Trial · NCT03663582
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment/Early Termination (EOT/ET) | Baseline, EOT/ET (up to Week 28) | Change from baseline in weekly PS volume at EOT/ET was reported. |
| Primary | Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment/Early Termination (EOT/ET) | Baseline, EOT/ET (up to Week 28) | Percent change from baseline in weekly PS volume at EOT/ET was reported. |
| Primary | Percentage of Participants Who Achieved at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume at Week 20 | Baseline, Week 20 | Percentage of participants who achieved at least 20% reduction from baseline in weekly PS volume at Week 20 was reported. |
| Primary | Percentage of Participants Who Achieved at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume at Week 24 | Baseline, Week 24 | Percentage of participants who achieved at least 20% reduction from baseline in weekly PS volume at Week 24 was reported. |
| Primary | Percentage of Participants Who Achieved at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) at End of Treatment/Early Termination (EOT/ET) | Baseline, EOT/ET (up to Week 28) | Percentage of participants who achieve at least 20% reduction from baseline in weekly PS at EOT/ET was reported. |
| Primary | Change From Baseline in Days Per Week of Parenteral Support (PS) at End of Treatment/Early Termination (EOT/ET) | Baseline, EOT/ET (up to Week 28) | Change from baseline in days per week of PS at EOT/ET was reported. |
| Primary | Change From Baseline in Plasma Citrulline Levels at End of Treatment/Early Termination (EOT/ET) | Baseline, EOT/ET (up to Week 28) | Plasma citrulline levels were measured as a biomarker of enterocyte mass. Change from baseline in plasma citrulline levels up to EOT/ET was reported. |
| Primary | Number of Participants Who Were Completely Weaned Off Parenteral Support (PS) at Week 24/End of Treatment (EOT) | Week 24/EOT | Number of participants who were completely weaned off PS at Week 24/EOT was reported. |
| Primary | Area Under the Plasma Concentration-Time Curve From Zero to the Last Measurable Concentration (AUC0-t) of Teduglutide | Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours Post-dose on Day 1; Pre-dose, 1, 2 hours Post-dose on Week 4 or Week 12 | AUC0-t of teduglutide was reported. |
| Primary | Maximum Plasma Concentration (Cmax) of Teduglutide | Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours Post-dose on Day 1; Pre-dose, 1, 2 hours Post-dose on Week 4 or Week 12 | Cmax of teduglutide was reported. |
| Primary | Time to Maximum Plasma Concentration (Tmax) of Teduglutide | Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours Post-dose on Day 1; Pre-dose, 1, 2 hours Post-dose on Week 4 or Week 12 | Tmax of teduglutide was reported. |
| Primary | Terminal-phase Half-life (T1/2) of Teduglutide | Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours Post-dose on Day 1; Pre-dose, 1, 2 hours Post-dose on Week 4 or Week 12 | T1/2 of teduglutide was reported. |
| Primary | Apparent Clearance (CL/F) of Teduglutide | Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours Post-dose on Day 1; Pre-dose, 1, 2 hours Post-dose on Week 4 or Week 12 | CL/F of teduglutide was reported. |
| Primary | Apparent Volume of Distribution (Vz/F) of Teduglutide | Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours Post-dose on Day 1; Pre-dose, 1, 2 hours Post-dose on Week 4 or Week 12 | Vz/F of teduglutide was reported. |
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From start of study drug administration up to EOT/ET (up to Week 28) | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs whose onset occurred, severity worsened, or intensity increased after receiving the study medication. |
| Primary | Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG) | From start of study drug administration up to EOT/ET (up to Week 28) | 12-lead ECG was performed at the study center after the participant has been resting for at least 5 minutes. Number of participants with clinically significant abnormalities in 12-Lead ECG was reported. |
| Primary | Change From Baseline in Blood Pressure at End of Treatment/Early Termination (EOT/ET) | Baseline, EOT/ET (up to Week 28) | Change from baseline in systolic and diastolic blood pressure at EOT/ET was reported. |
| Primary | Change From Baseline in Pulse Rate at End of Treatment/Early Termination (EOT/ET) | Baseline, EOT/ET (up to Week 28) | Change from baseline in pulse rate at EOT/ET was reported. |
| Primary | Change From Baseline in Body Temperature at End of Treatment/Early Termination (EOT/ET) | Baseline, EOT/ET (up to Week 28) | Change from baseline in body temperature at EOT/ET was reported. |
| Primary | Change From Baseline in Hemoglobin at End of Treatment/Early Termination (EOT/ET) | Baseline, EOT/ET (up to Week 28) | Change from baseline in hemoglobin at EOT/ET was reported. |
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/NCT03663582/registered