A Study of the Oral Farnesoid X Receptor Modulator EYP001a to Assess Its Safety and Anti-viral Effect in Chronic Hepatitis B Patients in Combination With Pegylated Interferon alpha2a Alone and With Entecavir

Exclusion Criteria

• •Is an employee of a clinical research organization, vendor, or Sponsor involved with this study.
• •Has known hepatocellular carcinoma or pancreaticobiliary disease.
• •Neutropenia (defined by two confirmed values during Screening period of \< 1500/μL).
• •Has Gilbert syndrome.
• •Shows evidence of worsening liver tests, defined as either a confirmed (2 assessments at least 3 days apart) increase \> 2 ULN ALT or AST or an increase of \> 1.5 × baseline 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 F4 stage with a vibration controlled transient elastography (VCTE) \> 11.7 kPa leads to exclusion
• •Has known history of alcohol abuse or daily heavy alcohol consumption
• •Has any of the following exclusionary laboratory results at screening:
• •1. ALT \> 2 × ULN, AST \> 2 × ULN
• •2. INR \> 1.2 × ULN, (normal range is 0.8 to 1.2)
• •3. Platelet count \< 100 G/L
• •4. Estimated glomerular filtration rate \< 50 mL/min/1.73m2 (the Modification of Diet in Renal Disease formula)
• •5. Thyroid-stimulating hormone \> 1.5 × ULN or abnormal free triiodothyronine or free thyroxine.