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

NCT04465916 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: EYP001-201
• Study Type: interventional
• Target: 26
• Locations: 4 countries
• Sites: 18

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.

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

• HBsAg Change (Δ log10) From Day 1 to Week 16 of Treatment

  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 Outcomes (1)

• Virologic Failure Rate

  40 weeks

Study Arms (2)

Experimental Arm

EXPERIMENTAL

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

Drug: EYP001a; Drug: Nucleotide analogue (Entecavir or Tenofovir Disoproxil)

Control Arm

PLACEBO COMPARATOR

Control Arm: Placebo + NA daily (12 patients)

Drug: Placebo; Drug: Nucleotide analogue (Entecavir or Tenofovir Disoproxil)

Interventions

EYP001a DRUG

Oral tablets

Experimental Arm

Placebo DRUG

Oral tablets

Control Arm

Nucleotide analogue (Entecavir or Tenofovir Disoproxil) DRUG

Oral tablets

Control Arm; Experimental Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Estimated glomerular filtration rate \<60 mL/min/1.73 m2 (the Modification of Diet in Renal Disease formula).
• Thyroid-stimulating hormone \>1.5× ULN or abnormal free triiodothyronine or free thyroxine.

Sponsors & Collaborators

• Enyo Pharma: lead
• Novotech (Australia) Pty Limited: collaborator
• Synteract, Inc.: collaborator
• Eurofins: collaborator
• Parexel: collaborator

Study Sites (18)

ENYO PHARMA Investigative site AU02

Brisbane, Australia

Location

ENYO PHARMA Investigative site AU01

Melbourne, Australia

Location

ENYO PHARMA Investigative site AU03

Melbourne, Australia

Location

ENYO PHARMA Investigative site AU04

Melbourne, Australia

Location

ENYO PHARMA Investigative site HK01

Hong Kong, Hong Kong

Location

ENYO PHARMA Investigative site PL01

Bialystok, Poland

Location

ENYO PHARMA Investigative site PL06

Kielce, Poland

Location

ENYO PHARMA Investigative site PL05

Lodz, Poland

Location

ENYO PHARMA Investigative site PL02

Lublin, Poland

Location

ENYO PHARMA Investigative site PL03

Warsaw, Poland

Location

ENYO PHARMA Investigative site PL04

Zawiercie, Poland

Location

ENYO PHARMA Investigative site KR04

Pusan, South Korea

Location

ENYO PHARMA Investigative site KR07

Pusan, South Korea

Location

ENYO PHARMA Investigative site KR05

Seongnam, South Korea

Location

ENYO PHARMA Investigative site KR01

Seoul, South Korea

Location

ENYO PHARMA Investigative site KR02

Seoul, South Korea

Location

ENYO PHARMA Investigative site KR03

Seoul, South Korea

Location

ENYO PHARMA Investigative site KR06

Seoul, South Korea

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

entecavir; Tenofovir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pietro Scalfaro
• Organization: ENYO Pharma SA

ps@enyopharma.com

+33437700219

Study Officials

• ENYO PHARMA Investigative site KR04

  Pusan, South Korea

  PRINCIPAL INVESTIGATOR

• ENYO PHARMA Investigative site KR03

  Seoul, South Korea

  PRINCIPAL INVESTIGATOR

• ENYO PHARMA Investigative site KR02

  Seoul, South Korea

  PRINCIPAL INVESTIGATOR

• ENYO PHARMA Investigative site KR01

  Seoul, 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Triple blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 10, 2020
• Study Start: May 12, 2020
• Primary Completion: June 17, 2021
• Study Completion: November 25, 2021
• Last Updated: November 2, 2022
• Results First Posted: October 12, 2022

Record last verified: 2022-10

Locations

AU (4); PL (6); HK (1); KR (7)