Study of EYP001a to Assess Its Safety and Anti-viral Effect in CHB Patients in Combination With NA (ETV or TD)

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Enyo Pharma
• Collaborators: Eurofins; Novotech (Australia) Pty Limited; Parexel; Synteract, Inc.
• Treatments: Entecavir; Tenofovir

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 DNA100 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.