Trial · NCT05005507
A Study of JNJ-73763989, Pegylated Interferon Alpha-2a and Nucleos(t)Ide Analogs in Participants With Chronic Hepatitis B Virus Infection
NCT05005507, Phase 2, Terminated, Janssen Research & Development, LLC; results first posted 2024-03-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of JNJ-73763989, Pegylated Interferon Alpha-2a and Nucleos(t)Ide Analogs in Participants With Chronic Hepatitis B Virus Infection. Trials, record NCT05005507. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05005507
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of JNJ-73763989, Pegylated Interferon Alpha-2a and Nucleos(t)Ide Analogs in Participants With Chronic Hepatitis B Virus Infection
- NCT number
- NCT05005507
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Hepatitis B, Chronic
- Interventions
- JNJ-73763989, PegIFN-alpha-2a, Tenofovir disoproxil, TAF, ETV
- First posted
- 2021-08-13
- Last updated
- 2024-03-06
- Other registries' IDs
- eudract:2021-002450-81
- Results first posted
- 2024-03-06
- Limitations and caveats
Only 1 participant was enrolled in the study in Arm 1. Participants were also planned to be enrolled in Arms 2 and 3 but were not enrolled as the study terminated prematurely based on a strategic decision and not for safety reasons.
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a Reduction of at Least 2log10 International Units Per Milliliter (IU/mL) in Hepatitis B Surface Antigen (HBsAg) Levels From Baseline at Week 24 (End of Study Intervention [EOSI]) | Week 24 | Percentage of participants with a reduction of at least 2log10 IU/mL in HBsAg levels from baseline at Week 24 (EOSI) were planned to be reported. |
| Secondary | Percentage of Participants With Adverse Events (AEs) | Up to 1 month 26 days | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. |
| Secondary | Percentage of Participants With Serious Adverse Events (SAEs) | Up to 1 month 26 days | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. |
| Secondary | Percentage of Participants With Abnormalities in Clinical Laboratory Tests | Up to 1 month 26 days | Percentage of participants with abnormalities in clinical laboratory tests including hematology, blood coagulation, blood biochemistry, urinalysis, urine chemistry, renal biomarkers, were reported. |
| Secondary | Percentage of Participants With Abnormalities in 12-Lead Electrocardiograms (ECGs) | Up to 1 month 26 days | Percentage of participants with abnormalities in 12-Lead ECGs were reported. |
| Secondary | Percentage of Participants With Abnormalities in Vital Signs | Up to 1 month 26 days | Percentage of participants with abnormalities in vital signs were reported. |
| Secondary | Percentage of Participants With Abnormalities in Ophthalmologic Examination | Weeks 8 and 20 | Percentage of participants with abnormalities in ophthalmologic examination were planned to be reported. |
| Secondary | Percentage of Participants With Abnormalities in Physical Examination | Week 24 | Percentage of participants with abnormalities in physical examination were planned to be reported. |
| Secondary | Percentage of Participants Meeting the Protocol-defined Nucleos(t)Ide Analog (NA) Treatment Completion Criteria Based on the Week 24 (EOSI) or Follow-up Week 2 Visits | Week 24 (EOSI) and follow-up Week 2 | Percentage of participants meeting the protocol-defined NA treatment completion criteria based on the Week 24 (EOSI) or follow-up Week 2 visits was planned to be reported. NA treatment completion criteria were as follows: (a) participant had alanine transaminase (ALT) \<3\*upper limits of normal (ULN); (b) participant had Hepatitis B Virus (HBV) Deoxyribonucleic acid (DNA) \<20 international units per milliliter (IU/mL); (c) participant was Hepatitis B e antigen (HBeAg)-negative; (d) participant had Hepatitis B surface antigen (HBsAg\<10 IU/mL. |
| Secondary | Percentage of Participants With HBsAg Seroclearance at Follow-up Weeks 24 and 48 Without Re-starting NA Treatment | Follow-up Weeks 24 and 48 | Percentage of participants with HBsAg seroclearance at follow-up Weeks 24 and 48 without re-starting NA treatment were planned to be reported. Seroclearance of HBsAg is defined as a (quantitative) HBsAg level \<lower limit of quantitation (LLOQ). LLOQ is 0.05 International Units per milliliter (IU/mL). |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With a Reduction of at Least 2log10 International Units Per Milliliter (IU/mL) in Hepatitis B Surface Antigen (HBsAg) Levels From Baseline at Week 24 (End of Study Intervention [EOSI]) | Week 24 | Full analysis set (FAS) included all participants who were randomly assigned to an intervention arm in the intervention-specific appendix (ISA) and received at least 1 dose of study intervention. The data was not collected and analyzed for this outcome measure due to premature termination of the study. | ||
