Status:
TERMINATED
Study of EYP001a to Assess Its Safety and Anti-viral Effect in CHB Patients in Combination With NA (ETV or TD)
Lead Sponsor:
Enyo Pharma
Collaborating Sponsors:
Novotech (Australia) Pty Limited
Synteract, Inc.
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 p...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Main
- 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
- 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:
- Estimated glomerular filtration rate \<60 mL/min/1.73 m2 (the Modification of Diet in Renal Disease formula).
- Thyroid-stimulating hormone \>1.5× ULN or abnormal free triiodothyronine or free thyroxine.
Key Trial Info
Start Date :
May 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2021
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04465916
Start Date
May 12 2020
End Date
November 25 2021
Last Update
November 2 2022
Active Locations (18)
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1
ENYO PHARMA Investigative site AU02
Brisbane, Australia
2
ENYO PHARMA Investigative site AU01
Melbourne, Australia
3
ENYO PHARMA Investigative site AU03
Melbourne, Australia
4
ENYO PHARMA Investigative site AU04
Melbourne, Australia