Trial · NCT04535544
A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus
NCT04535544, Phase 2, Completed, Janssen Research & Development, LLC; results first posted 2024-11-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus. Trials, record NCT04535544. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04535544
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus
- NCT number
- NCT04535544
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 52 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Hepatitis D, Chronic
- Interventions
- JNJ-73763989, Placebo, Entecavir (ETV) monohydrate, Tenofovir disoproxil, Tenofovir alafenamide (TAF)
- First posted
- 2020-09-02
- Last updated
- 2026-07-22
- Other registries' IDs
- eudract:2020-001249-37
- Results first posted
- 2024-11-06
Source ClinicalTrials.gov
Registered outcomes69
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Double-blind:Part 1: Percentage of Participants With HDV Ribonucleic Acid (RNA) >=2 log10 IU/mL Decline From Baseline or HDV RNA Target Not Detected (TND) in Combination With Normal Alanine Aminotransferase (ALT) at Week 48 (Multiple Imputation Approach) | Week 48 | Percentage of participants with hepatitis D virus (HDV) RNA greater than or equal to (\>=) 2 log10 international units per milliliter (IU/mL) decline from baseline or HDV RNA TND in combination with normal ALT at Week 48 using multiple imputation approach was reported. TND was defined as no traces of HBV RNA were detected/found. Normal ALT was defined as ALT less than (\<) upper limit of normal (ULN) with ULN = 34 units per liter (U/L) for female and 43 U/L for male. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data. |
| Primary | Double-blind: Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination With Normal ALT at Week 48 (Multiple Imputation Approach) | Week 48 | Percentage of participants with HDV RNA \>=2 log10 IU/mL decline from baseline or HDV RNA TND in combination with normal ALT at Week 48 using multiple imputation approach was reported. TND was defined as no traces of HBV RNA were detected/found. Normal ALT was defined as ALT \<ULN with ULN = 34 U/L for female and 43 U/L for male. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data. |
| Secondary | Parts 1 and 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA < Lower Limits of Quantification (LLOQ) at Week 48 | Week 48 | Percentage of participants with HDV RNA \>=2 log10 IU/mL decline from baseline or HDV RNA \< LLOQ at Week 48 was reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data. |
| Secondary | Parts 1 and 2: Percentage of Participants With Normal ALT at Week 48 | Week 48 | Percentage of participants with normal ALT at Week 48 was reported. Normal ALT is defined as ALT \<ULN with ULN = 34 U/L for female and 43 U/L for male. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data. |
| Secondary | Parts 1 and 2: Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance at Week 48 | Week 48 | Percentage of participants with HBsAg seroclearance at Week 48 was reported. HBsAg seroclearance was defined as HBsAg negativity (quantitative HBsAg level \<LLOQ) based on the assay used. |
| Secondary | Parts 1 and 2: Percentage of Participants With >=2 Kilopascal (kPa) Reduction From Baseline in Liver Stiffness Measurement (LSM) Assessed by Vibration-controlled Transient Elastography (VCTE) (FibroScan) at Week 48 | Week 48 | Percentage of participants with \>=2 kPa reduction from baseline in LSM assessed by VCTE (fibroscan) at Week 48 was reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. |
| Secondary | Part 1: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination With Normal ALT | Week 48, FU Week 24 | Percentage of participants with HDV RNA \>=2 log10 IU/mL decline from baseline or HDV RNA TND in combination with normal ALT was reported. TND was defined as no traces of HBV RNA were detected/found. Normal ALT is defined as ALT \<ULN with ULN = 34 U/L for female and 43 U/L for male. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data. |
| Secondary | Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination With Normal ALT | Week 48, FU Week 24 | Percentage of participants with HDV RNA \>=2 log10 IU/mL decline from baseline or HDV RNA TND in combination with normal ALT was reported. TND was defined as no traces of HBV RNA were detected/found. Normal ALT is defined as ALT \<ULN with ULN = 34 U/L for female and 43 U/L for male. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data. |
| Secondary | Part 1: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline in Combination With Normal ALT | Week 48 and FU Week 24 | Percentage of participants with HDV RNA \>=2 log10 IU/mL decline from baseline in combination with normal ALT was reported. Normal ALT is defined as ALT \<ULN with ULN = 34 U/L for female and 43 U/L for male. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. |
