Trial · NCT03922321
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Serious AE (SAE), Treatment-related Adverse Event (AE), and Death During the 6-week Treatment Period | from Baseline up to Week 6 | Safety Population: all participants who received at least one dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Findings Related to Vital Signs | up to Week 18 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With a Change From Normal Physical Examination Findings at Baseline to Abnormal Physical Examination Findings at the End of the Study | up to Week 18 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Findings Related to Electrocardiograms (ECGs) | up to Week 18 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percent Change From Baseline in Total Immunoglobulin G (IgG), IgG1, IgG2, IgG3, and IgG4 Levels | Baseline; Week 7; Week 6 and 7 combined | Pharmacodynamic (PD) Population: all participants who had a Baseline PD measurement and at least 1 post-Baseline PD measurement and received at least 1 dose of study drug. Only participants with available data were analyzed. | Percent change | MEAN |
| PRIMARY | Mean Change From Baseline in Levels of Anti-thyroid-stimulating Hormone Receptor (Anti-TSHR) Antibodies at Week 7 | Baseline; Week 7 | PD Population. Only participants with available data were analyzed. | international units/milliliter (IU/mL) | MEAN |
| SECONDARY | Mean Change From Baseline in Proptosis in the Study Eye and Non-study Eye at Week 7 | Baseline; Week 7 | PD Population. Only participants with available data were analyzed. | millimeter (mm) | MEAN |
| SECONDARY | Number of Participants With an Overall Proptosis Response | Up to Week 18 | PD Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Area Under the Concentration-time Curve From Time 0 to 168 Hours (AUC0-168h) of RVT-1401 | Pre-dose; Day 1, Day 3, Day 5, Day 8, Day 15, Day 22, Day 29, Day 36, Day 38, Day 40, Week 7, Week 8 | PK Population: all participants who received at least one dose of study drug and had at least 1 post-dose PK sample assayed for RVT-1401. Only 2 non-Ctrough time point samples were collected after the first dose (on Day 3 and Day 5) and last dose (on Day 38 and Day 40). As a result, having 2 sparse time point samples did not allow to accurately estimate AUC0-168h parameter. | ||
| SECONDARY | Maximum Concentration (Cmax) of RVT-1401 | Pre-dose; Day 1, Day 3, Day 5, Day 8, Day 15, Day 22, Day 29, Day 36, Day 38, Day 40, Week 7, Week 8 | PK Population. PK parameters were not estimated because the sparse PK sampling schedule did not allow for accurate estimates of these parameters. Only 2 non-Ctrough time point samples were collected after the first dose (on Day 3 and Day 5) and last dose (on Day 38 and Day 40). As a result, having 2 sparse time point samples did not allow to accurately estimate Cmax parameter. | ||
| SECONDARY | Serum Concentration at the End of the Dosing Interval (Ctrough) of RVT-1401 | Week 2, Week 3, Week 4, Week 5, Week 6 Day 36, and Week 7 | PK Population. Participants with evaluable data were included for the analysis. | mg/L | MEAN |
| SECONDARY | Number of Participants With Anti-RVT-1401 Antibody and Confirmed Anti-RVT-1401 Antibody at Week 7 | Week 7 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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/NCT03922321/outcomes