Study of EYP001a to Assess Its Safety and Anti-viral Effect in CHB Patients in Combination With NA (ETV or TD)
NCT ID: NCT04465916
Last Updated: 2022-11-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
26 participants
INTERVENTIONAL
2020-05-12
2021-11-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of the Safety and Pharmacology of EYP001 in HBV Subjects
NCT03272009
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
NCT04365933
Drug Drug Interaction Study for EYP001 With Entecavir
NCT03469583
A Study Evaluating Treatment Intensification With ABI-H0731 in Participants With Chronic Hepatitis B Infection on Nucleos(t)Ide Reverse Transcriptase Inhibitors
NCT04454567
A Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Participants With Chronic Hepatitis B Virus Infection (cHBV)
NCT03577171
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Experimental Arm: EYP001a Dose A QD + NA daily (37 patients)
* Control Arm: Placebo + NA daily (12 patients)
The maximum total engagement duration for eligible patients in this study is up to 370 days: 90 days screening, 112 days (16 weeks) treatment period and 168 days (24 weeks) follow-up.
Patients enrolled in the study will be assessed as outpatients. Patient screening will occur no more than 90 days prior to the Day 1 visit. Eligible patients will undergo further assessments on Day 1 to qualify for study drug administration on Day 1.
The visits during the study are planned as below:
* Screening visit: 12 weeks (90 days)
* 16 weeks treatment period:
* Treatment Visit 1 (Week 1 \[Day 1\])
* Treatment Visit 2 (Week 2 \[Day 14 ±3 days\])
* Treatment Visit 3 (Week 4 \[Day 28 ±3 days\])
* Treatment Visit 4 (Week 6 \[Day 42 ±3 days\])
* Treatment Visit 5 (Week 8 \[Day 56 ±3 days\])
* Treatment Visit 6 (Week 10 \[Day 70 ± 3 days\])
* Treatment Visit 7 (Week 12 \[Day 84 ± 3 days\])
* Treatment Visit 8 (Week 14 \[Day 98 ± 3 days\])
* Treatment Visit 9 (Week 16 \[Day 112±3 days\])
* 24 weeks safety follow-up period:
* Follow-up Visit 1 (Week 20 \[Day 140 ±7 days\])
* Follow-up Visit 2 (Week 28 \[Day 196 ±7 days\])
* Follow-up Visit 3 (Week 40 \[Day 280 ±7 days\]) Note: during follow-up patients are kept on NA until the end of the trial: Week 40 (consolidation Phase).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental Arm
Experimental Arm: EYP001a Dose A QD + NA daily (37 patients)
EYP001a
Oral tablets
Nucleotide analogue (Entecavir or Tenofovir Disoproxil)
Oral tablets
Control Arm
Control Arm: Placebo + NA daily (12 patients)
Placebo
Oral tablets
Nucleotide analogue (Entecavir or Tenofovir Disoproxil)
Oral tablets
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
EYP001a
Oral tablets
Placebo
Oral tablets
Nucleotide analogue (Entecavir or Tenofovir Disoproxil)
Oral tablets
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novotech (Australia) Pty Limited
INDUSTRY
Synteract, Inc.
INDUSTRY
Eurofins
INDUSTRY
Parexel
INDUSTRY
Enyo Pharma
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
ENYO PHARMA Investigative site KR04
Role: PRINCIPAL_INVESTIGATOR
Pusan, South Korea
ENYO PHARMA Investigative site KR03
Role: PRINCIPAL_INVESTIGATOR
Seoul, South Korea
ENYO PHARMA Investigative site KR02
Role: PRINCIPAL_INVESTIGATOR
Seoul, South Korea
ENYO PHARMA Investigative site KR01
Role: PRINCIPAL_INVESTIGATOR
Seoul, South Korea
ENYO PHARMA Investigative site PL06
Role: PRINCIPAL_INVESTIGATOR
Kielce, Poland
ENYO PHARMA Investigative site PL05
Role: PRINCIPAL_INVESTIGATOR
Łódź, Poland
ENYO PHARMA Investigative site PL04
Role: PRINCIPAL_INVESTIGATOR
Zawiercie, Poland
ENYO PHARMA Investigative site PL03
Role: PRINCIPAL_INVESTIGATOR
Warszawa, Poland
ENYO PHARMA Investigative site PL02
Role: PRINCIPAL_INVESTIGATOR
Lublin, Poland
ENYO PHARMA Investigative site PL01
Role: PRINCIPAL_INVESTIGATOR
Białystok, Poland
ENYO PHARMA Investigative site AU04
Role: PRINCIPAL_INVESTIGATOR
Melbourne, Australia
ENYO PHARMA Investigative site AU03
Role: PRINCIPAL_INVESTIGATOR
Melbourne, Australia
ENYO PHARMA Investigative site AU02
Role: PRINCIPAL_INVESTIGATOR
Brisbane, Australia
ENYO PHARMA Investigative site AU01
Role: PRINCIPAL_INVESTIGATOR
Melbourne, Australia
ENYO PHARMA Investigative site HK01
Role: PRINCIPAL_INVESTIGATOR
Hong Kong, Hong Kong
ENYO PHARMA Investigative site KR05
Role: PRINCIPAL_INVESTIGATOR
Seongnam, South Korea
ENYO PHARMA Investigative site KR06
Role: PRINCIPAL_INVESTIGATOR
Séoul, South Korea
ENYO PHARMA Investigative site KR07
Role: PRINCIPAL_INVESTIGATOR
Pusan, South Korea
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
ENYO PHARMA Investigative site AU02
Brisbane, , Australia
ENYO PHARMA Investigative site AU01
Melbourne, , Australia
ENYO PHARMA Investigative site AU03
Melbourne, , Australia
ENYO PHARMA Investigative site AU04
Melbourne, , Australia
ENYO PHARMA Investigative site HK01
Hong Kong, , Hong Kong
ENYO PHARMA Investigative site PL01
Bialystok, , Poland
ENYO PHARMA Investigative site PL06
Kielce, , Poland
ENYO PHARMA Investigative site PL05
Lodz, , Poland
ENYO PHARMA Investigative site PL02
Lublin, , Poland
ENYO PHARMA Investigative site PL03
Warsaw, , Poland
ENYO PHARMA Investigative site PL04
Zawiercie, , Poland
ENYO PHARMA Investigative site KR04
Pusan, , South Korea
ENYO PHARMA Investigative site KR07
Pusan, , South Korea
ENYO PHARMA Investigative site KR05
Seongnam, , South Korea
ENYO PHARMA Investigative site KR01
Seoul, , South Korea
ENYO PHARMA Investigative site KR02
Seoul, , South Korea
ENYO PHARMA Investigative site KR03
Seoul, , South Korea
ENYO PHARMA Investigative site KR06
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EYP001-201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.