| Secondary | Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline in Combination With Normal ALT | Week 48 and FU Week 24 | Percentage of participants with HDV RNA \>=2 log10 IU/mL decline from baseline in combination with normal ALT was reported. Normal ALT is defined as ALT \<ULN with ULN = 34 U/L for female and 43 U/L for male. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 registered outcomesOutcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Double-blind: Part 1: Percentage of Participants With HDV Ribonucleic Acid (RNA) >=2 log10 IU/mL Decline From Baseline or HDV RNA Target Not Detected (TND) in Combination With Normal Alanine Aminotransferase (ALT) at Week 48 (Multiple Imputation Approach) | At Week 48 | Intent-to-Treat analysis set (ITT) included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. | Percentage of Participants | NUMBER |
| PRIMARY | Double-blind: Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination With ALT at Week 48 (Multiple Imputation Approach) | At Week 48 | ITT analysis set included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Double-blind: Part 1: Percentage of Participants With HDV Ribonucleic Acid (RNA) >=2 log10 IU/mL Decline From Baseline or HDV RNA Target Not Detected (TND) in Combination With Normal Alanine Aminotransferase (ALT) at Week 48 (Multiple Imputation Approach) | Part 1: JNJ-73763989 + Nucleos(t)Ide Analog (NA) | 23.5 | Percentage of Participants | ||
Double-blind: Part 1: Percentage of Participants With HDV Ribonucleic Acid (RNA) >=2 log10 IU/mL Decline From Baseline or HDV RNA Target Not Detected (TND) in Combination With Normal Alanine Aminotransferase (ALT) at Week 48 (Multiple Imputation Approach) | Part 1: Placebo + NA | 0.0 | Percentage of Participants | ||
| Double-blind: Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination With ALT at Week 48 (Multiple Imputation Approach) | Part 2: JNJ-73763989 + NA | 27.1 | Percentage of Participants | ||
| Double-blind: Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination With ALT at Week 48 (Multiple Imputation Approach) | Part 2: Placebo + NA | 0.0 | Percentage of Participants |
Source ClinicalTrials.gov
Participant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind (Day 1 up to Week 52) | STARTED | Part 1: JNJ-73763989 + Nucleos(t)Ide Analog (NA) | 17 | |
| Double-blind (Day 1 up to Week 52) | STARTED | Part 1: Placebo + NA | 5 | |
| Double-blind (Day 1 up to Week 52) | STARTED | Part 2: JNJ-73763989 + NA | 24 | |
| Double-blind (Day 1 up to Week 52) | STARTED | Part 2: Placebo + NA | 6 | |
| Double-blind (Day 1 up to Week 52) | COMPLETED | Part 1: JNJ-73763989 + Nucleos(t)Ide Analog (NA) | 16 | |
| Double-blind (Day 1 up to Week 52) | COMPLETED | Part 1: Placebo + NA | 5 | |
| Double-blind (Day 1 up to Week 52) | COMPLETED | Part 2: JNJ-73763989 + NA | 20 | |
| Double-blind (Day 1 up to Week 52) | COMPLETED | Part 2: Placebo + NA | 5 | |
| Double-blind (Day 1 up to Week 52) | NOT COMPLETED | Part 1: JNJ-73763989 + Nucleos(t)Ide Analog (NA) | 1 | |
| Double-blind (Day 1 up to Week 52) | NOT COMPLETED | Part 1: Placebo + NA | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events1,650
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 | DB: Part 1: JNJ-73763989 + NA | 1 | 17 | |
| other | Anaemia | Blood and lymphatic system disorders | DB: Part 1: Placebo + NA | 0 | 5 | |
| other | Anaemia | Blood and lymphatic system disorders | DB: Part 2: JNJ-73763989 + NA | 1 | 24 | |
| other | Anaemia | Blood and lymphatic system disorders | DB: Part 2: Placebo + NA | 0 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | OL: Part 1: JNJ-73763989 + NA | 0 | 5 | |
| other | Anaemia | Blood and lymphatic system disorders | OL: Part 1: Placebo + NA | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | OL: Part 2: JNJ-73763989 + NA | 0 | 14 | |
| other | Anaemia | Blood and lymphatic system disorders | OL: Part 2: Placebo + NA | 0 | 5 | |
| other | Anaemia | Blood and lymphatic system disorders | FU: Part 1: JNJ-73763989 + NA | 0 | 16 | |
| other | Anaemia | Blood and lymphatic system disorders | FU: Part 1: Placebo + NA | 0 | 3 |
1 to 10 of 1,650Source ClinicalTrials.gov
See all 1,650 adverse eventsAdverse event totals33
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DB: Part 1: JNJ-73763989 + NA | 0 | 17 |
| Total, all-cause mortality | DB: Part 1: Placebo + NA | 0 | 5 |
| Total, all-cause mortality | DB: Part 2: JNJ-73763989 + NA | 0 | 24 |
| Total, all-cause mortality | DB: Part 2: Placebo + NA | 0 | 6 |
| Total, all-cause mortality | OL: Part 1: JNJ-73763989 + NA | 0 | 5 |
| Total, all-cause mortality | OL: Part 1: Placebo + NA | 0 | 4 |
| Total, all-cause mortality | OL: Part 2: JNJ-73763989 + NA | 0 | 14 |
| Total, all-cause mortality | OL: Part 2: Placebo + NA | 0 | 5 |
| Total, all-cause mortality | FU: Part 1: JNJ-73763989 + NA | 0 | 16 |
| Total, all-cause mortality | FU: Part 1: Placebo + NA | 0 | 3 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse event totalsPapers0
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.
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