Study of EYP001a to Assess Its Safety and Anti-viral Effect in CHB Patients in Combination With NA (ETV or TD)
NCT04465916 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2022-11-02
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.
Conditions
- Hepatitis B, Chronic
Interventions
- DRUG
-
EYP001a
Oral tablets
- DRUG
-
Oral tablets
- DRUG
-
Nucleotide analogue (Entecavir or Tenofovir Disoproxil)
Oral tablets
Sponsors & Collaborators
-
Novotech (Australia) Pty Limited
collaborator INDUSTRY -
Synteract, Inc.
collaborator INDUSTRY -
Eurofins
collaborator INDUSTRY -
Parexel
collaborator INDUSTRY -
Enyo Pharma
lead INDUSTRY
Principal Investigators
-
ENYO PHARMA Investigative site KR04 · Pusan, South Korea
-
ENYO PHARMA Investigative site KR03 · Seoul, South Korea
-
ENYO PHARMA Investigative site KR02 · Seoul, South Korea
-
ENYO PHARMA Investigative site KR01 · Seoul, South Korea
-
ENYO PHARMA Investigative site PL06 · Kielce, Poland
-
ENYO PHARMA Investigative site PL05 · Łódź, Poland
-
ENYO PHARMA Investigative site PL04 · Zawiercie, Poland
-
ENYO PHARMA Investigative site PL03 · Warszawa, Poland
-
ENYO PHARMA Investigative site PL02 · Lublin, Poland
-
ENYO PHARMA Investigative site PL01 · Białystok, Poland
-
ENYO PHARMA Investigative site AU04 · Melbourne, Australia
-
ENYO PHARMA Investigative site AU03 · Melbourne, Australia
-
ENYO PHARMA Investigative site AU02 · Brisbane, Australia
-
ENYO PHARMA Investigative site AU01 · Melbourne, Australia
-
ENYO PHARMA Investigative site HK01 · Hong Kong, Hong Kong
-
ENYO PHARMA Investigative site KR05 · Seongnam, South Korea
-
ENYO PHARMA Investigative site KR06 · Séoul, South Korea
-
ENYO PHARMA Investigative site KR07 · Pusan, South Korea
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-05-12
- Primary Completion
- 2021-06-17
- Completion
- 2021-11-25
- FDA Drug
- Yes
Countries
- Australia
- Hong Kong
- Poland
- South Korea
Study Locations
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