Trial · NCT03566238
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With at Least a 70% Reduction in Fasting Serum Bile Acid (s-BA) Concentration From Baseline to the End of Treatment or Reaching a Level <=70 Micromoles Per Liter (Mcmol/L) After 24 Weeks of Treatment | From Baseline (Day 1) up to Week 24 | The FAS included all randomized participants who received at least 1 dose of study treatment. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Positive Pruritus Assessments at the Participant Level Based on the Albireo Observer-Reported Outcome (ObsRO) Instrument Over the 24-Week Treatment Period | From Baseline (Day 1) up to Week 24 | The FAS included all randomized participants who received at least 1 dose of study treatment. | percentage of assessments | MEAN |
| SECONDARY | Change From Baseline in Fasting Serum Bile Acid at Weeks 12 and 24 | Baseline (Day 1) and Weeks 12 and 24 | The FAS included all randomized participants who received at least 1 dose of study treatment. Only participants with data collected at Baseline and Weeks 12 and 24 are reported. | mcmol/L | MEAN |
| SECONDARY | Change From Baseline in Serum Alanine Aminotransferase (ALT) Concentration at Weeks 12 and 24 | Baseline (Day 1) and Weeks 12 and 24 | The FAS included all randomized participants who received at least 1 dose of study treatment. Only participants with data collected at Baseline and Weeks 12 and 24 are reported. | units/L | MEAN |
| SECONDARY | Change From Baseline in Growth Parameters at Weeks 12 and 24 | Baseline (Day 1) and Weeks 12 and 24 | The FAS included all randomized participants who received at least 1 dose of study treatment. Only participants with data collected at Baseline and Weeks 12 and 24 are reported. | z-score | MEAN |
| SECONDARY | Percentage of Responders for Pruritus Assessments Based on Bi-Weekly and Monthly Scores Using the Albireo Observer-Reported Outcome Instrument at Weeks 12 and 24 | Weeks 12 and 24 | The FAS included all randomized participants who received at least 1 dose of study treatment. Only participants with data collected at specific timepoints are reported. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Sleep Parameters Based on the Albireo Observer-reported Outcome Instrument Over the 24-Week Treatment Period | Baseline (Day 1) and Weeks 1 to 4, Weeks 5 to 8, Weeks 9 to 12, Weeks 13 to 16, Weeks 17 to 20, and Weeks 21 to 24 | The FAS included all randomized participants who received at least 1 dose of study treatment. Only participants with data collected at specific timepoints are reported. | percentage of days | MEAN |
| SECONDARY | Change From Baseline in Sleep Parameters Based on the Albireo Patient-Reported Outcome (PRO) Instrument Over the 24-Week Treatment Period | Baseline (Day 1) and Weeks 1 to 4, Weeks 5 to 8, Weeks 9 to 12, Weeks 13 to 16, Weeks 17 to 20, and Weeks 21 to 24 | The FAS included all randomized participants who received at least 1 dose of study treatment. Only participants with data collected at specific timepoints are reported. | scores on a scale | MEAN |
| SECONDARY | Percentage of Individual Assessments Meeting the Definition of a Positive Pruritus Assessment at the Participant Level Using the Albireo ObsRO Instrument Over the 24-Week Treatment Period | From Baseline (Day 1) up to Week 24 | The FAS included all randomized participants who received at least 1 dose of study treatment. | percentage of assessments | MEAN |
| SECONDARY | Percentage of Individual Assessments Meeting the Definition of a Positive Pruritus Assessment at the Participant Level Using the Albireo PRO Instrument Over the 24-Week Treatment Period | From Baseline (Day 1) up to Week 24 | The FAS included all randomized participants who received at least 1 dose of study treatment. | percentage of assessments | MEAN |
| SECONDARY | Percentage of Individual Assessments Meeting the Definition of a Positive Pruritus Assessment at the Participant Level Using the Albireo ObsRO Instrument Over the 24-Week Treatment Period | Baseline (Day 1) and Weeks 1 to 4, Weeks 5 to 8, Weeks 9 to 12, Weeks 13 to 16, Weeks 17 to 20, and Weeks 21 to 24 | The FAS included all randomized participants who received at least 1 dose of study treatment. Only participants with data collected at specific timepoints are reported. | percentage of assessments | MEAN |
| SECONDARY | Number of Participants Underwent Biliary Diversion Surgery and Liver Transplantation | From Baseline (Day 1) up to Week 24 | The FAS included all randomized participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Achieved Positive Pruritus Assessment for >50% of the Time Based on the Albireo ObsRO and PRO Instruments Over the 24-Week Treatment Period | From Baseline (Day 1) up to Week 24 | The FAS included all randomized participants who received at least 1 dose of study treatment. Only participants with data collected for specific instrument are reported. | Participants | COUNT_OF_PARTICIPANTS |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03566238/outcomes