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0 Diseases |  |
1 Trial |
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1 Trial |  |
6 News |  |
- bepirovirsen (GSK3228836) / GSK
Nonclinical phenotypic evaluation of clinically identified baseline and treatment-emergent hepatitis B Virus variants that contain single nucleotide polymorphisms in the bepirovirsen binding site (Poster Area) - Apr 2, 2024 - Abstract #EASLILC2024EASL_ILC_2245;
P2b
The biological basis for varying levels of fitness of each variant, through potential impact of SNPs on HBx and HBV DNA polymerase function, is under evaluation. While the frequency of these HBV variants is very low, the relevance of the in vitro phenotypic data to clinical outcome is subject to further investigation.
- bepirovirsen (GSK3228836) / GSK
A primary human hepatocyte system to evaluate antisense oligonucleotide activity against clinically identified hepatitis b virus variants that contain mismatches in the bepirovirsen binding site (Poster Area) - Apr 12, 2023 - Abstract #EASLILC2023EASL_ILC_1704;
P2b
Using this system, a few HBV variants identified from B-Clear baseline samples were evaluated. Clinical relevance of HBV variants with reduced susceptibility is under investigation.
- | bepirovirsen (GSK3228836) / GSK, GSK3389404 / GSK
Journal: Reply to: Bepirovirsen / GSK3389404: antisense or TLR9 agonists? (Pubmed Central) - Mar 2, 2023
Clinical relevance of HBV variants with reduced susceptibility is under investigation. No abstract available
- | bepirovirsen (GSK3228836) / GSK, GSK3389404 / GSK
Journal: Bepirovirsen / GSK3389404: antisense or TLR9 agonists? (Pubmed Central) - Mar 2, 2023
No abstract available No abstract available
- || GSK3389404 / GSK
Clinical, PK/PD data, Journal: Comparison of Pharmacokinetics of the GalNAc-Conjugated Antisense Oligonucleotide GSK3389404 in Participants with Chronic Hepatitis B Infection across the Asia-Pacific Region. (Pubmed Central) - Dec 13, 2022
P2
The GSK3389404 plasma concentration versus time profiles, half-life, t, C, and AUC values were all comparable across the Asia-Pacific populations. Given the similarity of the PK among ASOs, this analysis suggests that the PK from any Asia-Pacific population may be used to guide ASO dose selection in the Asia-Pacific region.
- || GSK3389404 / GSK
P2a data, Journal: Phase IIa, randomised, double-blind study of GSK3389404 in patients with chronic hepatitis B on stable nucleos(t)ide therapy. (Pubmed Central) - Jun 22, 2022
P2
GSK3389404 showed an acceptable safety profile and target engagement, with dose-dependent reductions in HBsAg. However, no efficacious dosing regimen was identified.
- bepirovirsen (GSK3228836) / GSK
Bepirovirsen, antisense oligonucleotide (ASO) against hepatitis B virus (HBV), harbors intrinsic immunostimulatory activity via Toll-like receptor 8 (TLR8) preclinically, correlating with clinical efficacy from the Phase 2a study (Poster Area) - May 12, 2022 - Abstract #EASLILC2022EASL_ILC_1829;
P2
Cytokines/chemokines changed by BPV treatment in the Phase 2a study indicate that an immunostimulatory activity of BPV via TLR8 may be correlated with ASO-mediated HBsAg reduction. These findings support further investigation of a combination of HBsAg reducing agent and TLR8 agonist for treating HBV.
- || GSK3389404 / GSK
Clinical, PK/PD data, Journal: A Randomized, Double-Blind, Placebo-Controlled, First-Time-in-Human Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of GSK3389404 in Healthy Subjects. (Pubmed Central) - Jul 29, 2020
In the pooled urine, GSK3389404 was estimated to account for <0.1% of the total dose. In summary, GSK3389404 dosing has been tested up to 120 mg for 4 weeks with an acceptable safety and pharmacokinetic profile, supporting further clinical investigation in patients with chronic hepatitis B.
