Trial · NCT04906980
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Log10-Transformed Dengue Virus (DENV) RiboNucleic Acid (RNA) Viral Load (VL) Curve From Baseline Until Day 5 (AUCD1-D5 [log10VL]). | Baseline (Day 1) upto Day 5 | The antiviral activity of JNJ-64281802 versus placebo in terms of reduction of DENV RNA in participants with a primary DENV infection was planned to be measured by the area under the log10-transformed DENV RNA viral load concentration-time curves from baseline (Day 1) until Day 5 (AUCD1-D5 \[log10VL\]). |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From Day 1 up to the last onsite visit (Day 30) | An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were those AE events that occurred at or after the initial administration of study intervention through the last onsite visit. |
| Secondary | Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings | From Day 1 up to the last onsite visit (Day 30) | Number of participants with clinically significant abnormalities in ECGs parameters as assessed based on investigator's discretion were reported. |
| Secondary | Number of Participants With Clinically Significant Abnormalities in Physical Examination | From Day 1 up to the last onsite visit (Day 30) | Number of participants with clinically significant abnormalities in physical examination parameters (head/neck/thyroid, eyes/ears/nose/throat, respiratory, cardiovascular, lymph nodes, abdomen, skin, musculoskeletal, and neurological) as assessed based on investigator's discretion were reported. |
| Secondary | Number of Participants With Clinically Significant Abnormalities in Vital Signs | From Day 1 up to the last onsite visit (Day 30) | Number of participants with clinically significant abnormalities in vital signs (temperature, pulse/heart rate, respiratory rate, peripheral capillary oxygen saturation \[spO2\], input-output \[I/O\] ratio and blood pressure) as assessed based on investigator's discretion were reported. |
| Secondary | Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | From Day 1 up to the last onsite visit (Day 30) | Number of participants with clinically significant abnormalities in laboratory parameters (serum chemistry, hematology, and coagulation) were reported. Clinical significance was defined as per investigator's judgement. |
| Secondary | Plasma Concentrations of JNJ-64281802 | Predose: 0, 8, 16 hours on Day 1; 24, 32, 40 hours on Day 2; Day 4, Day 5; and Post dose: 4, 12 hours on Day 1; 28, 36 hours on Day 2; 48 hours on Day 3; Day 6, Day 14, Day 21, Day 28 | Plasma Concentrations of JNJ-64281802 was assessed. Due to small number of enrolled participants, no summary statistics analysis was performed. Participant wise data were reported for this outcome measure. |
| Secondary | Number of Participants With Occurrence of Detectable Dengue Virus (DENV) RiboNucleic Acid (RNA) in Primary DENV Infection | Predose: 24 hour on Day 2; Post dose: 12 hour on Day 1; 36 hour on Day 2; Days 3, 4, 5, 6, 7, 8, 9, 14, 21 and 28 | Number of participants with occurrence of detectable DENV RNA in primary DENV infection was a planned analysis. |
| Secondary | Time to Undetectable Dengue Virus (DENV) RiboNucleic Acid (RNA) in Primary DENV Infection | Predose: 24 hour on Day 2; Post dose: 12 hour on Day 1; 36 hour on Day 2; Days 3, 4, 5, 6, 7, 8, 9, 14, 21 and 28 | Time to undetectable DENV RNA in primary DENV infection was a planned analysis. |
| Secondary | Area Under the Plasma Concentration Time Curve During One Dosing Interval (AUC[Tau]) of JNJ-64281802 | 0, 8, 16 hours pre-dose on Day 1; 4 and 12 hours post-dose on Day 1 | AUC\[tau\] is defined as area under the plasma concentration time curve during one dosing interval of JNJ-64281802. |
| Secondary | Trough (Pre-dose) Analyte Concentration (Ctrough) of JNJ-64281802 | Pre-dose on Day 1: 0 hour, 8 hour, 16 hour; pre-dose on Day 2: 24 hour, 32 hour, 40 hour; pre-dose on Day 4 and Day 5 | Ctrough is defined as plasma concentration just prior to the beginning or at the end of a dosing interval of JNJ-64281802. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of JNJ-64281802 | 0, 8, 16 hours pre-dose on Day 1; 4 and 12 hours post-dose on Day 1 | Cmax is defined as the maximum observed plasma concentration of JNJ-64281802. |
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/NCT04906980/registered