Trial · NCT03663582
Outcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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) | ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit. | Liter per week (L/Week) | MEAN |
| 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) | ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit. | Percent change | MEAN |
| 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 | ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit. Here, number of participants analyzed refer to the number of participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| 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 | ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit. Here, number of participants analyzed refer to the number of participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| 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) | ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit. | Percentage of participants | NUMBER |
| 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) | ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit. | Days per Week | MEAN |
| PRIMARY | Change From Baseline in Plasma Citrulline Levels at End of Treatment/Early Termination (EOT/ET) | Baseline, EOT/ET (up to Week 28) | ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit. | Micromoles (mcmol) | MEAN |
| PRIMARY | Number of Participants Who Were Completely Weaned Off Parenteral Support (PS) at Week 24/End of Treatment (EOT) | Week 24/EOT | ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | Pharmacokinetic (PK) population included all participants who received at least 1 dose of teduglutide and had at least 1 evaluable post-dose pharmacokinetic concentration value. | Hour*nanogram per milliliter (h*ng/mL) | MEAN |
| 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 | PK population included all participants who received at least 1 dose of teduglutide and had at least 1 evaluable post-dose pharmacokinetic concentration value. | Nanograms per milliliter (ng/mL) | MEAN |
| 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 | PK population included all participants who received at least 1 dose of teduglutide and had at least 1 evaluable post-dose pharmacokinetic concentration value. | Hour | MEDIAN |
| 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 | PK population included all participants who received at least 1 dose of teduglutide and had at least 1 evaluable post-dose pharmacokinetic concentration value. Here, the number of participants analyzed refer to the number of participants evaluable for this outcome measure. | Hour | MEDIAN |
| 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 | PK population included all participants who received at least 1 dose of teduglutide and had at least 1 evaluable post-dose pharmacokinetic concentration value. Here, the number of participants analyzed refer to the number of participants evaluable for this outcome measure. | Milliliter per hour (mL/h) | MEAN |
| 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 | PK population included all participants who received at least 1 dose of teduglutide and had at least 1 evaluable post-dose pharmacokinetic concentration value. Here, the number of participants analyzed refer to the number of participants evaluable for this outcome measure. | Milliliter (mL) | MEAN |
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From start of study drug administration up to EOT/ET (up to Week 28) | Safety population included all participants in the ITT population who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| 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) | Safety population included all participants in the ITT population who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Blood Pressure at End of Treatment/Early Termination (EOT/ET) | Baseline, EOT/ET (up to Week 28) | Safety population included all participants in the ITT population who received at least 1 dose of study drug. | Millimetre of mercury (mmHg) | MEAN |
| PRIMARY | Change From Baseline in Pulse Rate at End of Treatment/Early Termination (EOT/ET) | Baseline, EOT/ET (up to Week 28) | Safety population included all participants in the ITT population who received at least 1 dose of study drug. | Beats per minute (beats/min) | MEAN |
| PRIMARY | Change From Baseline in Body Temperature at End of Treatment/Early Termination (EOT/ET) | Baseline, EOT/ET (up to Week 28) | Safety population included all participants in the ITT population who received at least 1 dose of study drug. | Degree Celsius | MEAN |
| PRIMARY | Change From Baseline in Hemoglobin at End of Treatment/Early Termination (EOT/ET) | Baseline, EOT/ET (up to Week 28) | Safety population included all participants in the ITT population who received at least 1 dose of study drug. | Gram per liter (g/L) | MEAN |
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/NCT03663582/outcomes