Comparison · NCT04667104-b88590f1
TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA vs TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA: Number of Participants With Clinically Significant Abnormalities in Physical Examination as a Measure of Safety and Tolerability
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA vs TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA: Number of Participants With Clinically Significant Abnormalities in Physical Examination as a Measure of Safety and Tolerability. Trial comparisons, record NCT04667104-b88590f1. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04667104-b88590f1
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0 | 0.00000000000000000694 | 0.0741 | wilson | |
| Risk in group 2 | 0 | 0.00000000000000000694 | 0.0741 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0741 | 0.0741 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA | Participants received a single dose of JNJ-73763989 (JNJ-3989) 200 milligrams (mg) as a subcutaneous injection (SC) every 4 weeks (Q4W) along with JNJ-56136379 (JNJ-6379) 250 mg tablet once daily (QD) and nucleos(t)ide analog (NA) treatment (either entecavir\[ETV\] 0.5 mg, tenofovir disoproxil fumarate\[TDF\] 245 mg, or tenofovir alafenamide\[TAF\] 25 mg) QD up to 12 weeks in TP 1. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after protocol amendment 3, received JNJ-3989 + PegIFN-alpha 2a + NA only. Participants were assessed for eligibility criteria for PegIFN-alpha 2a at Week 12. Participants who met the criteria entered TP 2. | 0 | 48 | OG000 |
| Group 2 | TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only. | 0 | 48 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Clinically Significant Abnormalities in Physical Examination as a Measure of Safety and Tolerability
- Description
- Number of participants with clinically significant abnormalities in physical examination were reported.
- Time frame
- Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24
- Population
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Data for this outcome measure was not planned to be collected and analyzed for Follow-Up Period as pre-specified in protocol.
Source ClinicalTrials.gov
Trial
- Title
- A Study of JNJ-73763989, JNJ-56136379, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection
- NCT number
- NCT04667104
- Phases
- PHASE2
- Conditions
- Hepatitis B, Chronic
- Interventions
- JNJ-73763989, Tenofovir disoproxil, Tenofovir alafenamide (TAF), Entecavir (ETV) monohydrate, PegIFN-alpha2a
- Lead sponsor
- Janssen Research & Development, LLC
- Results first posted
- 2024-07-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04667104?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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