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- | daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Phase classification: A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - Jul 31, 2024
P2, N=130, Completed, Sponsor: Janssen Sciences Ireland UC
Phase classification: P2b --> P2
- | daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Phase classification: REEF-1: A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - Jul 9, 2024
P2, N=471, Completed, Sponsor: Janssen Sciences Ireland UC
Phase classification: P2b --> P2 Phase classification: P2b --> P2
- daplusiran/tomligisiran (GSK5637608) / GSK
Intrahepatic changes in immunologic and virologic markers during siRNA JNJ-73763989 (JNJ-3989) based treatment of chronic hepatitis B (CHB) patients: imaging mass cytometry (IMC) analyses from the INSIGHT study (Poster Area) - Apr 2, 2024 - Abstract #EASLILC2024EASL_ILC_860;
Phase classification: P2b --> P2 In INSIGHT, CHB patients who were hepatitis B e-antigen (HBeAg) positive and not currently treated (Group 1) or HBeAg
- ||| daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Trial completion: A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection (clinicaltrials.gov) - Mar 27, 2024
P2, N=54, Completed, Sponsor: Janssen Research & Development, LLC
In INSIGHT, CHB patients who were hepatitis B e-antigen (HBeAg) positive and not currently treated (Group 1) or HBeAg Active, not recruiting --> Completed
- || daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Biomarker, Trial completion: INSIGHT: A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - Mar 5, 2024
P2, N=24, Completed, Sponsor: Janssen Research & Development, LLC
Active, not recruiting --> Completed Active, not recruiting --> Completed
- JNJ-3989 / J&J
INTRAHEPATIC CHANGES IN VIRAL AND IMMUNE MARKERS FOLLOWING TREATMENT WITH JNJ-73763989 (JNJ-3989) AND NUCLEOS(T)IDE ANALOGS (NAS), IN PATIENTS WITH CHRONIC HEPATITIS B (CHB): INSIGHT WEEK 40 (W40) INTERIM RESULTS (Room 304/306) - Oct 11, 2023 - Abstract #AASLD2023AASLD_885;
Active, not recruiting --> Completed Background: Treatment of CHB with JNJ-3989 and NA
- | bersacapavir (JNJ-56136379) / J&J
Journal: Binding characteristics of pyrrole-scaffold hepatitis B virus capsid inhibitors and identification of novel potent compounds. (Pubmed Central) - Oct 9, 2023
This study used in silico computational modeling to provide insights into the binding characteristics between the HBV core protein and two pyrrole-scaffold inhibitors, JNJ-6379 and GLP-26, both in the CAM-Normal (CAM-N) series...Through analyses of the structure-activity and structure-druggability relations of a series of compounds, CU15 emerged as the most promising lead CAM-N compound, exhibiting sub-nanomolar potency and good pharmacokinetic profiles. Overall, the study demonstrated a practical approach to leverage computational methods for understanding key target binding features for rationale-based design, and for guiding the identification of novel compounds.
- | daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Biomarker, Trial primary completion date: INSIGHT: A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - Jul 22, 2023
P2, N=24, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Overall, the study demonstrated a practical approach to leverage computational methods for understanding key target binding features for rationale-based design, and for guiding the identification of novel compounds. Trial primary completion date: Jul 2023 --> Feb 2023
- || JNJ-3989 / J&J, bersacapavir (JNJ-56136379) / J&J
P2b data, Journal: Efficacy and safety of the siRNA JNJ-73763989 and the capsid assembly modulator JNJ-56136379 (bersacapavir) with nucleos(t)ide analogues for the treatment of chronic hepatitis B virus infection (REEF-1): a multicentre, double-blind, active-controlled, randomised, phase 2b trial. (Pubmed Central) - Jul 14, 2023
P2b
Although treatment with JNJ-3989 led to a dose-dependent response for meeting nucleos(t)ide analogue-stopping criteria, it rarely led to HBsAg seroclearance. However, most patients treated with JNJ-3989 had clinically meaningful reductions in HBsAg that might contribute to a liver environment conducive to better immune control and, in turn, might improve the response to immune-modulating therapies.
- || daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Trial primary completion date: A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection (clinicaltrials.gov) - May 31, 2023
P2, N=54, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
However, most patients treated with JNJ-3989 had clinically meaningful reductions in HBsAg that might contribute to a liver environment conducive to better immune control and, in turn, might improve the response to immune-modulating therapies. Trial primary completion date: Apr 2023 --> Sep 2023
- || daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Trial completion: PENGUIN: 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 (clinicaltrials.gov) - May 17, 2023
P2, N=48, Completed, Sponsor: Janssen Research & Development, LLC
Trial primary completion date: Apr 2023 --> Sep 2023 Active, not recruiting --> Completed
- JNJ-3989 / J&J, bersacapavir (JNJ-56136379) / J&J
Association of post-treatment virologic relapse and biochemical flares with HBV serum biomarkers in long-term virologically suppressed HBeAg-negative patients stopping NA treatment: Exploratory analyses from the control arm of the REEF-2 study (Poster Area) - Apr 12, 2023 - Abstract #EASLILC2023EASL_ILC_2049;
P2b
In patients discontinuing NA treatment, the level of HBV DNA increases during viral relapse correlated with the peak levels of biochemical flares. EOT anti-HBc IgG levels ?300 IU/mL were strongly associated with the absence of high peak HBV DNA virologic relapse and high peak ALT flares ?10
- JNJ-3989 / J&J, bersacapavir (JNJ-56136379) / J&J
Intrahepatic characterization of virological and immunological markers in two distinct populations of chronic hepatitis B: baseline assessment of core liver and fine needle aspiration biopsies from the investigational INSIGHT study (Poster Area) - Apr 12, 2023 - Abstract #EASLILC2023EASL_ILC_1681;
P2
EOT anti-HBc IgG levels ?300 IU/mL were strongly associated with the absence of high peak HBV DNA virologic relapse and high peak ALT flares ?10 Intrahepatic characterization of virological and immunological markers in two distinct populations of chronic hepatitis B: pre-treatment core liver and fine needle aspiration biopsies from the investigational INSIGHT study Background and Aims: Treatment of chronic hepatitis B (CHB) patients with the siRNA JNJ- 73763989 (JNJ-3989) and nucleos(t)ide analogs (NAs)
- || JNJ-3989 / J&J, bersacapavir (JNJ-56136379) / J&J
PK/PD data, Journal: Pharmacokinetics of Jnj-73763989 And Jnj-56136379 (Bersacapavir) In Participants With Moderate Hepatic Impairment. (Pubmed Central) - Feb 14, 2023
Overall, the plasma exposures of JNJ-73763989 and JNJ-56136379 were higher in participants with moderate hepatic impairment, but both were well tolerated. Further studies are needed to evaluate the effect of hepatic impairment under multiple dose administration.
- || bersacapavir (JNJ-56136379) / J&J
P2 data, Journal: Randomised phase 2 study (JADE) of the HBV capsid assembly modulator JNJ-56136379 with or without a nucleos(t)ide analogue in patients with chronic hepatitis B infection. (Pubmed Central) - Jan 26, 2023
P2a
Further studies are needed to evaluate the effect of hepatic impairment under multiple dose administration. In patients with non-cirrhotic CHB, JNJ-56136379+NA showed pronounced reductions in HBV DNA and HBV RNA, limited HBsAg or HBeAg declines in patients who are NCT HBeAg positive, and was well tolerated, but no clear benefit with regards to efficacy of JNJ-56136379 over NA was observed.
- | daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Trial primary completion date: PENGUIN: 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 (clinicaltrials.gov) - Nov 23, 2022
P2, N=48, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
In patients with non-cirrhotic CHB, JNJ-56136379+NA showed pronounced reductions in HBV DNA and HBV RNA, limited HBsAg or HBeAg declines in patients who are NCT HBeAg positive, and was well tolerated, but no clear benefit with regards to efficacy of JNJ-56136379 over NA was observed. Trial primary completion date: Oct 2022 --> May 2022
- JNJ-3989 / J&J, bersacapavir (JNJ-56136379) / J&J
EFFICACY AND SAFETY OF siRNA JNJ-73763989, CAPSID ASSEMBLY MODULATOR JNJ56136379, NUCLEOS(T)IDE ANALOG (NA), AND PEGYLATED INTERFERON ALPHA-2a (PEGIFNα2a) FOR TREATMENT OF CHRONIC HEPATITIS B (CHB): WEEK 24 RESULTS FROM THE PHASE 2 PENGUIN STUDY () - Nov 2, 2022 - Abstract #AASLD2022AASLD_2423;
P2
Addition of JNJ3989±JNJ-6379 and PegIFN-α2a to NA was generally safe and well tolerated in PENGUIN and resulted in profound HBsAg reduction and a high proportion of patients achieving HBsAg <100 IU/mL at W24. The additional antiviral effect of PegIFN-α2a in this regimen needs further evaluation.
- JNJ-3989 / J&J, bersacapavir (JNJ-56136379) / J&J
EFFICACY AND SAFETY OF COMBINATION TREATMENT WITH siRNA JNJ-73763989 AND CAPSID ASSEMBLY MODULATOR JNJ-56136379 (BERSACAPAVIR) IN HBEAG NEGATIVE VIROLOGICALLY SUPPRESSED CHRONIC HEPATITIS B PATIENTS: FOLLOW-UP WEEK 48 END OF STUDY RESULTS FROM REEF-2 (Ballroom ABC) - Nov 2, 2022 - Abstract #AASLD2022AASLD_2400;
P2b
Treatment with JNJ-3989 + JNJ-6379 + NA for 48 weeks was generally safe and well tolerated. After stopping all treatments, including NA, at W48, no patient achieved the primary endpoint, but lower HBsAg levels and greater HBV DNA suppression were observed for patients in the active arm after 48 weeks of FU.
- JNJ-3989 / J&J
VIRAL SEQUENCE ANALYSIS OF NOT-CURRENTLY TREATED (NCT) CHRONIC HEPATITIS B (CHB) PATIENTS ENROLLED IN THE REEF-1 STUDY AND IMPACT OF BASELINE NUCLEOTIDE POLYMORPHISMS IN THE SMALL INTERFERING RNA (siRNA) JNJ-3989 TRIGGER TARGET REGIONS ON VIRAL ANTIGEN DECLINES () - Oct 23, 2022 - Abstract #AASLD2022AASLD_709;
P2b
Treatment of CHB patients with Q4W s.c. injections of JNJ-3989 (40-200mg) ± once-daily oral 250mg JNJ-6379 (CAM-N) in combination with nucleos(t)ide analogues for 48 weeks in the REEF-1 study (NCT03982186) led to dose-dependent reductions in hepatitis B virus (HBV) markers. Baseline nt polymorphisms in the JNJ-3989 S- and X-trigger target region were present in~10% of NCT patients and had no apparent impact on JNJ-3989 induced viral antigen declines.
- | JNJ-3989 / J&J
Clinical Trial,Phase II, Journal: Combination treatments including the small-interfering RNA JNJ-3989 induce rapid and sometimes prolonged viral responses in patients with CHB. (Pubmed Central) - Oct 20, 2022
P1/2
Baseline nt polymorphisms in the JNJ-3989 S- and X-trigger target region were present in~10% of NCT patients and had no apparent impact on JNJ-3989 induced viral antigen declines. JNJ-3989 plus an NA, with/without JNJ-6379, was well tolerated and resulted in HBsAg reductions up to 336 days after the last JNJ-3989 Q4W dose.