| SECONDARY | Percentage of Participants With Adverse Events (AEs) | Up to 1 month 26 days | Safety analysis set included all participants who received at least 1 dose of study intervention within the ISA. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Serious Adverse Events (SAEs) | Up to 1 month 26 days | Safety analysis set included all participants who received at least 1 dose of study intervention within the ISA. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Abnormalities in Clinical Laboratory Tests | Up to 1 month 26 days | Safety analysis set included all participants who received at least 1 dose of study intervention within the ISA. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Abnormalities in 12-Lead Electrocardiograms (ECGs) | Up to 1 month 26 days | Safety analysis set included all participants who received at least 1 dose of study intervention within the ISA. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Abnormalities in Vital Signs | Up to 1 month 26 days | Safety analysis set included all participants who received at least 1 dose of study intervention within the ISA. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Abnormalities in Ophthalmologic Examination | Weeks 8 and 20 | Safety analysis set included all participants who received at least 1 dose of study intervention within the ISA. The data was not collected and analyzed for this outcome measure due to premature termination of the study. | ||
| SECONDARY | Percentage of Participants With Abnormalities in Physical Examination | Week 24 | Safety analysis set included all participants who received at least 1 dose of study intervention within the ISA. The data was not collected and analyzed for this outcome measure due to premature termination of the study. | ||
| SECONDARY | Percentage of Participants Meeting the Protocol-defined Nucleos(t)Ide Analog (NA) Treatment Completion Criteria Based on the Week 24 (EOSI) or Follow-up Week 2 Visits | Week 24 (EOSI) and follow-up Week 2 | FAS included all participants who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. The data was not collected and analyzed for this outcome measure due to premature termination of the study. | ||
| SECONDARY | Percentage of Participants With HBsAg Seroclearance at Follow-up Weeks 24 and 48 Without Re-starting NA Treatment | Follow-up Weeks 24 and 48 | FAS included all participants who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. The data was not collected and analyzed for this outcome measure due to premature termination of the study. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | Arm 1: JNJ-73763989+Nucleos(t)Ide Analog (NA)+PegIFN-alpha-2a | 0 | Percentage of participants | ||
| Percentage of Participants With Serious Adverse Events (SAEs) | Arm 1: JNJ-73763989+Nucleos(t)Ide Analog (NA)+PegIFN-alpha-2a | 0 | Percentage of participants | ||
| Percentage of Participants With Abnormalities in Clinical Laboratory Tests | Arm 1: JNJ-73763989+Nucleos(t)Ide Analog (NA)+PegIFN-alpha-2a | Hematology | 0 | Percentage of participants | |
| Percentage of Participants With Abnormalities in Clinical Laboratory Tests | Arm 1: JNJ-73763989+Nucleos(t)Ide Analog (NA)+PegIFN-alpha-2a | Blood coagulation | 0 | Percentage of participants | |
| Percentage of Participants With Abnormalities in Clinical Laboratory Tests | Arm 1: JNJ-73763989+Nucleos(t)Ide Analog (NA)+PegIFN-alpha-2a | Blood biochemistry | 0 | Percentage of participants | |
| Percentage of Participants With Abnormalities in Clinical Laboratory Tests | Arm 1: JNJ-73763989+Nucleos(t)Ide Analog (NA)+PegIFN-alpha-2a | Urinalysis | 0 | Percentage of participants | |
| Percentage of Participants With Abnormalities in Clinical Laboratory Tests | Arm 1: JNJ-73763989+Nucleos(t)Ide Analog (NA)+PegIFN-alpha-2a | Urine chemistry | 0 | Percentage of participants | |
| Percentage of Participants With Abnormalities in Clinical Laboratory Tests | Arm 1: JNJ-73763989+Nucleos(t)Ide Analog (NA)+PegIFN-alpha-2a | Renal biomarker | 0 | Percentage of participants | |
| Percentage of Participants With Abnormalities in 12-Lead Electrocardiograms (ECGs) | Arm 1: JNJ-73763989+Nucleos(t)Ide Analog (NA)+PegIFN-alpha-2a | 0 | Percentage of participants | ||
| Percentage of Participants With Abnormalities in Vital Signs | Arm 1: JNJ-73763989+Nucleos(t)Ide Analog (NA)+PegIFN-alpha-2a | 0 | Percentage of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1: JNJ-73763989+Nucleos(t)Ide Analog (NA)+PegIFN-alpha-2a | 1 | |
| Overall Study | COMPLETED | Arm 1: JNJ-73763989+Nucleos(t)Ide Analog (NA)+PegIFN-alpha-2a | 0 | |
| Overall Study | NOT COMPLETED | Arm 1: JNJ-73763989+Nucleos(t)Ide Analog (NA)+PegIFN-alpha-2a | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1: JNJ-73763989+Nucleos(t)Ide Analog (NA)+PegIFN-alpha-2a | 0 | 1 |
| Total, other adverse events | Arm 1: JNJ-73763989+Nucleos(t)Ide Analog (NA)+PegIFN-alpha-2a | 0 | 1 |
| Total, serious adverse events | Arm 1: JNJ-73763989+Nucleos(t)Ide Analog (NA)+PegIFN-alpha-2a | 0 | 1 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
GET https://conductscience.org/api/trials/v1/NCT05005507
GET https://conductscience.org/api/trials/v1/NCT05005507/registered?page=2