JNJ-64300535
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July 18, 2024
OSPREY: A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection
(clinicaltrials.gov)
- P1 | N=24 | Completed | Sponsor: Janssen Research & Development, LLC | Active, not recruiting ➔ Completed
Trial completion • Hepatitis B • Hepatology • Infectious Disease • Inflammation
April 30, 2024
Efficacy, safety, tolerability, and immunogenicity of JNJ-0535 following a reduction of viral antigen levels through administration of siRNA JNJ-3989 in patients with chronic HBeAg negative hepatitis B - interim data of the OSPREY study
(EASL-ILC 2024)
- P1 | "Treatment with JNJ-3989, JNJ-0535 and NA, continued or stopped was generally safe and well tolerated. HBsAg lowering, followed by vaccination in OSPREY, showed more favourable HBsAg kinetics during FU in patients that were able to stop NA treatment versus patients who continued NA treatment. A potential role of HBV specific polypositive CD4 T cells needs further elucidation."
Clinical • Late-breaking abstract • Hepatitis B • Hepatology • Infectious Disease • Inflammation • CD4
February 16, 2024
OSPREY: A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection
(clinicaltrials.gov)
- P1 | N=24 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Jun 2024 ➔ Jul 2023
Trial primary completion date • Hepatitis B • Hepatology • Infectious Disease • Inflammation
December 06, 2023
OSPREY: A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection
(clinicaltrials.gov)
- P1 | N=24 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Phase classification: P1b ➔ P1
Phase classification • Hepatitis B • Hepatology • Infectious Disease • Inflammation
November 23, 2022
OSPREY: A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection
(clinicaltrials.gov)
- P1b | N=24 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting
Enrollment closed • Hepatitis B • Hepatology • Infectious Disease • Inflammation
October 26, 2022
OSPREY: A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection
(clinicaltrials.gov)
- P1b | N=23 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: May 2023 ➔ Aug 2024
Trial primary completion date • Hepatitis B • Hepatology • Infectious Disease • Inflammation
May 12, 2022
Therapeutic vaccine JNJ-0535 induces a strong HBV-specific T-cell response in healthy adults and a modest response in chronic HBV-infected patients
(EASL-ILC 2022)
- "T cell responses induced in HV were superior to those in CHB patients at a JNJ-0535 dose of 6 mg in terms of the proportion of responders, the magnitude of fold-increase from baseline, the breadth (number of antigens) and CD4+ and CD8+ core-specific T cell polyfunctionality. This supports the hypothesis that CHB infection negatively impacts the ability of patients to induce T cells in response to therapeutic vaccination."
Clinical • Hepatitis B • Hepatology • Inflammation • CD4 • CD8 • IFNG
January 28, 2022
OSPREY: A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection
(clinicaltrials.gov)
- P1b | N=23 | Recruiting | Sponsor: Janssen Research & Development, LLC | Not yet recruiting ➔ Recruiting
Enrollment open • Hepatitis B • Hepatology • Infectious Disease • Inflammation
December 22, 2021
A Study of JNJ-64300535 in Healthy Participants
(clinicaltrials.gov)
- P1; N=14; Completed; Sponsor: Janssen Research & Development, LLC; Active, not recruiting ➔ Completed
Clinical • Trial completion • CD4 • CD8
November 17, 2021
OSPREY: A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection
(clinicaltrials.gov)
- P1b; N=23; Not yet recruiting; Sponsor: Janssen Research & Development, LLC
Clinical • New P1 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation
August 09, 2021
A Study of JNJ-64300535 in Healthy Participants
(clinicaltrials.gov)
- P1; N=14; Active, not recruiting; Sponsor: Janssen Research & Development, LLC; Recruiting ➔ Active, not recruiting
Enrollment closed • CD4 • CD8
April 14, 2021
A First-In-Human Study to Evaluate Safety, Tolerability, Reactogenicity, and Immunogenicity of JNJ-64300535, a DNA Vaccine, Administered by Electroporation-Mediated Intramuscular Injection, in Participants With Chronic Hepatitis B Who Are on Stable Nucleos(t)Ide Therapy and Virologically Suppressed
(clinicaltrials.gov)
- P1; N=30; Completed; Sponsor: Janssen Sciences Ireland UC; Active, not recruiting ➔ Completed
Trial completion • Hepatitis B • Hepatology • Infectious Disease • CD4 • CD8 • TNFA
February 21, 2021
A Study of JNJ-64300535 in Healthy Participants
(clinicaltrials.gov)
- P1; N=12; Recruiting; Sponsor: Janssen Research & Development, LLC; Not yet recruiting ➔ Recruiting
Clinical • Enrollment open • CD4 • CD8
February 03, 2021
A Study of JNJ-64300535 in Healthy Participants
(clinicaltrials.gov)
- P1; N=12; Not yet recruiting; Sponsor: Janssen Research & Development, LLC
Clinical • New P1 trial • CD4 • CD8
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