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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04465916




Registration number
NCT04465916
Ethics application status
Date submitted
6/07/2020
Date registered
10/07/2020
Date last updated
2/11/2022

Titles & IDs
Public title
Study of EYP001a to Assess Its Safety and Anti-viral Effect in CHB Patients in Combination With NA (ETV or TD)
Scientific title
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
Secondary ID [1] 0 0
EYP001-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B, Chronic 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - EYP001a
Treatment: Drugs - Placebo
Treatment: Drugs - Nucleotide analogue (Entecavir or Tenofovir Disoproxil)

Experimental: Experimental Arm - Experimental Arm: EYP001a Dose A QD + NA daily (37 patients)

Placebo Comparator: Control Arm - Control Arm: Placebo + NA daily (12 patients)


Treatment: Drugs: EYP001a
Oral tablets

Treatment: Drugs: Placebo
Oral tablets

Treatment: Drugs: Nucleotide analogue (Entecavir or Tenofovir Disoproxil)
Oral tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
HBsAg Change (? log10) From Day 1 to Week 16 of Treatment
Timepoint [1] 0 0
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 [1] 0 0
Virologic Failure Rate
Timepoint [1] 0 0
40 weeks

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/05/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/11/2021
Sample size
Target
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
ENYO PHARMA Investigative site AU02 - Brisbane
Recruitment hospital [2] 0 0
ENYO PHARMA Investigative site AU01 - Melbourne
Recruitment hospital [3] 0 0
ENYO PHARMA Investigative site AU03 - Melbourne
Recruitment hospital [4] 0 0
ENYO PHARMA Investigative site AU04 - Melbourne
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Hong Kong
Country [2] 0 0
Korea, Republic of
State/province [2] 0 0
Pusan
Country [3] 0 0
Korea, Republic of
State/province [3] 0 0
Seongnam
Country [4] 0 0
Korea, Republic of
State/province [4] 0 0
Seoul
Country [5] 0 0
Korea, Republic of
State/province [5] 0 0
Séoul
Country [6] 0 0
Poland
State/province [6] 0 0
Bialystok
Country [7] 0 0
Poland
State/province [7] 0 0
Kielce
Country [8] 0 0
Poland
State/province [8] 0 0
Lublin
Country [9] 0 0
Poland
State/province [9] 0 0
Warszawa
Country [10] 0 0
Poland
State/province [10] 0 0
Zawiercie
Country [11] 0 0
Poland
State/province [11] 0 0
Lódz

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Enyo Pharma
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Synteract, Inc.
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/Industry
Name [3] 0 0
Eurofins
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Commercial sector/Industry
Name [4] 0 0
Parexel
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
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 patients to improve functional cure rates.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04465916
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ENYO PHARMA Investigative site KR04
Address 0 0
Pusan, South Korea
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04465916