Last updated: 06/03/2024 06:30:14
Modeling and simulation analysis for BEPIROVIRSEN
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Reporting and Analysis Plan for the population pharmacokinetic and PKPD analyses for bepirovirsen (GSK3228836) for the treatment of Chronic Hepatitis B
Trial description: This study will establish the population pharmacokinetics (PK) and PK-Pharmacodynamics (PD) models of BEPIROVIRSEN in chronic Hepatitis B (CHB) participants in order to inform design and dose selection of Phase 3 studies in CHB participants. This is a pooled analysis conducted using data from studies 213725 (ISIS 505358-CS1), 205695 (NCT02981602) and 209668 (NCT04449029). BEPIROVIRSEN is a trademark of the GlaxoSmithKline group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Population pharmacokinetic (PPK) model for BEPIROVIRSEN (GSK3228836) in plasma
Timeframe: Up to 1 year
Pharmacokinetic-Pharmacodynamic (PKPD) model(s) describing the exposure Hepatitis B surface antigen (HBsAg)- Alanine transaminase (ALT) relationship
Timeframe: Up to 1 year
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2023-09-01
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Amir S Youssef, Mohamed Ismail, Kelong Han, Mindy Magee, Ahmed Nader. Population Pharmacokinetics of Bepirovirsen in Healthy Participants and Participants with Chronic Hepatitis B Virus Infection: Results from Phase 1, 2a, and 2b Studies.. Infectious diseases and therapy. 2024-May-25;
DOI : 10.1007/s40121-024-00980-9
PMID: 38796564
Medical condition
Hepatitis B
Product
Not applicable
Collaborators
Not applicable
Study date(s)
October 2021 to January 2023
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- For PPK analysis: Participants with data available for BEPIROVIRSEN concentrations in plasma with the associated dosing dates, times, amounts and sampling dates and times. Dosing and sampling records are chronologically consistent within participants.
- For PPK-PD analysis: Participants with data for efficacy and safety endpoints of interest with the associated dosing dates, times, amounts and sampling dates and times.
- Not available
Inclusion and exclusion criteria
Inclusion criteria:
- For PPK analysis: Participants with data available for BEPIROVIRSEN concentrations in plasma with the associated dosing dates, times, amounts and sampling dates and times. Dosing and sampling records are chronologically consistent within participants.
- For PPK-PD analysis: Participants with data for efficacy and safety endpoints of interest with the associated dosing dates, times, amounts and sampling dates and times.
- For covariate analysis: Participants with data available for selected demographic information, and for selected clinical and laboratory covariates.
Exclusion criteria:
- Not available
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2023-09-01
Actual study completion date
2023-09-01
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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