- | bersacapavir (JNJ-56136379) / J&J
Journal: Drug-Drug Interactions With the Hepatitis B Virus Capsid Assembly Modulator JNJ-56136379 (Bersacapavir). (Pubmed Central) - Sep 7, 2022
P1
Overall, these results demonstrated that a strong CYP3A inhibitor (itraconazole) modestly increased JNJ-56136379 exposure. Furthermore, JNJ-56136379 was a weak inducer of CYP3A (midazolam) and increased ethinyl estradiol exposure; coadministration of high-dose estrogen-based contraceptives and JNJ-56136379 is not recommended.
- ||| daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Trial completion: A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - Jul 7, 2022
P2b, N=130, Completed, Sponsor: Janssen Sciences Ireland UC
Furthermore, JNJ-56136379 was a weak inducer of CYP3A (midazolam) and increased ethinyl estradiol exposure; coadministration of high-dose estrogen-based contraceptives and JNJ-56136379 is not recommended. Active, not recruiting --> Completed
- || JNJ-73763989 / J&J, bersacapavir (JNJ-56136379) / J&J
PK/PD data, Journal: JNJ-73763989 pharmacokinetics and safety: Liver-targeted siRNAs against hepatitis B virus, in Japanese and non-Japanese healthy adults, and combined with JNJ-56136379 and a nucleos(t)ide analogue in patients with chronic hepatitis B. (Pubmed Central) - Jun 14, 2022
P1, P1/2
JNJ-73763976 and JNJ-73763924 had short plasma half-lives and exposure generally increased in a dose-proportional manner; there were no pharmacokinetic differences between Japanese and non-Japanese healthy adults. JNJ-73763989 with or without JNJ-56136379 and NA was generally safe and well tolerated.
- JNJ-73763989 / J&J, bersacapavir (JNJ-56136379) / J&J
Efficacy and safety of finite 48-week treatment with the siRNA JNJ-3989 and the capsid assembly modulator (CAM-N) JNJ-6379 in HBeAg negative virologically suppressed (VS) chronic hepatitis B (CHB) patients: results from REEF-2 study (Auditorium) - Jun 11, 2022 - Abstract #EASLILC2022EASL_ILC_2526;
All treatment including NA was discontinued after 48 weeks. The primary endpoint was the proportion of patients achieving HBsAg
- |||| daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Trial completion, Trial completion date: REEF-1: A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - Jun 8, 2022
P2b, N=471, Completed, Sponsor: Janssen Sciences Ireland UC
The primary endpoint was the proportion of patients achieving HBsAg Active, not recruiting --> Completed | Trial completion date: Feb 2023 --> Apr 2022
- || daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Enrollment closed: A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection (clinicaltrials.gov) - Jun 8, 2022
P2, N=54, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Active, not recruiting --> Completed | Trial completion date: Feb 2023 --> Apr 2022 Recruiting --> Active, not recruiting
- JNJ-73763989 / J&J, bersacapavir (JNJ-56136379) / J&J
Effects of the siRNA JNJ-3989 and/or the capsid assembly modulator (CAM-N) JNJ-6379 on viral markers of chronic hepatitis B (CHB): results from the REEF-1 study (Poster Area) - May 12, 2022 - Abstract #EASLILC2022EASL_ILC_1932;
P2b
Treatment with JNJ-3989 reduced levels of HBV markers in a dose dependent manner. Reductions in viral markers were most pronounced in NCT HBeAg+ patients.
- | daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Biomarker, Enrollment closed: INSIGHT: A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - Apr 13, 2022
P2, N=24, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Reductions in viral markers were most pronounced in NCT HBeAg+ patients. Recruiting --> Active, not recruiting
- JNJ-73763989 / J&J, bersacapavir (JNJ-56136379) / J&J
Understanding the dynamics of HBsAg decline through model-informed drug development (MIDD) of JNJ-3989 and JNJ-6379 for the treatment of chronic hepatitis B virus infection (CHB) (Poster Area) - Mar 16, 2022 - Abstract #EASLILC2022EASL_ILC_1729;
HBsAg levels decreased in a dosedependent manner up to 48 weeks of JNJ-3989 treatment in REEF-1. Covariate analysis identified that HBsAg dynamics display treatmentand subgroup-specific behavior.
