This is a prospective, multi-centre, randomized, double-blind, placebo-controlled, Phase 2a experimental study of oral FXR modulator EYP001a/placebo combined with NAs in virologically suppressed CHB patients to improve functional cure rates.
A total of 49 eligible patients will be enrolled and randomized at approximately 14 study sites. Patients will be randomized prior to study drug (EYP001a or placebo and NA) administration on Day 1 in the ratio of 3:1 into 2 arms: * Experimental Arm: EYP001a Dose A QD + NA daily (37 patients) * Control Arm: Placebo + NA daily (12 patients) The maximum total engagement duration for eligible patients in this study is up to 370 days: 90 days screening, 112 days (16 weeks) treatment period and 168 days (24 weeks) follow-up. Patients enrolled in the study will be assessed as outpatients. Patient screening will occur no more than 90 days prior to the Day 1 visit. Eligible patients will undergo further assessments on Day 1 to qualify for study drug administration on Day 1. The visits during the study are planned as below: * Screening visit: 12 weeks (90 days) * 16 weeks treatment period: * Treatment Visit 1 (Week 1 \[Day 1\]) * Treatment Visit 2 (Week 2 \[Day 14 ±3 days\]) * Treatment Visit 3 (Week 4 \[Day 28 ±3 days\]) * Treatment Visit 4 (Week 6 \[Day 42 ±3 days\]) * Treatment Visit 5 (Week 8 \[Day 56 ±3 days\]) * Treatment Visit 6 (Week 10 \[Day 70 ± 3 days\]) * Treatment Visit 7 (Week 12 \[Day 84 ± 3 days\]) * Treatment Visit 8 (Week 14 \[Day 98 ± 3 days\]) * Treatment Visit 9 (Week 16 \[Day 112±3 days\]) * 24 weeks safety follow-up period: * Follow-up Visit 1 (Week 20 \[Day 140 ±7 days\]) * Follow-up Visit 2 (Week 28 \[Day 196 ±7 days\]) * Follow-up Visit 3 (Week 40 \[Day 280 ±7 days\]) Note: during follow-up patients are kept on NA until the end of the trial: Week 40 (consolidation Phase).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
26
ENYO PHARMA Investigative site AU02
Brisbane, Australia
ENYO PHARMA Investigative site AU01
Melbourne, Australia
HBsAg Change (Δ log10) From Day 1 to Week 16 of Treatment
Efficacy of Vonafexor on top of NA assessed as HBsAg decline (Δ log10) from Day 1 to Week 16 of treatment
Time frame: LS mean at week 16 (Day 1, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, and Week 16)
Virologic Failure Rate
Virologic failure rate (breakthrough)2 of HBV-DNA (% patients with a confirmed quantifiable HBV DNA increase of ≥ 1log10 HBV DNA copies/mL above LLOQ3) assessed at Week 16 of treatment period and Weeks 20, 28 and 40 during follow-up period
Time frame: 40 weeks
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ENYO PHARMA Investigative site AU03
Melbourne, Australia
ENYO PHARMA Investigative site AU04
Melbourne, Australia
ENYO PHARMA Investigative site HK01
Hong Kong, Hong Kong
ENYO PHARMA Investigative site PL01
Bialystok, Poland
ENYO PHARMA Investigative site PL06
Kielce, Poland
ENYO PHARMA Investigative site PL05
Lodz, Poland
ENYO PHARMA Investigative site PL02
Lublin, Poland
ENYO PHARMA Investigative site PL03
Warsaw, Poland
...and 8 more locations