Trial · NCT02160782
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 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 | Primary outcome used the (Modified Intent-to-Treat \[MITT\]Population. The MITT population is defined as participants who had a reduction in sBA ≥50% from baseline to Week 12 or Week 18. Five participants in the MRX group and 10 participants in the placebo group met the prespecified sBA reduction criteria. | μmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 18 in Fasting sBA Levels | Baseline to Week 18 | Values were collected from 31 participants at baseline. Values were collected at Week 18 from 29 of the 31 participants who contributed values at baseline. | μmol/L | MEAN |
| SECONDARY | Change From Baseline to Week 18 in Pruritus as Measured by ItchRO (Obs) | Baseline to Week 18 | Values were collected from 31 participants at baseline. Values were collected at Week 18 from 29 of the 31 participants who contributed values at baseline. | Points | MEAN |
| SECONDARY | Change From Baseline to Week 18 in Pruritus as Measured by ItchRO (Pt) | Baseline to Week 18 | NOTE: 2 participants discontinued prior week 18 and did not provide data. | Points | MEAN |
| SECONDARY | Change From Week 18 to Week 22 in Pruritus as Measured by ItchRO(Obs) | Week 18 to Week 22 | For Maralixibat, n=12 for ItchRO(Obs) weekly average morning score For Placebo, n=16 for ItchRO(Obs) weekly average morning score | Points | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Week 18 to Week 22 in Pruritus as Measured by ItchRO(Pt) | Week 18 to Week 22 | ItchRO(Pt) was completed independently in participants 9 years old or older. Children between the ages of 5 and 8 years old completed the patient instrument with the assistance of their caregiver, if needed. | Points | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 18 in Alkaline Phosphatase | Baseline to Week 18 | Values were collected from 31 participants at baseline. Values were collected at Week 18 from 29 of the 31 participants who contributed values at baseline. | U/L | MEAN |
| SECONDARY | Change From Week 18 to Week 22 in Alkaline Phosphatase | Week 18 to Week 22 | U/L | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline to Week 18 in Alanine Aminotransferase | Baseline to Week 18 | Values were collected from 31 participants at baseline. Values were collected at Week 18 from 29 of the 31 participants who contributed values at baseline. | U/L | MEAN |
| SECONDARY | Change From Week 18 to Week 22 in Alanine Aminotransferase | Week 18 to Week 22 | The difference between treatment groups in change from Week 18 to Week 22 in ALT levels was evaluated using an ANCOVA model with treatment group as a factor, and Week 18 ALT as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the intent-to-treat population, which included all participants who were enrolled, and received at least one dose of study drug. | U/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 18 in Total Bilirubin | Baseline to Week 18 | Open-label period: MRX baseline v Open-label period: MRX Week 18 | mg/dL | MEAN |
| SECONDARY | Change From Week 18 to Week 22 in Total Bilirubin | Week 18 to Week 22 | mg/dL | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline to Week 18 in Direct Bilirubin | Baseline to Week 18 | Values from the open-label period were collected from 31 participants at baseline. Values were collected at Week 18 from 28 of the 31 participants who contributed values at baseline. | mg/dL | MEAN |
| SECONDARY | Change From Week 18 to Week 22 in Direct Bilirubin | Week 18 to Week 22 | mg/dL | LEAST_SQUARES_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
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GET https://conductscience.org/api/trials/v1/NCT02160782/outcomes