- | vebicorvir (ABI-H0731) / Assembly Biosci, morphothiadine mesilate (GLS4) / HEC Pharm, bersacapavir (JNJ-56136379) / J&J
Journal: An automated microfluidic platform for the screening and characterization of novel hepatitis B virus capsid assembly modulators. (Pubmed Central) - Mar 3, 2022
With this proof-of-concept study, we believe that this microfluidic system is a robust primary screening tool for HBV CAM drug discovery, especially for the hit finding and hit-to-lead optimization phases. In addition to EC values, this system gives valuable first information about the mode of action of novel CAM screening compounds.
- | daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Enrollment closed: PENGUIN: 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 (clinicaltrials.gov) - Jan 19, 2022
P2, N=48, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
In addition to EC values, this system gives valuable first information about the mode of action of novel CAM screening compounds. Recruiting --> Active, not recruiting
- | daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Trial completion date: A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection (clinicaltrials.gov) - Nov 23, 2021
P2, N=60, Recruiting, Sponsor: Janssen Research & Development, LLC
Recruiting --> Active, not recruiting Trial completion date: Nov 2023 --> Feb 2024
- | daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Trial completion date: A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection (clinicaltrials.gov) - Sep 1, 2021
P2, N=80, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial completion date: Nov 2023 --> Feb 2024 Trial completion date: Apr 2024 --> Nov 2023
- || JNJ-56136379 / J&J
Clinical, Journal, Monotherapy: Virology analysis of chronic hepatitis B infected patients treated for 28 days with JNJ-56136379 monotherapy. (Pubmed Central) - Aug 27, 2021
P1
In conclusion, baseline polymorphisms and enrichment of substitutions reducing JNJ-6379 in-vitro activity were rare, with no consistent impact on virological response during a 4 week phase 1b study. Emergence of resistance to longer treatments of JNJ-6379 will be evaluated in phase 2 studies.
- || daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Trial primary completion date: A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - Aug 18, 2021
P2b, N=130, Active, not recruiting, Sponsor: Janssen Sciences Ireland UC
Emergence of resistance to longer treatments of JNJ-6379 will be evaluated in phase 2 studies. Trial primary completion date: Jan 2022 --> Jul 2021
- | daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Trial completion date: PENGUIN: 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 (clinicaltrials.gov) - Aug 18, 2021
P2, N=50, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial primary completion date: Jan 2022 --> Jul 2021 Trial completion date: Jan 2023 --> May 2023
- | daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Biomarker, Trial completion date: INSIGHT: A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - Aug 18, 2021
P2, N=24, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial completion date: Jan 2023 --> May 2023 Trial completion date: Oct 2023 --> Jan 2024
- | daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Trial completion date: A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection (clinicaltrials.gov) - Aug 18, 2021
P2, N=80, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial completion date: Oct 2023 --> Jan 2024 Trial completion date: Dec 2023 --> Apr 2024
- bersacapavir (JNJ-56136379) / J&J
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: A Study to Evaluate the Effect of Renal Impairment on JNJ-56136379 in Adult Participants (clinicaltrials.gov) - Aug 18, 2021
P1, N=1, Terminated, Sponsor: Janssen Research & Development, LLC
Trial completion date: Dec 2023 --> Apr 2024 N=64 --> 1 | Trial completion date: Sep 2021 --> Nov 2020 | Recruiting --> Terminated | Trial primary completion date: Jul 2021 --> Nov 2020; Strategic Decision
- | bersacapavir (JNJ-56136379) / J&J
Enrollment change, Trial withdrawal: A Study of JNJ-56136379 in Healthy Participants (clinicaltrials.gov) - Jul 14, 2021
P1, N=0, Withdrawn, Sponsor: Janssen Research & Development, LLC
N=64 --> 1 | Trial completion date: Sep 2021 --> Nov 2020 | Recruiting --> Terminated | Trial primary completion date: Jul 2021 --> Nov 2020; Strategic Decision N=21 --> 0 | Recruiting --> Withdrawn
- | daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Biomarker, Trial completion date: INSIGHT: A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - Jul 7, 2021
P2, N=24, Recruiting, Sponsor: Janssen Research & Development, LLC
N=21 --> 0 | Recruiting --> Withdrawn Trial completion date: Jul 2023 --> Oct 2023
- | JNJ-56136379 / J&J
Preclinical, Journal: Anti-HBV activity of the HBV capsid assembly modulator JNJ-56136379 across full-length genotype A-H clinical isolates and core site-directed mutants in vitro. (Pubmed Central) - Jun 26, 2021
JNJ-56136379, a potent HBV CAM-N, currently in Phase 2 clinical development, was generally fully active against an extensive panel of genotype A-H clinical isolates, regardless of the presence of nucleos(t)ide analogue resistance or BCP/PC mutations. JNJ-56136379 activity was reduced by some core amino acid substitutions in the CAM-binding pocket.
