Trial · NCT03353454
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Response as Measured by the Observer Itch Reported Outcome (ItchRO[Obs]) | Baseline up to Week 26 | Compare the percentage of participants on active treatment versus (vs.) placebo who meet response criteria which is defined as improvement in before midday (AM) Observer Itch Reported Outcome (ItchRO\[Obs\]) severity decrease from baseline demonstrated on at least 2 of the last 3 study visits. |
| Secondary | Treatment Response as Measured by the Observer Itch Reported Outcome (ItchRO[Obs]) and Serum Bile Acids (sBA) | Baseline up to Week 26 | Compare the percentage of participants on active treatment versus (vs.) placebo who meet response criteria which is defined as improvement in average before midday (AM) Observer Itch Reported Outcome (ItchRO\[Obs\]) severity decrease from baseline and normalization or reduction from baseline sBA demonstrated on at least 2 of the last 3 study visits. |
| Secondary | Normalization or Reduction From Baseline in Serum Bile Acids (sBA) | Baseline up to Week 26 | Compare the percentage of participants on active treatment vs. placebo with normalization or significant reduction from baseline in sBA. |
| Secondary | Change Over Time in Daily Average Itch Reported Outcome (ItchRO[Obs]) Score | Baseline up to Week 26 | Change over time in daily average ItchRO scores will be reported. |
| Secondary | Change Over Time in Before Midday (AM) Itch Reported Outcome (ItchRO[Obs]) Score | Baseline up to Week 26 | Change over time in AM ItchRO scores will be reported. |
| Secondary | Change Over Time in After Midday (PM) Itch Reported Outcome (ItchRO[Obs]) Score | Baseline up to Week 26 | Change over time in PM ItchRO scores will be reported. |
| Secondary | Disappearance of Pruritus as Measured by Observer Itch Reported Outcome (ItchRO[Obs]) | Baseline up to Week 26 | Compare the percentage of participants on active treatment vs. placebo of participants who experience disappearance of pruritus as measured by ItchRO(Obs). |
| Secondary | Improvement in Height | Baseline up to Week 26 | Number of participants on active treatment vs. placebo with a height z-score change from baseline \>0. |
| Secondary | Improvement in Weight | Baseline up to Week 26 | Number of participants on active treatment vs. placebo with a weight z-score change from baseline \>0. |
| Secondary | Change From Baseline in Nutritional Status as Measured by Mid-arm Circumference | Baseline, Week 26 | Compare the change in nutritional status as measured by mid-arm circumference in participants on active treatment vs. placebo. |
| Secondary | Change From Baseline in Nutritional Status as Measured by Triceps Skin Fold | Baseline, Week 26 | Compare the change in nutritional status as measured by triceps skin fold in participants on active treatment vs. placebo. |
| Secondary | Change From Baseline in Clinician Scratch Scale (CSS) | Baseline, Week 26 | Compare the change in Clinician Scratch Scale score in participants on active treatment vs. placebo. |
| Secondary | Change From Baseline in Quality of Life as Measured by Pediatric Quality of Life Inventory (PedsQL) | Baseline, Week 26 | Compare the change from baseline of PedsQL in participants on active treatment vs. placebo. |
| Secondary | Change From Baseline in Quality of Sleep as Measured by Children's Sleep Habits Questionnaire (CSHQ) | Baseline, Week 26 | Compare the change from baseline of CSHQ in participants on active treatment vs. placebo. |
| Secondary | Normalization or Meaningful Reduction From Baseline of Alanine Aminotransferase (ALT) | Baseline up to Week 26 | Number of participants whose ALT normalizes on treatment or has decreased \>=50%. |
| Secondary | Normalization or Meaningful Decrease From Baseline of Total Bilirubin | Baseline up to Week 26 | Number of participants whose total bilirubin normalizes on treatment or has decreased \>=50%. |
| Secondary | Change From Baseline in Biomarkers of Bile Acid Synthesis | Baseline, Week 26 | Change from baseline in biomarkers of bile acid synthesis (serum 7 alpha-hydroxy-4-cholesten-3-one \[C4\]). |
| Secondary | Evaluate the safety of SHP625 | Baseline up to Week 26 | Adverse events, changes in vital signs, laboratory, and other safety parameters will be compared between participants on active treatment vs. placebo. |
| Secondary | Plasma Levels of Maralixibat Over Time | Baseline, Week 6, 10, 14, 18, 22 and 26 | Systemic concentrations of maralixibat in plasma will be assessed. |
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.
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GET https://conductscience.org/api/trials/v1/NCT03353454/registered