Status:
COMPLETED
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
Lead Sponsor:
Enyo Pharma
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This is a multi centre, two parallel arm, randomized, open-label, Phase 2a experimental study of oral Farnesoid X Receptor (FXR) modulator EYP001a to assess its safety and anti-viral effect when admin...
Detailed Description
In total 30 eligible patients will be enrolled and randomized at approximately 7 study sites. Patients will be randomized prior to study drug (EYP001a, ETV and peg-IFN) administration on Day 1 in the...
Eligibility Criteria
Inclusion
- Has given voluntary written informed consent before performance of any study related procedure.
- Are treatment naive or without HBV treatment for at least 60 days or 5 times the elimination half-life, whichever is longer.
- Patient has CHB:
- HBV DNA ≥ 20,000 IU/mL for HBeAg positive and ≥2'000 for HBeAg negative and
- HBsAg ≥ 2.5 log10 IU/mL.
- Has liver imaging to screen for hepatocellular carcinoma or concomitant pancreaticobiliary disease either in the prior 6 months or at screening.
- Patient 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.
Exclusion
- 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:
- ALT \> 2 × ULN, AST \> 2 × ULN
- INR \> 1.2 × ULN, (normal range is 0.8 to 1.2)
- Platelet count \< 100 G/L
- Estimated glomerular filtration rate \< 50 mL/min/1.73m2 (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 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04365933
Start Date
May 25 2020
End Date
November 29 2021
Last Update
August 25 2022
Active Locations (6)
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1
ENYO PHARMA Investigative site HK01
Hong Kong, Hong Kong
2
ENYO PHARMA Investigative site KR01
Busan, South Korea
3
ENYO PHARMA Investigative site TW03
Kaohsiung City, Taiwan
4
ENYO PHARMA Investigative site TW04
Kaohsiung City, Taiwan