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 | Completed Phase 2

• 1 other identifier: EYP001-203
• Study Type: interventional
• Target: 20
• Locations: 3 countries
• Sites: 6

Brief Summary

This is a multi centre, two parallel arm, randomized, open-label, Phase 2a experimental study of oral Farnesoid X Receptor (FXR) modulator EYP001a to assess its safety and anti-viral effect when administered to non-treated (treatment naive or off treatment) chronic Hepatitis B (CHB) patients in combination with entecavir (ETV) and pegylated interferon alpha2a (peg-IFN). An experimental treatment period of 16 weeks will be followed by a 24 week maintenance period with ETV standard of care (SoC).

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (2)

• Number of Treatment-emergent adverse events

  Number of Treatment-emergent adverse events including serious adverse events

  16 weeks

• Measurement of HBsAg decline

  Measurement of HBsAg decline (Δ log10) from Day 1 to Week 16 of treatment period

  16 weeks

Secondary Outcomes (8)

• Measurement of HBsAg decline

  40 weeks

• Measurement of HBV-DNA decline

  40 weeks

• Measurement of HBV-pgRNA decline

  40 weeks

• Measurement of HBcrAg decline

  40 weeks

• Concentration of EYP001a - Pharmacokinetic

  20 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL

EYP001a Dose A QD + ETV 0.5 mg QD + peg-IFN dosed per body surface area (180 µg, 135 µg or 90 µg) QW

Drug: EYP001a; Drug: Entecavir; Drug: Pegylated interferon alpha2a

Arm 2

EXPERIMENTAL

EYP001a Dose A QD + peg-IFN dosed per body surface area (180 µg, 135 µg or 90 µg) QW

Drug: EYP001a; Drug: Pegylated interferon alpha2a

Interventions

EYP001a DRUG

Oral tablets

Arm 1; Arm 2

Entecavir DRUG

Oral tablets

Arm 1

Pegylated interferon alpha2a DRUG

Subcutaneous

Arm 1; Arm 2

Eligibility Criteria

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

You may qualify if:

• Has given voluntary written informed consent before performance of any study related procedure.
• Are treatment naive or without HBV treatment for at least 60 days or 5 times the elimination half-life, whichever is longer.
• Patient has CHB:
• HBV DNA ≥ 20,000 IU/mL for HBeAg positive and ≥2'000 for HBeAg negative and
• HBsAg ≥ 2.5 log10 IU/mL.
• Has liver imaging to screen for hepatocellular carcinoma or concomitant pancreaticobiliary disease either in the prior 6 months or at screening.
• Patient 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 clinical research organization, vendor, or Sponsor involved with this study.
• Has known hepatocellular carcinoma or pancreaticobiliary disease.
• Neutropenia (defined by two confirmed values during Screening period of \< 1500/μL).
• Has Gilbert syndrome.
• Shows evidence of worsening liver tests, defined as either a confirmed (2 assessments at least 3 days apart) increase \> 2 ULN ALT or AST or an increase of \> 1.5 × baseline 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.
• Has known history of alcohol abuse or daily heavy alcohol consumption
• ALT \> 2 × ULN, AST \> 2 × ULN
• INR \> 1.2 × ULN, (normal range is 0.8 to 1.2)
• Platelet count \< 100 G/L
• Estimated glomerular filtration rate \< 50 mL/min/1.73m2 (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

Study Sites (6)

ENYO PHARMA Investigative site HK01

Hong Kong, Hong Kong

Location

ENYO PHARMA Investigative site KR01

Busan, South Korea

Location

ENYO PHARMA Investigative site TW03

Kaohsiung City, Taiwan

Location

ENYO PHARMA Investigative site TW04

Kaohsiung City, Taiwan

Location

ENYO PHARMA Investigative site TW01

Taipei, Taiwan

Location

ENYO PHARMA Investigative site TW02

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

entecavir; peginterferon alfa-2a

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 28, 2020
• Study Start: May 25, 2020
• Primary Completion: June 16, 2021
• Study Completion: November 29, 2021
• Last Updated: August 25, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1); TW (4); KR (1)