Trial · NCT03566238
Results by group399
Each measurement the trial posted, group by group, in the words and numbers it posted.
1 to 20 of 399
Download this page as JSON| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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 | Placebo | 0 | 95% Confidence Interval 0.00 to 16.84 | percentage of participants | |
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 | A4250 Low Dose | 43.5 | 95% Confidence Interval 23.19 to 65.51 | percentage of participants | |
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 | A4250 High Dose | 21.1 | 95% Confidence Interval 6.05 to 45.57 | percentage of participants | |
| Percentage of Positive Pruritus Assessments at the Participant Level Based on the Albireo Observer-Reported Outcome (ObsRO) Instrument Over the 24-Week Treatment Period | Placebo | 28.74 | Standard Error 5.209 | percentage of assessments | |
| Percentage of Positive Pruritus Assessments at the Participant Level Based on the Albireo Observer-Reported Outcome (ObsRO) Instrument Over the 24-Week Treatment Period | A4250 Low Dose | 58.31 | Standard Error 6.205 | percentage of assessments | |
| Percentage of Positive Pruritus Assessments at the Participant Level Based on the Albireo Observer-Reported Outcome (ObsRO) Instrument Over the 24-Week Treatment Period | A4250 High Dose | 47.69 | Standard Error 8.110 | percentage of assessments | |
| Change From Baseline in Fasting Serum Bile Acid at Weeks 12 and 24 | Placebo | Week 12 | 7.44 | Standard Error 24.588 | mcmol/L |
| Change From Baseline in Fasting Serum Bile Acid at Weeks 12 and 24 | A4250 Low Dose | Week 12 | -113.70 | Standard Error 38.011 | mcmol/L |
| Change From Baseline in Fasting Serum Bile Acid at Weeks 12 and 24 | A4250 High Dose | Week 12 | -106.44 | Standard Error 41.201 | mcmol/L |
| Change From Baseline in Fasting Serum Bile Acid at Weeks 12 and 24 | Placebo | Week 24 | 18.64 | Standard Error 31.559 | mcmol/L |
| Change From Baseline in Fasting Serum Bile Acid at Weeks 12 and 24 | A4250 Low Dose | Week 24 | -145.03 | Standard Error 41.951 | mcmol/L |
| Change From Baseline in Fasting Serum Bile Acid at Weeks 12 and 24 | A4250 High Dose | Week 24 | -72.90 | Standard Error 52.617 | mcmol/L |
| Change From Baseline in Serum Alanine Aminotransferase (ALT) Concentration at Weeks 12 and 24 | Placebo | Week 12 | 1.7 | Standard Error 10.50 | units/L |
| Change From Baseline in Serum Alanine Aminotransferase (ALT) Concentration at Weeks 12 and 24 | A4250 Low Dose | Week 12 | -25.9 | Standard Error 23.36 | units/L |
| Change From Baseline in Serum Alanine Aminotransferase (ALT) Concentration at Weeks 12 and 24 | A4250 High Dose | Week 12 | -13.8 | Standard Error 19.42 | units/L |
| Change From Baseline in Serum Alanine Aminotransferase (ALT) Concentration at Weeks 12 and 24 | Placebo | Week 24 | 3.7 | Standard Error 4.95 | units/L |
| Change From Baseline in Serum Alanine Aminotransferase (ALT) Concentration at Weeks 12 and 24 | A4250 Low Dose | Week 24 | -27.9 | Standard Error 17.97 | units/L |
| Change From Baseline in Serum Alanine Aminotransferase (ALT) Concentration at Weeks 12 and 24 | A4250 High Dose | Week 24 | -25.3 | Standard Error 22.47 | units/L |
| Change From Baseline in Growth Parameters at Weeks 12 and 24 | Placebo | Height deficit: Week 12 | -0.03 | Standard Error 0.127 | z-score |
| Change From Baseline in Growth Parameters at Weeks 12 and 24 | A4250 Low Dose | Height deficit: Week 12 | 0.01 | Standard Error 0.108 | z-score |
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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