Trial · NCT04585789
Registered outcomes41
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 41
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | Absolute change from baseline to on-treatment liver biopsy timepoint (Week 40) in terms of the percentage of HBsAg-positive hepatocytes (at Week 40) were reported. |
| 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) | Liver concentrations of JNJ-73763989 (JNJ-73763976, JNJ-73763924 - Molecules of JNJ-73763989 and JNJ-87719164 \[M65; deaminated metabolite of JNJ-73763976\]) at Week 12 were reported. |
| 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) | Liver concentrations of JNJ-73763989 (JNJ-73763976, and JNJ-73763924 and JNJ-87719164 \[M65; deaminated metabolite of JNJ-73763976\]) at Week 40 were reported. |
| 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) | Plasma concentration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924-molecules of JNJ-73763989) at Week 12 were reported. |
| 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) | Plasma concentrations of JNJ-73763989 (JNJ-73763976 and JNJ-73763924-molecules of JNJ-73763989) at Week 40 were reported. |
| 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) | 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 were reported. |
| 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) | 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 40 were reported. |
| 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 | Percentage of participants with sustained (reduction) serum HBsAg response per Definition 2 at follow-up Week 48 were reported. Sustained serum HBsAg response per definition 2 was defined as: for participants with a \>1 log decline in HBsAg from baseline at last follow up visit: Among the most recent three visits, the difference between log HBsAg at 2 of 3 last visit and 1 of 3 last visit is \<0.2, and the difference between log HBsAg at 3 of 3 last visit and 1 of 3 last visit is \<0.2. |
| Secondary | Panel 1, 2 and 3: Percentage of Participants Who Achieved HBsAg Seroclearance | Follow-up Week 48 | Percentage of Participants who achieved HBsAg Seroclearance were reported. HBsAg seroclearance was defined as quantitative HBsAg \<LLOQ (\<0.05 IU/mL). |
| Secondary | Panel 1, 2 and 3: Percentage of Participants Who Achieved HBeAg Seroclearance | Follow-up Week 48 | Percentage of Participants who achieved HBeAg Seroclearance were reported. HBeAg seroclearance was defined as (quantitative\] HBeAg \<LLOQ (\<0.11 IU/mL); with HBeAg positive status at baseline and became HBeAg negative post-baseline. |
| 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 | Change from baseline in percentage of intrahepatic viral parameter: HBcAg positive hepatocytes at Week 40 were reported. The percentage of HBcAg positive hepatocytes were derived as number of HBcAg positive hepatocytes\*100 per total number of evaluated hepatocytes. |
| 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 | Change from baseline in percentage of intrahepatic viral parameter: cccDNA positive hepatocytes were reported. The percentage of cccDNA-positive hepatocytes, were derived as number of cccDNA positive hepatocytes\*100 per total number of evaluated hepatocytes. |
| Secondary | Panel 1 and 2: Change From Baseline in Percentage of Intrahepatic Viral Parameter: HBsAg Positive (HBsAg+) Hepatocytes at Week 40 | Baseline, Week 40 | Change from baseline in percentage of intrahepatic viral parameter: HBsAg positive hepatocytes at Week 40 were reported. The percentage of HBsAg positive hepatocytes were derived as number of HBsAg positive hepatocytes \* 100 per total number of evaluated hepatocytes. |
| 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 | Change from baseline in percentage of intrahepatic viral Parameter: pgRNA positive hepatocytes at Week 40 were reported. The percentage of pgRNA-positive hepatocytes, were derived as number of pgRNA positive hepatocytes\*100 per total number of evaluated hepatocytes. |
| Secondary | Panel 1 and 2: Change From Baseline in Transcriptional Activity (Ratio of pg RNA/cccDNA) at Week 40 | Baseline, Week 40 | Change from baseline in transcriptional activity (ratio of pgRNA/cccDNA) at Week 40 were reported. |
| Secondary | Panel 1, 2: Change From Baseline in Percentage of Intrahepatic Viral Parameter: Silent Infected Hepatocytes at Week 40 | Baseline, Week 40 | Change from baseline in percentage of intrahepatic viral parameter: silent infected hepatocytes (that is infected hepatocytes without HBV transcription; cccDNA-positive/HBV RNA-negative hepatocytes) at Week 40 were reported. The percentage of silent infected hepatocytes (SIH), were derived as number of silent infected hepatocytes\*100 per total number of evaluated hepatocytes. |
| 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) | Percentage of participants with HBsAg seroclearance (defined as HBsAg \< LLOQ: 0.05 IU/mL) at Week 72 without restarting NA treatment were reported. |
| 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 | Percentage of participants with sustained (reduction) serum HBsAg response per Definition 1 at follow-up Week 48 were reported. Sustained serum HBsAg response per definition 1 was defined as: for participants with data for last follow-up visit (Follow-up Week 48 for participants who did not receive PegIFN-alpha2a or received PegIFN-alpha2a and did not meet NA completion criteria, and last Follow-up visit for participants who received PegIFN-alpha2a and stopped NA during Follow-up): participants who had a \>1 log decline in HBsAg response at last scheduled follow-up visit and had an HBsAg \<1000 IU/mL at last scheduled follow-up visit, or for participants without data at last follow-up visit: HBsAg values had a \>2 log decline at second most recent visit or \>1.5 log decline at latest visit (most recent value used) compared to baseline and had an HBsAg \<1000 IU/mL at last available timepoint. |
| 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 | Percentage of participants with sustained (reduction) serum HBsAg response per Definition 3 at follow-up Week 48 were reported. Sustained serum HBsAg response per definition 3 for participants with a \>1 log decline in HBsAg from baseline at last follow up visit: Among the most recent three visits, the difference between log HBsAg at 2 of 3 last visit and 1 of 3 last visit is \<0.2, and the difference between log HBsAg at 3 of 3 last visit and 1 of 3 last visit is \<0.2 and have an HBsAg \<1000 IU/mL at the last available timepoint. |
| 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 | Percentage of participants with sustained (reduction) serum HBsAg response per definition 4 follow-up Week 48 were reported. Sustained serum HBsAg response per definition 4 were classified into 3 categories with respect to the difference between HBsAg level at the last Follow-up timepoint and end of treatment: Increase: \>+0.2 log10 IU/mL , stable: within plus or minus (+/-) 0.2 log10 IU/mL, and decrease: \>-0.2 log10 IU/mL. |
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.
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