Trial · NCT04906980
A Study of JNJ-64281802 in Participants With Confirmed Dengue Fever
NCT04906980, Phase 2, Terminated, Janssen Research & Development, LLC; results first posted 2024-03-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of JNJ-64281802 in Participants With Confirmed Dengue Fever. Trials, record NCT04906980. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04906980
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of JNJ-64281802 in Participants With Confirmed Dengue Fever
- NCT number
- NCT04906980
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Dengue
- Interventions
- JNJ-64281802, Placebo
- First posted
- 2021-05-28
- Last updated
- 2024-03-01
- Results first posted
- 2024-03-01
- Limitations and caveats
Since feasibility of enrollment was impacted by COVID, sponsor terminated the study. Due to small number of enrolled participants, planned data collection and analysis was not performed for the efficacy objectives and thus no data was reported for efficacy outcome measures.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | Due to the small number of enrolled participants, planned data collection and analysis was not performed and thus no data was reported for this outcome measure. | ||
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From Day 1 up to the last onsite visit (Day 30) | Safety population included all randomized participants who had taken at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings | From Day 1 up to the last onsite visit (Day 30) | Safety population included all randomized participants who had taken at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Abnormalities in Physical Examination | From Day 1 up to the last onsite visit (Day 30) | Safety population included all randomized participants who had taken at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Abnormalities in Vital Signs | From Day 1 up to the last onsite visit (Day 30) | Safety population included all randomized participants who had taken at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | From Day 1 up to the last onsite visit (Day 30) | Safety population included all randomized participants who had taken at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | Pharmacokinetic population which included all participants who receive at least 1 dose of study drug and who had at least 1 plasma concentration data value after dosing. Data for this outcome measure was not planned to be collected and analyzed for the placebo arm. | nanograms per milliliter | NUMBER |
| 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 | Due to small number of enrolled participants, planned data collection and analysis was not performed and thus no data was reported for this outcome measure. | ||
| 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 | Due to small number of enrolled participants, planned data collection and analysis was not performed and thus no data was reported for this outcome measure. | ||
| 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 | Due to small number of enrolled participants, formal analysis was not performed for the planned PK parameters and thus no data was reported for this outcome measure |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | JNJ-64281802 | 2 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Placebo | 3 | Participants | ||
| Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings | JNJ-64281802 | 0 | Participants | ||
| Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings | Placebo | 0 | Participants | ||
| Number of Participants With Clinically Significant Abnormalities in Physical Examination | JNJ-64281802 | 0 | Participants | ||
| Number of Participants With Clinically Significant Abnormalities in Physical Examination | Placebo | 1 | Participants | ||
| Number of Participants With Clinically Significant Abnormalities in Vital Signs | JNJ-64281802 | 1 | Participants | ||
| Number of Participants With Clinically Significant Abnormalities in Vital Signs | Placebo | 0 | Participants | ||
| Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | JNJ-64281802 | 2 | Participants | ||
| Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Placebo | 3 | Participants |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | JNJ-64281802 | 2 | |
| Overall Study | STARTED | Placebo | 3 | |
| Overall Study | COMPLETED | JNJ-64281802 | 2 | |
| Overall Study | COMPLETED | Placebo | 3 | |
| Overall Study | NOT COMPLETED | JNJ-64281802 | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events64
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | JNJ-64281802 | 1 | 2 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 0 | 3 | |
| other | Neutropenia | Blood and lymphatic system disorders | JNJ-64281802 | 0 | 2 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo | 1 | 3 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | JNJ-64281802 | 0 | 2 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo | 2 | 3 | |
| other | Abdominal Distension | Gastrointestinal disorders | JNJ-64281802 | 0 | 2 | |
| other | Abdominal Distension | Gastrointestinal disorders | Placebo | 2 | 3 | |
| other | Abdominal Pain | Gastrointestinal disorders | JNJ-64281802 | 0 | 2 | |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo | 1 | 3 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | JNJ-64281802 | 0 | 2 |
| Total, all-cause mortality | Placebo | 0 | 3 |
| Total, other adverse events | JNJ-64281802 | 2 | 2 |
| Total, other adverse events | Placebo | 3 | 3 |
| Total, serious adverse events | JNJ-64281802 | 0 | 2 |
| Total, serious adverse events | Placebo | 0 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| JNJ-64281802 vs Placebo: Number of Participants With Clinically Significant Abnormalities in Vital Signs | Trial comparisons |
| JNJ-64281802 vs Placebo: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings | Trial comparisons |
| JNJ-64281802 vs Placebo: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Trial comparisons |
| JNJ-64281802 vs Placebo: Number of Participants With Clinically Significant Abnormalities in Physical Examination | Trial comparisons |
| JNJ-64281802 vs Placebo: deaths from any cause | Trial comparisons |
| JNJ-64281802 vs Placebo: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Trial comparisons |
| JNJ-64281802 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT04906980/results?page=2