Trial · NCT07419373
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 36
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Treatment-Emergent Adverse Events (TEAEs) Grade ≥3 | Day 1 through Day 28 | Type and frequency of treatment-emergent adverse events of Grade 3 or higher |
| Primary | Change in Viral Load Slope (RT-PCR Ct Values) | Day 1 to Day 10 | Change in slope of Lassa virus RT-PCR cycle threshold (Ct) values between Day 1 and Day 10 in participants with low baseline Ct values. |
| Secondary | Change in Viral Load Slope in Participants with Other Baseline Ct Values | Day 1 to Day 10 | Change in slope for LASV RT-PCR Ct values between Day 1 and Day 10, for subjects with other baseline Ct values (to be determined \[TBD\], subsequent to RT-PCR methods validation). |
| Secondary | Change in RT-PCR Ct Values at Prespecified Timepoints (Change in Ct values. between Day 1 and Days 2, 3, 4, 6, 8, and 10). | Day 1 to Day 10 | Change in Ct values between Day 1 and each of Days 2, 3, 4, 6, 8, and 10 for the ARN-75039 arms vs SOC for those with baseline Ct \<30 (or other Ct values TBD). |
| Secondary | Time to First RT-PCR Result Below Lower Limit of Quantification (LLOQ) | Day 1 to Day 28 | Time to reach lower limit of quantification \[LLOQ\] and undetectable Ct values. |
| Secondary | Time to First Undetectable Lassa Virus RT-PCR Result | Day 1 to Day 28 | Time to reach undetectable Ct values. |
| Secondary | Proportion of Participants With RT-PCR <LLOQ | Day 1 to Day 28 | LASV RT-PCR \<LLOQ (% of participants) for specified baseline Ct values (TBD). |
| Secondary | Proportion of Participants With Undetectable RT-PCR | Day 1 to Day 28 | LASV RT-PCR undetectable (% of participants) for specified baseline Ct values TBD. |
| Secondary | Estimated Baseline Lassa Virus RT-PCR Cycle Threshold (Ct) Value (Intercept) from Linear Mixed-Effects Model | Day 1 | Estimated baseline Lassa virus RT-PCR cycle threshold (Ct) value derived from a linear mixed-effects model of longitudinal Ct measurements collected between Day 1 and Day 10. Results will be reported as model-estimated mean Ct value (Ct units). |
| Secondary | Estimated Rate of Change in Lassa Virus RT-PCR Ct Value (Ct Units per Day) from Linear Mixed-Effects Model. | Day 1 to Day 10 | Estimated rate of change (slope) in Lassa virus RT-PCR cycle threshold (Ct) values over time, calculated using a linear mixed-effects model of longitudinal Ct measurements from Day 1 through Day 10. Results will be reported as mean change in Ct units per day (Ct/day). |
| Secondary | Change in Ct values stratified by Lassa lineage (Ct <30) | Day 1 to Day 10 | Change in Ct values stratified by Lassa lineage for subjects with baseline Ct \<30 or other baseline Ct values TBD. |
| Secondary | Pharmacokinetic Outcome: ARN-75039 AUC₀-t | Day 1 through Day 10 | Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration. |
| Secondary | Pharmacokinetic Outcome: ARN-75039 AUC₀-∞ | Day 1 through Day 10 | Area under plasma concentration-time curve from time 0 to infinity. |
| Secondary | Pharmacokinetic Outcome: ARN-75039 Cmax | Day 1 through Day 10 | Maximum observed plasma concentration. |
| Secondary | Pharmacokinetic Outcome: ARN-75039 Ctrough (Cmin0-24hr) | Day 1 through Day 10 | Trough concentration (Ctrough) exposures: Cmin(0-24hr) exposures taken prior to first dose on Days 2, 4, and 10. |
| Secondary | Pharmacokinetic Outcome: ARN-75039 Tmax | Day 1 through Day 10 | Time to reach Cmax |
| Secondary | Pharmacokinetic Outcome: t½ | Day 1 through Day 10 | ARN-75039 half-life |
| Secondary | Pharmacokinetic Outcome: ARN-75039 apparent clearance (CL/F) | Day 1 through Day 10 | Apparent Clearance |
| Secondary | Pharmacokinetic Outcome: ARN-75039 apparent volume of distribution (Vz/F) | Day 1 through Day 10 | Apparent volume of distribution during the terminal phase. |
| Secondary | Association Between ARN-75039 Plasma Exposure (AUC₀-t) and Change in Lassa Virus RT-PCR Ct Value. | Day 1 to Day 10 | The association between individual plasma exposure to ARN-75039, measured as area under the concentration-time curve from time 0 to time of last quantifiable concentration (AUC₀-t), and change in Lassa virus RT-PCR cycle threshold (Ct) values from Day 1 to Day 10 will be evaluated using linear regression modeling. Results will be reported as regression slope (change in Ct per unit increase in AUC) with corresponding 95% confidence intervals. |
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/NCT07419373/registered