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

NCT ID: NCT04365933

Last Updated: 2022-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-25
• Study Completion Date: 2021-11-29

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).

Detailed Description

In total 30 eligible patients will be enrolled and randomized at approximately 7 study sites.

Patients will be randomized prior to study drug (EYP001a, ETV and peg-IFN) administration on Day 1 in the ratio of 1:1 into 2 treatment arms:

• Arm 1: EYP001a QD + ETV 0.5 mg QD + peg-IFN dosed per body surface area (180 µg, 135 µg or 90 µg) QW (± 3 days) (15 patients)
• Arm 2: EYP001a QD + peg-IFN dosed per body surface area (180 µg, 135 µg or 90 µg) QW (± 3 days) (15 patients)

Patients enrolled in the study will be assessed as outpatients. Patient screening will occur no more than 37 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: 5 weeks (37 days)
• 16 weeks treatment period
• 24 weeks maintenance period. During maintenance period patients are kept on ETV until the end of the trial at Week 40.

Conditions

Hepatitis B, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

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

Group Type: EXPERIMENTAL

EYP001a

Intervention Type: DRUG

Oral tablets

Entecavir

Intervention Type: DRUG

Oral tablets

Pegylated interferon alpha2a

Intervention Type: DRUG

Subcutaneous

Arm 2

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

Group Type: EXPERIMENTAL

EYP001a

Intervention Type: DRUG

Oral tablets

Pegylated interferon alpha2a

Intervention Type: DRUG

Subcutaneous

Interventions

EYP001a

Oral tablets

Intervention Type: DRUG

Entecavir

Oral tablets

Intervention Type: DRUG

Pegylated interferon alpha2a

Subcutaneous

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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:

1. HBV DNA ≥ 20,000 IU/mL for HBeAg positive and ≥2'000 for HBeAg negative and

2. 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.

Exclusion Criteria

• 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.
• Probable or possible F4 stage with a vibration controlled transient elastography (VCTE) > 11.7 kPa leads to exclusion
• Has known history of alcohol abuse or daily heavy alcohol consumption
• Has any of the following exclusionary laboratory results at screening:

1. ALT > 2 × ULN, AST > 2 × ULN

2. INR > 1.2 × ULN, (normal range is 0.8 to 1.2)

3. Platelet count < 100 G/L

4. Estimated glomerular filtration rate < 50 mL/min/1.73m2 (the Modification of Diet in Renal Disease formula)

5. Thyroid-stimulating hormone > 1.5 × ULN or abnormal free triiodothyronine or free thyroxine.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Enyo Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ENYO PHARMA Investigative site HK01

Hong Kong, , Hong Kong

ENYO PHARMA Investigative site KR01

Busan, , South Korea

ENYO PHARMA Investigative site TW03

Kaohsiung City, , Taiwan

ENYO PHARMA Investigative site TW04

Kaohsiung City, , Taiwan

ENYO PHARMA Investigative site TW01

Taipei, , Taiwan

ENYO PHARMA Investigative site TW02

Taoyuan District, , Taiwan

Countries

Hong Kong; South Korea; Taiwan

Other Identifiers

EYP001-203

Identifier Type: -

Identifier Source: org_study_id