At a glance
ClinicalIndex Comparison Record- ✓Age 18-70 years at informed consent
- ✓Documented chronic HBV infection for ≥6 months prior to screening
- ✓HBsAg concentration >50 IU/mL
- ✓For Part 1: treatment-naive or prior interferon therapy ended ≥6 months before Day 1, or on stable nucleos(t)ide therapy with no regimen changes for ≥6 months
- ✕Moderate to severe liver disease other than CHB (autoimmune hepatitis, NASH, hemochromatosis, liver failure)
- ✕Significant or unstable cardiac disease (prolonged QT syndrome, angina, CHF, MI, diastolic dysfunction, arrhythmia, coronary disease, or clinically significant ECG abnormalities)
- ✕HCV, HIV, or HDV co-infection
- ✕Cirrhosis or evidence thereof: Metavir F4 on biopsy within 12 months, Fibroscan >12 kPa within 12 months, or APRI >2 and FibroSure >0.7 within 12 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Dose and Multiple Doses of GSK3389404 in Chronic Hepatitis B Subjects
In Brief
A Phase 2 clinical trial evaluating GSK3389404 and Placebo for Hepatitis B. Completed, enrolled 78 participants across 21 sites in 6 countries.
Detailed Summary
GSK3389404 is being developed for the treatment of CHB virus infection. The development goal for GSK3389404 is the establishment of a finite duration treatment that results in sustained suppression of hepatitis B virus (HBV) replication and viral antigen production after cessation of all treatments for CHB due to the restoration of a functional immune response in the absence of high antigen levels. This study is a multicenter, randomized double-Blind (sponsor un-blinded in Part 1), Placebo-controlled Study which will evaluate the safety, tolerability, PK, and PD profile of GSK3389404 in subjects with CHB and aim to establish proof-of-mechanism. The study will be conducted in two parts. Part 1 plans to enroll subjects primarily from the Asia-pacific region, including Japan and will be conducted as a single ascending dose (SAD) study with 5 planned cohorts ranging from 30 milligram (mg) to a maximum of 240 mg GSK3389404. Within each cohort, subjects will be randomized to receive either GSK3389404 or placebo in a 3:1 ratio. Cohorts A, B, C, C1, and D will be conducted in a sequential fashion; Cohort C1 is an optional cohort and may be dosed after Cohort C or in parallel with Cohort D. Part 2 will be conducted as a multiple-dose, dose-ranging study. Subjects will be randomized to different parallel dose levels and regimens or placebo. The dose levels of Part 2 will be selected after a review of Part 1 safety, Pharmacokinetic (PK) and Pharmacodynamic (PD) data. The treatments selected are 60 mg GSK3389404 weekly, 120 mg GSK3389404 bi-weekly, 120 mg GSK3389404 weekly or placebo. An optional Japanese part-2 sub-study is planned. The total study duration for part 1 including screening, treatment, and post-treatment follow-up, will not be expected to exceed 13 weeks for each subject and for part 2, including screening, treatment and post-treatment follow-up, will not be expected to exceed 65 weeks for each subject.
Study Details
Timeline
Interventions
GSK3389404 is available as Clear colorless to slightly yellow solution for injection.
Placebo is available as a Clear colorless solution.