- ||| GSK3389404 / GSK
Trial completion: A Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK3389404 in Chronic Hepatitis B (CHB) Subjects (clinicaltrials.gov) - Jan 22, 2020
P2, N=78, Completed, Sponsor: GlaxoSmithKline
In summary, GSK3389404 dosing has been tested up to 120 mg for 4 weeks with an acceptable safety and pharmacokinetic profile, supporting further clinical investigation in patients with chronic hepatitis B. Active, not recruiting --> Completed
- GSK3389404 / GSK
RESULTS AFTER 12 WEEKS TREATMENT OF MULTIPLE DOSES OF GSK3389404 IN CHRONIC HEPATITIS B (CHB) SUBJECTS ON STABLE NUCLEOS(T)IDE THERAPY IN A PHASE 2a DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY (Hynes Convention Center, Hall B) - Sep 29, 2019 - Abstract #AASLD2019AASLD_1132;
P2
GSK404 had an acceptable safety profile and showed target engagement with dose-dependent declines in mean HBsAg. The Phase 2a study is ongoing with subjects in an optional post-treatment period.
- ||| GSK3389404 / GSK
Enrollment closed, Phase classification, Enrollment change: A Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK3389404 in Chronic Hepatitis B (CHB) Subjects (clinicaltrials.gov) - Feb 18, 2019
P2, N=78, Active, not recruiting, Sponsor: GlaxoSmithKline
The Phase 2a study is ongoing with subjects in an optional post-treatment period. Recruiting --> Active, not recruiting | Phase classification: P1/2 --> P2 | N=150 --> 78
- | GSK3389404 / GSK
Phase classification, Trial completion date: A Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK3389404 in Chronic Hepatitis B (CHB) Subjects (clinicaltrials.gov) - Jan 10, 2019
P1/2, N=150, Recruiting, Sponsor: GlaxoSmithKline
Recruiting --> Active, not recruiting | Phase classification: P1/2 --> P2 | N=150 --> 78 Phase classification: P2 --> P1/2 | Trial completion date: Jan 2019 --> Nov 2019
- ||| GSK3389404 / GSK
Enrollment change, Trial primary completion date: A Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK3389404 in Chronic Hepatitis B (CHB) Subjects (clinicaltrials.gov) - Sep 7, 2017
P2, N=150, Recruiting, Sponsor: GlaxoSmithKline
Phase classification: P2 --> P1/2 | Trial completion date: Jan 2019 --> Nov 2019 N=120 --> 150 | Trial primary completion date: Feb 2018 --> Nov 2018
- |||| GSK3389404 / GSK
Enrollment open: A Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK3389404 in Chronic Hepatitis B (CHB) Subjects (clinicaltrials.gov) - Mar 19, 2017
P2, N=120, Recruiting, Sponsor: GlaxoSmithKline
N=120 --> 150 | Trial primary completion date: Feb 2018 --> Nov 2018 Not yet recruiting --> Recruiting
- ||| GSK3389404 / GSK
Trial completion: First Time in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of GSK3389404 in Healthy Subjects (clinicaltrials.gov) - Jan 26, 2017
P1, N=56, Completed, Sponsor: GlaxoSmithKline
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- ||||| GSK3389404 / GSK
New P2 trial: A Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK3389404 in Chronic Hepatitis B (CHB) Subjects (clinicaltrials.gov) - Jan 18, 2017
P2, N=120, Not yet recruiting, Sponsor: GlaxoSmithKline
- || GSK3389404 / GSK
Enrollment closed: First Time in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of GSK3389404 in Healthy Subjects (clinicaltrials.gov) - Nov 2, 2016
P1, N=56, Active, not recruiting, Sponsor: GlaxoSmithKline
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- ||| GSK3389404 / GSK
New P1 trial: First Time in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of GSK3389404 in Healthy Subjects (clinicaltrials.gov) - Jan 6, 2016
P1, N=56, Recruiting, Sponsor: GlaxoSmithKline