Trial · NCT03659916
Outcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Serum Bile Acids | Baseline and Week 72 | The FAS consisted of all participants who had received at least 1 dose of the study treatment. Only participants with data collected at specified timepoints are reported. | micromole per liter (µmol/L) | MEAN |
| PRIMARY | Proportion of Positive Pruritus Assessments at the Participant Level Over 72-Week Using the Albireo Observer-Reported Outcome (ObsRo) Instrument | Baseline and Week 72 | The FAS consisted of all participants who had received at least 1 dose of the study treatment. Only participants with data collected at Baseline and Week 72 are reported. | proportion of pruritus-participant-level | MEAN |
| SECONDARY | Proportion of Positive Pruritus Assessments at the Participant Level Using the Albireo ObsRo Instrument From Weeks 0-4, 0-12, 0-22, 0-24, 0-36, 0-46, 0-48, 0-60, and 0-70 | Weeks 0-4, Weeks 0-12, Weeks 0-22, Weeks 0-24, Weeks 0-36, Weeks 0-46, Weeks 0-48, Weeks 0-60, and Weeks 0-70 | The FAS consisted of all participants who had received at least 1 dose of the study treatment. Only participants with data collected at specified timepoints are reported. | proportion of pruritus-participant-level | MEAN |
| SECONDARY | Change From Baseline in Serum Bile Acids at Weeks 4, 12, 22, 24, 36, 46, 48, 60, 70, and 72 | Baseline and Weeks 4, 12, 22, 24, 36, 46, 48, 60, 70, and 72 | The FAS consisted of all participants who had received at least 1 dose of the study treatment. Only participants with data collected at specified timepoints are reported. | µmol/L | MEAN |
| SECONDARY | Proportion of Positive Pruritus Assessments at the Participant Level Using the Albireo ObsRo Instrument From Weeks 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 34-36, 44-46, 47-48, 58-60, 68-70, 71-72, 73-76 | Weeks 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 34-36, 44-46, 47-48, 58-60, 68-70, 71-72, 73-76 | The FAS consisted of all participants who had received at least 1 dose of the study treatment. Only participants with data collected at specified timepoints are reported. | proportion of pruritus-participant-level | MEAN |
| SECONDARY | Proportion of Positive Pruritus Assessments at the Participant Level Using the Albireo ObsRo Instrument (AM Score) | Weeks 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 34-36, 44-46, 47-48, 58-60, 68-70, 71-72, and 73-76 | The FAS consisted of all participants who had received at least 1 dose of the study treatment. Only participants with data collected at specified timepoints are reported. | proportion of pruritus-participant-level | MEAN |
| SECONDARY | Proportion of Positive Pruritus Assessments at the Participant Level Using the Albireo ObsRo Instrument (PM Score) | Weeks 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 34-36, 44-46, 47-48, 58-60, 68-70, 71-72, and 73-76 | The FAS consisted of all participants who had received at least 1 dose of the study treatment. Only participants with data collected at specified timepoints are reported. | proportion of pruritus-participant-level | MEAN |
| SECONDARY | Percentage of Responders for Pruritus Assessments Bi-Weekly (AM and PM) | Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12, 13-14, 15-16, 17-18, 19-20, 21-22, 23-24, 35-36, 47-48, 59-60, and 71-72 | The FAS consisted of all participants who had received at least 1 dose of the study treatment. Only participants with data collected at specified timepoints are reported. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Responders for Pruritus Assessments Monthly (AM and PM) | Weeks 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 34-36, 45-48, 58-60, and 68-72 | The FAS consisted of all participants who had received at least 1 dose of the study treatment. Only participants with data collected at specified timepoints are reported. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Positive Pruritus Assessment for >50% of the Time Based on the Albireo ObsRO (AM and PM) | Week 72 | The FAS consisted of all participants who had received at least 1 dose of the study treatment. Only participants with non-missing value when \>50% were included. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants Who Underwent Biliary Diversion Surgery and Liver Transplantation | Baseline and Weeks 24, 48, and 72 | The FAS consisted of all participants who had received at least 1 dose of the study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Height Z-Scores | Baseline and Weeks 24, 48, 70 and 72 | The FAS consisted of all participants who had received at least 1 dose of the study treatment. Only participants with data collected at specified timepoints are reported. | Z-score | MEDIAN |
| SECONDARY | Change From Baseline in Weight Z-Scores | Baseline and Weeks 24, 48, 70 and 72 | The FAS consisted of all participants who had received at least 1 dose of the study treatment. Only participants with data collected at specified timepoints are reported. | Z-score | MEDIAN |
| SECONDARY | Change From Baseline in Body Mass Index (BMI) Z-Scores | Baseline and Weeks 24, 48, 70 and 72 | The FAS consisted of all participants who had received at least 1 dose of the study treatment. Only participants with data collected at specified timepoints are reported. | Z-score | MEDIAN |
| SECONDARY | Number of Participants With Use of Ursodeoxycholic Acid (UDCA) and/or Rifampicin at Weeks 24, 48, and 72 | Weeks 24, 48, and 72 | The FAS consisted of all participants who had received at least 1 dose of the study treatment. Only participants with data collected at specified timepoints are reported. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline to Week 72 in Pediatric End-Stage Liver Disease (PELD) Score | Baseline and Week 72 | The FAS consisted of all participants who had received at least 1 dose of the study treatment. Only participants with data collected at Baseline and Week 72 are reported. | score on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 72 in Model for End-stage Liver Disease (MELD) Score for Children 12 Years of Age or Older | Baseline and Week 72 | The FAS consisted of all participants who had received at least 1 dose of the study treatment. Only participants 12 years of age or older are included in this analysis and reported. For Cohort 1: Placebo/Odevixibat change from baseline data was not collected as participant was under 12 years old, that aligns with MELD score calculation. | score on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 72 in Aspartate Aminotransferase (AST) to Platelet Ratio Index (APRI) Score | Baseline and Week 72 | The FAS consisted of all participants who had received at least 1 dose of the study treatment. Only participants with data collected at Baseline and Week 72 are reported. | score on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 72 in Fibrosis-4 (Fib-4) Score | Baseline and Week 72 | The FAS consisted of all participants who had received at least 1 dose of the study treatment. Only participants with data collected at Baseline and Week 72 are reported. | score on a scale | 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.
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