- || bersacapavir (JNJ-56136379) / J&J
Enrollment open: A Study of JNJ-56136379 in Healthy Participants (clinicaltrials.gov) - May 20, 2021
P1, N=21, Recruiting, Sponsor: Janssen Research & Development, LLC
JNJ-56136379 activity was reduced by some core amino acid substitutions in the CAM-binding pocket. Not yet recruiting --> Recruiting
- ||| daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Enrollment change, Trial completion date: PENGUIN: 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 (clinicaltrials.gov) - Apr 22, 2021
P2, N=50, Recruiting, Sponsor: Janssen Research & Development, LLC
Not yet recruiting --> Recruiting N=20 --> 50 | Trial completion date: Oct 2022 --> Jan 2023
- || bersacapavir (JNJ-56136379) / J&J
New P1 trial: A Study of JNJ-56136379 in Healthy Participants (clinicaltrials.gov) - Apr 20, 2021
P1, N=21, Not yet recruiting, Sponsor: Janssen Research & Development, LLC
- || bersacapavir (JNJ-56136379) / J&J
Trial completion, Enrollment change: A Study to Evaluate the Effect of Hepatic Impairment on JNJ-56136379 (clinicaltrials.gov) - Apr 20, 2021
P1, N=16, Completed, Sponsor: Janssen Sciences Ireland UC
N=20 --> 50 | Trial completion date: Oct 2022 --> Jan 2023 Recruiting --> Completed | N=48 --> 16
- | JNJ-56136379 / J&J
Journal: Antiviral Properties and Mechanism of Action Studies of the Hepatitis B Virus Capsid Assembly Modulator JNJ-56136379. (Pubmed Central) - Apr 7, 2021
Collectively, these data demonstrate that JNJ-6379 has a dual MOA on the early and late steps of the HBV life cycle, which is different to the MOA of nucleos(t)ide analogues. JNJ-6379 is in development for chronic hepatitis B treatment, and may translate into higher HBV functional cure rates.
- || JNJ-56136379 / J&J
Clinical, P1 data, Journal: JNJ-56136379, an HBV Capsid Assembly Modulator, is Well-Tolerated and Has Antiviral Activity in a Phase 1 Study of Patients with Chronic Infection. (Pubmed Central) - Apr 7, 2021
P1
The findings support a phase 2a study to evaluate JNJ-6379±nucleos(t)ide analogs in patients with chronic HBV infection, which is underway. ClinicalTrials.gov identifier: NCT02662712.
- || daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Biomarker, Enrollment open: INSIGHT: A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - Mar 18, 2021
P2, N=24, Recruiting, Sponsor: Janssen Research & Development, LLC
ClinicalTrials.gov identifier: NCT02662712. Not yet recruiting --> Recruiting
- || daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Enrollment open: PENGUIN: 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 (clinicaltrials.gov) - Feb 18, 2021
P2, N=20, Recruiting, Sponsor: Janssen Research & Development, LLC
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting