline to Week 18 in Pruritus as Measured by ItchRO (Pt) | Baseline to Week 18 | This secondary efficacy endpoint is the change from baseline to Week 18 in pruritus as measured by ItchRO(Pt) weekly average morning score |
| Secondary | Change From Week 18 to Week 22 in Pruritus as Measured by ItchRO(Obs) | Week 18 to Week 22 | This secondary efficacy endpoint is the change from Week 18 to Week 22 in pruritus as measured by ItchRO(Obs) weekly average morning score. ItchRO scores range from 0 to 4; the higher score indicates increasing itch severity (0 = none; 4 = very severe). |
| Secondary | Change From Week 18 to Week 22 in Pruritus as Measured by ItchRO(Pt) | Week 18 to Week 22 | This secondary efficacy endpoint is the change from Week 18 to Week 22 in pruritus as measured by ItchRO(Pt) weekly average morning score. ItchRO scores range from 0 to 4; the higher score indicates increasing itch severity (0 = none; 4 = very severe). |
| Secondary | Change From Baseline to Week 18 in Alkaline Phosphatase | Baseline to Week 18 | This secondary efficacy endpoint is the mean change from baseline to Week 18 in ALP |
| Secondary | Change From Week 18 to Week 22 in Alkaline Phosphatase | Week 18 to Week 22 | This secondary efficacy endpoint is the mean change from Week 18 to Week 22 in ALP |
| Secondary | Change From Baseline to Week 18 in Alanine Aminotransferase | Baseline to Week 18 | This secondary efficacy endpoint is the mean change from baseline to Week 18 in ALT |
| Secondary | Change From Week 18 to Week 22 in Alanine Aminotransferase | Week 18 to Week 22 | This secondary efficacy endpoint is the mean change from Week 18 to Week 22 in alanine aminotransferase (ALT) |
| Secondary | Change From Baseline to Week 18 in Total Bilirubin | Baseline to Week 18 | This secondary efficacy endpoint is the mean change from baseline to Week 18 in total bilirubin |
| Secondary | Change From Week 18 to Week 22 in Total Bilirubin | Week 18 to Week 22 | This secondary efficacy endpoint is the mean change from Week 18 to Week 22 in total bilirubin |
| Secondary | Change From Baseline to Week 18 in Direct Bilirubin | Baseline to Week 18 | This secondary efficacy endpoint is the mean change from baseline to Week 18 in direct bilirubin |
| Secondary | Change From Week 18 to Week 22 in Direct Bilirubin | Week 18 to Week 22 | This secondary efficacy endpoint is the mean change from Week 18 to Week 22 in direct bilirubin |
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
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GET https://conductscience.org/api/trials/v1/NCT02160782/registered