Trial · NCT02287779
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Hematology | From the start of the study drug administration up to 9 days after the last dose of study drug administration | Safety analysis set included all participants for whom a randomization number was assigned and who had taken \>= 1 dose of IMP. | participants | NUMBER |
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Fat Soluble Vitamins (Vitamin A, D, & E) | From the start of the study drug administration up to 9 days after the last dose of study drug administration | Safety analysis set. | participants | NUMBER |
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Lipid Panel | From the start of the study drug administration up to 9 days after the last dose of study drug administration | Safety analysis set. | participants | NUMBER |
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Thyroid Hormone Panel | From the start of the study drug administration up to 9 days after the last dose of study drug administration | Safety analysis set. | participants | NUMBER |
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Coagulation | From the start of the study drug administration up to 9 days after the last dose of study drug administration | Safety analysis set. | participants | NUMBER |
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Chemistry | From the start of the study drug administration up to 9 days after the last dose of study drug administration | Safety analysis set | participants | NUMBER |
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Urinalysis Parameters | From the start of the study drug administration up to 9 days after the last dose of study drug administration | Safety analysis set. | participants | NUMBER |
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs | From the start of the study drug administration up to 9 days after the last dose of study drug administration | Safety analysis set. | participants | NUMBER |
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Electrocardiogram (12-lead) | From the start of the study drug administration up to 9 days after the last dose of study drug administration | Safety analysis set. | participants | NUMBER |
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) | From the start of the study drug administration up to 9 days after the last dose of study drug administration | Safety analysis set. | participants | NUMBER |
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Who Discontinued From the Study | From the start of the study drug administration up to 9 days after the last dose of study drug administration | Safety analysis set. | participants | NUMBER |
| SECONDARY | Average Total Fecal Bile Acid (FBA) Concentration | Day -2 up to Day 14 | Pharmacodynamic set consisted of all participant in the safety analysis set for whom the primary pharmacodynamic data were considered sufficient and interpretable. | nanomoles*gram per liter | MEAN |
| SECONDARY | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day -1 to Day 15 | Pharmacodynamic set. | nanogram per milliliter | MEAN |
| SECONDARY | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2 to Day 14 | Pharmacodynamic set. | participants | NUMBER |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of Volixibat | Day 1 to Day 14 | Pharmacokinetic set consisted of all participants in the safety analysis set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Due to minimal absorption of volixibat no participant had sufficient and interpretable primary pharmacokinetic data. | ||
| SECONDARY | Area Under the Plasma Concentration-Time Curve (AUC) of Volixibat (SHP626) | Day 1 to Day 14 | Pharmacokinetic set. Due to minimal absorption of volixibat no participant had sufficient and interpretable primary pharmacokinetic data. |
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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GET https://conductscience.org/api/trials/v1/NCT02287779/outcomes