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

October 11, 2022 updated by: Enyo Pharma

A Phase 2a, Randomized, Double-blind, Placebo-controlled Study of Oral FXR Modulator EYP001a Combined With Nucleos(t)Ide Analogues (NA) in Virologically Suppressed Chronic Hepatitis B Patients to Improve Functional Cure Rates

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 the ratio of 3:1 into 2 arms:

  • 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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Brisbane, Australia
        • ENYO PHARMA Investigative site AU02
      • Melbourne, Australia
        • ENYO PHARMA Investigative site AU01
      • Melbourne, Australia
        • ENYO PHARMA Investigative site AU03
      • Melbourne, Australia
        • ENYO PHARMA Investigative site AU04
  • Hong Kong
      • Hong Kong, Hong Kong
        • ENYO PHARMA Investigative site HK01
  • Korea, Republic of
      • Pusan, Korea, Republic of
        • ENYO PHARMA Investigative site KR04
      • Pusan, Korea, Republic of
        • ENYO PHARMA Investigative site KR07
      • Seongnam, Korea, Republic of
        • ENYO PHARMA Investigative site KR05
      • Seoul, Korea, Republic of
        • ENYO PHARMA Investigative site KR01
      • Seoul, Korea, Republic of
        • ENYO PHARMA Investigative site KR02
      • Seoul, Korea, Republic of
        • ENYO PHARMA Investigative site KR03
      • Séoul, Korea, Republic of
        • ENYO PHARMA Investigative site KR06
  • Poland
      • Białystok, Poland
        • ENYO PHARMA Investigative site PL01
      • Kielce, Poland
        • ENYO PHARMA Investigative site PL06
      • Lublin, Poland
        • ENYO PHARMA Investigative site PL02
      • Warszawa, Poland
        • ENYO PHARMA Investigative site PL03
      • Zawiercie, Poland
        • ENYO PHARMA Investigative site PL04
      • Łódź, Poland
        • ENYO PHARMA Investigative site PL05

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Main Inclusion Criteria:

  • 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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Arm
Experimental Arm: EYP001a Dose A QD + NA daily (37 patients)
Drug: EYP001a
Oral tablets
Drug: Nucleotide analogue (Entecavir or Tenofovir Disoproxil)
Oral tablets
Placebo Comparator: Control Arm
Control Arm: Placebo + NA daily (12 patients)
Drug: Placebo
Oral tablets
Drug: Nucleotide analogue (Entecavir or Tenofovir Disoproxil)
Oral tablets

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
HBsAg Change (Δ log10) From Day 1 to Week 16 of Treatment
Time Frame: LS mean at week 16 (Day 1, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, and Week 16)
Efficacy of Vonafexor on top of NA assessed as HBsAg decline (Δ log10) from Day 1 to Week 16 of treatment
LS mean at week 16 (Day 1, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, and Week 16)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Virologic Failure Rate
Time Frame: 40 weeks
Virologic failure rate (breakthrough)2 of HBV-DNA (% patients with a confirmed quantifiable HBV DNA increase of ≥ 1log10 HBV DNA copies/mL above LLOQ3) assessed at Week 16 of treatment period and Weeks 20, 28 and 40 during follow-up period
40 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Enyo Pharma

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Parexel
Novotech (Australia) Pty Limited
Synteract, Inc.
Eurofins

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: ENYO PHARMA Investigative site KR04, Pusan, South Korea
  • Principal Investigator: ENYO PHARMA Investigative site KR03, Séoul, South Korea
  • Principal Investigator: ENYO PHARMA Investigative site KR02, Séoul, South Korea
  • Principal Investigator: ENYO PHARMA Investigative site KR01, Séoul, South Korea
  • Principal Investigator: ENYO PHARMA Investigative site PL06, Kielce, Poland
  • Principal Investigator: ENYO PHARMA Investigative site PL05, Łódź, Poland
  • Principal Investigator: ENYO PHARMA Investigative site PL04, Zawiercie, Poland
  • Principal Investigator: ENYO PHARMA Investigative site PL03, Warszawa, Poland
  • Principal Investigator: ENYO PHARMA Investigative site PL02, Lublin, Poland
  • Principal Investigator: ENYO PHARMA Investigative site PL01, Białystok, Poland
  • Principal Investigator: ENYO PHARMA Investigative site AU04, Melbourne, Australia
  • Principal Investigator: ENYO PHARMA Investigative site AU03, Melbourne, Australia
  • Principal Investigator: ENYO PHARMA Investigative site AU02, Brisbane, Australia
  • Principal Investigator: ENYO PHARMA Investigative site AU01, Melbourne, Australia
  • Principal Investigator: ENYO PHARMA Investigative site HK01, Hong Kong, Hong Kong
  • Principal Investigator: ENYO PHARMA Investigative site KR05, Seongnam, South Korea
  • Principal Investigator: ENYO PHARMA Investigative site KR06, Séoul, South Korea
  • Principal Investigator: ENYO PHARMA Investigative site KR07, Pusan, South Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 17, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 25, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EYP001-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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