Trial · NCT04585789
Outcomes41
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 41
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Panel 1 and 2: Absolute Change From Baseline in the Percentage of Hepatitis B Surface Antigen (HBsAg) Hepatocytes at Week 40 | Baseline, Week 40 | Intent-to-treat (ITT) population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for Panels 1 and 2 alone. | percentage of HBsAg hepatocytes | MEAN |
| PRIMARY | Panel 3: Liver Concentrations of JNJ-73763989 (JNJ-73763976, JNJ-73763924 and JNJ-87719164 [M65; Deaminated Metabolite of JNJ-73763976]) at Week 12 | At Week 12 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989) | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Data for this outcome measure was planned to be collected and analyzed for Panel 3 alone. | nanograms per gram (ng/g) | MEAN |
| PRIMARY | Panel 3: Liver Concentrations of JNJ-73763989 (JNJ-73763976, and JNJ-73763924 and JNJ-87719164 [M65; Deaminated Metabolite of JNJ-73763976]) at Week 40 | At Week 40 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989) | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for Panel 3 alone. | ng/g | MEAN |
| PRIMARY | Panel 3: Plasma Concentration of JNJ-73763989 (JNJ-73763976, and JNJ-73763924) at Week 12 | At Week 12 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989) | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Data for this outcome measure was planned to be collected and analyzed for Panel 3 alone. | nanograms per milliliters (ng/mL) | MEAN |
| PRIMARY | Panel 3: Plasma Concentrations of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) at Week 40 | At Week 40 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989) | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Data for this outcome measure (OM) was planned to be collected and analyzed for Panel 3 alone. | ng/mL | MEAN |
| PRIMARY | Panel 3: Correlation of Liver Concentration to Plasma Concentration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) and Liver Concentration of JNJ-87719164 (M65: Deaminated Metabolite of JNJ-73763976) to Liver Concentration JNJ-73763976 at Week 12 | Week 12 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989) | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Data for this outcome measure was planned to be collected and analyzed for Panel 3 alone. | ratio | MEAN |
| PRIMARY | Panel 3: Correlation of Liver to Plasma Concentration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) and Liver Concentration of JNJ-87719164 (M65: Deaminated Metabolite of JNJ-73763976) to Liver Concentration JNJ-73763976 at Week 40 | Week 40 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989) | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for Panel 3 alone. | ratio | MEAN |
| SECONDARY | Panel 1, 2 and 3: Percentage of Participants With Sustained (Reduction) Serum HBsAg Response Per Definition 2 at Follow-up Week 48 | Follow-up Week 48 | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this OM. | Percentage of participants | NUMBER |
| SECONDARY | Panel 1, 2 and 3: Percentage of Participants Who Achieved HBsAg Seroclearance | Follow-up Week 48 | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Panel 1, 2 and 3: Percentage of Participants Who Achieved HBeAg Seroclearance | Follow-up Week 48 | ITT population: participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. N(Number of participants analyzed) = number of participants evaluable for this outcome measure. Data was not collected for Panel 2 participants as they were HBeAg negative at enrollment and thus did not fulfill planned analysis criteria (HBeAg positive status). | percentage of participants | NUMBER |
| SECONDARY | Panel 1 and 2: Change From Baseline in Percentage of Intrahepatic Viral Parameter: Hepatitis B Core Antigen Positive (HBcAg+) Hepatocytes at Week 40 | Baseline, Week 40 | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this OM was not planned to be collected and analyzed for Panel 3. | percent change in HBcAg+ Hepatocytes | MEDIAN |
| SECONDARY | Panel 1,and 2: Change From Baseline in Percentage of Intrahepatic Viral Parameter: Covalently Closed Circular Deoxyribonucleic Acid Positive (cccDNA+) Hepatocytes at Week 40 | Baseline, Week 40 | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Panel 3. | percent change in cccDNA+ hepatocytes | MEDIAN |
| SECONDARY | Panel 1 and 2: Change From Baseline in Percentage of Intrahepatic Viral Parameter: HBsAg Positive (HBsAg+) Hepatocytes at Week 40 | Baseline, Week 40 | ITT population included participants who were randomly assigned or enrolled to an intervention arm andreceived at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Panel 3. | percent change in HBsAg+ hepatocytes | MEDIAN |
| SECONDARY | Panel 1 and 2: Change From Baseline in Percentage of Intrahepatic Viral Parameter: Pre-genomic Ribonucleic Acid Positive (pgRNA+) Hepatocytes at Week 40 | Baseline, Week 40 | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this OM was not planned to be collected and analyzed for Panel 3. | percent change in pgRNA+ hepatocytes | MEDIAN |
| SECONDARY | Panel 1 and 2: Change From Baseline in Transcriptional Activity (Ratio of pg RNA/cccDNA) at Week 40 | Baseline, Week 40 | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Panel 3. | ratio | MEDIAN |
| SECONDARY | Panel 1, 2: Change From Baseline in Percentage of Intrahepatic Viral Parameter: Silent Infected Hepatocytes at Week 40 | Baseline, Week 40 | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Panel 3. | percent change in SIH | MEDIAN |
| SECONDARY | Panel 1, 2 and 3: Percentage of Participants With HBsAg Seroclearance at Week 72 Without Restarting Nucleos(t)Ide Analog (NA) Treatment | At Week 72 (24 weeks after completion of all study drugs at Week 48) | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Panel 1, 2 and 3: Percentage of Participants With Sustained (Reduction) Serum HBsAg Response Per Definition 1 at Follow-up Week 48 | Follow-up Week 48 | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. | Percentage of participants | NUMBER |
| SECONDARY | Panel 1, 2 and 3: Percentage of Participants With Sustained (Reduction) Serum HBsAg Response Per Definition 3 at Follow-up Week 48 | From follow-up Week 24 up to follow-up Week 48 | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Panel 1, 2 and 3: Percentage of Participants With Sustained (Reduction) Serum HBsAg Response Per Definition 4 at Follow-up Week 48 | Follow-up Week 48 | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. | Percentage of participants | NUMBER |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04585789/outcomes