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Four-part, Randomized, Double-blind (Parts 1, 2A, 3 and 4), Multi-center, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK3965193 Monotherapy in Healthy Participants and in Participants Living with Chronic Hepatitis B Infection; and GSK3965193 in Combination with Bepirovirsen in Participants Living with Chronic Hepatitis B Infection

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509684-24-00
Acronym
214760
Enrollment
24
Registered
2024-08-20
Start date
2024-10-31
Completion date
2025-12-16
Last updated
2025-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B

Brief summary

Incidence of AEs, SAEs, withdrawals due to AEs, Incidence of clinically significant laboratory parameters (haematology, clinical chemistry, urinalysis), vital signs, cardiac parameters (electrocardiogram), and sensory nerve conduction, In Part 3 - Maximum reduction of serum HBsAg levels from baseline over 6 weeks (4 weeks on treatment and 2 weeks post-treatment), In Part 4 - Achieving complete response (undetectable serum HBV DNA and HBsAg for 6 consecutive months after the planned end of treatment of bepirovirsen)

Detailed description

In Part 3 - AUC(0-tau), Cmax, Tmax, and apparent terminal half-life (T1/2) will be calculated as data permits, In Part 3 - >=0.5x log IU/mL reduction of serum HBsAg levels from baseline anytime during the study (on-treatment and post-treatment), In Part 3 - Incidence of AEs, SAEs, withdrawals due to AEs and incidence of clinically significant laboratory parameters (haematology, clinical chemistry, urinalysis) and vital signs occurring in participants taking bepirovirsen monotherapy after completing GSK3965193/placebo monotherapy, In Part 4 - HBsAg loss (defined by two consecutive measurements of HBsAg below the limit of quantification) anytime during the study (on-treatment and post-treatment)

Interventions

DRUGPlacebo to Match GSK3965193 Tablets

Sponsors

Glaxosmithkline Research & Development Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Incidence of AEs, SAEs, withdrawals due to AEs, Incidence of clinically significant laboratory parameters (haematology, clinical chemistry, urinalysis), vital signs, cardiac parameters (electrocardiogram), and sensory nerve conduction, In Part 3 - Maximum reduction of serum HBsAg levels from baseline over 6 weeks (4 weeks on treatment and 2 weeks post-treatment), In Part 4 - Achieving complete response (undetectable serum HBV DNA and HBsAg for 6 consecutive months after the planned end of treatment of bepirovirsen)

Secondary

MeasureTime frame
In Part 3 - AUC(0-tau), Cmax, Tmax, and apparent terminal half-life (T1/2) will be calculated as data permits, In Part 3 - >=0.5x log IU/mL reduction of serum HBsAg levels from baseline anytime during the study (on-treatment and post-treatment), In Part 3 - Incidence of AEs, SAEs, withdrawals due to AEs and incidence of clinically significant laboratory parameters (haematology, clinical chemistry, urinalysis) and vital signs occurring in participants taking bepirovirsen monotherapy after completing GSK3965193/placebo monotherapy, In Part 4 - HBsAg loss (defined by two consecutive measurements of HBsAg below the limit of quantification) anytime during the study (on-treatment and post-treatment)

Countries

France, Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026