Study of EYP001a to Assess Its Safety and Anti-viral Effect in CHB Patients in Combination With NA (ETV or TD)
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis B; Hepatitis B, Chronic; Hepatitis
Intervention: EYP001a; Placebo; Nucleotide analogue (Entecavir or Tenofovir Disoproxil)
Intervention description: Oral tablets; Oral tablets; Oral tablets
Intervention MeSH terms: Tenofovir; Entecavir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Triple blind
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Are on stable NA therapy at least 12 months from the screening date (ETV or TDF)

          -  Has virally suppressed CHB:

        HBV DNA <LLOQ and serum HBsAg >100 IU/mL

          -  Has liver imaging to screen for hepatocellular carcinoma or concomitant
             pancreaticobiliary disease either in the prior 6 months or at screening.

          -  Is not of childbearing potential or, if of childbearing potential, is not pregnant as
             confirmed by a negative serum human chorionic gonadotropin test at screening and is
             not planning a pregnancy during the course of the study.

        Main Exclusion Criteria:

          -  Is an employee of a contract research organization (CRO), vendor, or Sponsor involved
             with this study.

          -  Has known hepatocellular carcinoma or pancreaticobiliary disease.

          -  Neutropenia (defined by two confirmed values within screening period of <1500/μL).

          -  Has Gilbert syndrome.

          -  Shows evidence of worsening liver function, defined as either a confirmed (two
             assessments at least 3 days apart) increase >2 ULN ALT or AST or an increase of >1.5 ×
             first assessed value of TBL or associated with clinical signs or symptoms of liver
             impairment.

          -  Has known or suspected non-CHB liver disease

          -  History of cirrhosis or liver decompensation, including ascites, hepatic
             encephalopathy, or presence of oesophageal varices.

          -  Probable or possible F3 stage with a vibration controlled transient elastography
             (VCTE). Patients with normal baseline ALT and VCTE >8.8 kPa are excluded. Patients
             with baseline ALT >ULN (but <2ULN per EC5) and who have VCTE >10.5 kPa at baseline are
             excluded 11.

          -  Has known history of alcohol abuse or daily heavy alcohol consumption

          -  Has clinically relevant immunosuppression, including, but not limited to,
             immunodeficiency conditions such as common variable hypogammaglobulinemia.

          -  Has used anti-HBV medications other than NAs within 90 days prior to screening.

          -  Has any of the following exclusionary laboratory results at screening:

               1. Estimated glomerular filtration rate <60 mL/min/1.73 m2 (the Modification of Diet
                  in Renal Disease formula).

               2. Thyroid-stimulating hormone >1.5× ULN or abnormal free triiodothyronine or free
                  thyroxine.