Trial · NCT07901933
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Treatment-Emergent Adverse Events (TEAEs) | From first administration of study intervention through the end of study participation, around Day 36. | Number and percentage of participants with at least one (TEAE). An adverse event (AE) is any untoward medical occurrence in a participant, whether or not considered related to the study intervention. An AE is considered a treatment-emergent AE (TEAE) if the AE begins or worsens after the first dose of study intervention and on or before the last study visit. |
| Primary | Incidence of Serious TEAEs | From first administration of study intervention through the end of study participation, around Day 36. | Number and percentage of participants with at least one serious treatment-emergent adverse event (TEAE). A serious AE (SAE) is defined as any AE that, at any dose, meets one or more of the following criteria: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; results in a congenital anomaly or birth defect; or any important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above. |
| Primary | Incidence of Clinically Significant Changes in Physical Examination | From first administration of study intervention through the end of study participation, around Day 36. | The investigator assesses the clinical significance of changes in physical examination findings. |
| Primary | Incidence of Clinically Significant Changes in Safety Laboratory Values | From first administration of study intervention through the end of study participation, around Day 36. | Safety laboratory evaluations include blood counts, serum chemistries, coagulation studies and urinalyses. Determination of clinical significance is based on investigator discretion. |
| Primary | Incidence of Clinically Significant Changes in Vital Signs | From first administration of study intervention through the end of study participation, around Day 36 | Vital signs include heart rate, respiratory rate, blood pressure, and temperature. Determination of clinical significance is based on investigator discretion. |
| Primary | Incidence of Clinically Significant Changes in Electrocardiograms | From first administration of study intervention through the end of study participation, around Day 36 | Electrocardiograms are tests that measure the electrical activity of the heart. Determination of clinical significance is based on investigator discretion. |
| Secondary | Maximum Change From Baseline in Hemoglobin | From first administration of study intervention through the end of study participation, around Day 36 | Maximum observed change from baseline in hemoglobin concentration. |
| Secondary | Maximum Change From Baseline in Hematocrit | From first administration of study intervention through the end of study participation, around Day 36 | Maximum observed change from baseline in hematocrit. |
| Secondary | Maximum Change from Baseline in Serum Iron | Baseline through the end of the treatment period, around Day 29 | |
| Secondary | Maximum Change from Baseline in Ferritin | Baseline through the end of the treatment period, around Day 29 | |
| Secondary | Maximum Change from Baseline in Transferrin Saturation | Baseline through the end of the treatment period, around Day 29 | |
| Secondary | Maximum Change from Baseline in Transferrin | Baseline through the end of the treatment period, around Day 29. | |
| Secondary | Maximum Change from Baseline in Reticulocyte Count | From first administration of study intervention through the end of study participation, around Day 36. | |
| Secondary | Maximum Change from Baseline in Red Blood Cell (RBC) Count | From first administration of study intervention through the end of study participation, around Day 36 | |
| Secondary | Maximum Change from Baseline in Mean Corpuscular Hemoglobin | From first administration of study intervention through the end of study participation, around Day 36 | |
| Secondary | Maximum Change From Baseline in Reticulocyte Hemoglobin Content | From first administration of study intervention through the end of study participation, around Day 36 | |
| Secondary | Plasma Concentrations of CTX001 | Pre-dose through the end of the pharmacokinetic sampling period. Days 1, 15, and 29; pre-dose and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post-dose. | Plasma concentrations of CTX001 by dose level over time. |
| Secondary | Maximum Observed Plasma Concentration of CTX001 (Cmax) | Pre-dose through the end of the pharmacokinetic sampling period. Days 1, 15, and 29; pre-dose and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post-dose. | The highest observed plasma concentration of CTX001 following dosing. |
| Secondary | Time to Maximum Observed Plasma Concentration of CTX001 (Tmax) | Pre-dose through the end of the pharmacokinetic sampling period. Days 1, 15, and 29; pre-dose and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post-dose. | Time from dosing to the maximum observed plasma concentration of CTX001. |
| Secondary | Area Under the Plasma Concentration-Time Curve of CTX001 From Time 0 to the Last Quantifiable Concentration (AUC0-t) | Pre-dose through the end of the pharmacokinetic sampling period. Days 1, 15, and 29; pre-dose and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post-dose. | Area under the CTX001 plasma concentration-time curve from dosing to the time of the last quantifiable concentration. |
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/NCT07901933/registered