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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04365933
Other study ID # EYP001-203
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 25, 2020
Est. completion date November 29, 2021

Study information

Verified date August 2022
Source Enyo Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date November 29, 2021
Est. primary completion date June 16, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
EYP001a
Oral tablets
Entecavir
Oral tablets
Pegylated interferon alpha2a
Subcutaneous

Locations

Country Name City State
Hong Kong ENYO PHARMA Investigative site HK01 Hong Kong
Korea, Republic of ENYO PHARMA Investigative site KR01 Busan
Taiwan ENYO PHARMA Investigative site TW03 Kaohsiung
Taiwan ENYO PHARMA Investigative site TW04 Kaohsiung
Taiwan ENYO PHARMA Investigative site TW01 Taipei
Taiwan ENYO PHARMA Investigative site TW02 Taoyuan

Sponsors (1)

Lead Sponsor Collaborator
Enyo Pharma

Countries where clinical trial is conducted

Hong Kong,  Korea, Republic of,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Treatment-emergent adverse events Number of Treatment-emergent adverse events including serious adverse events 16 weeks
Primary Measurement of HBsAg decline Measurement of HBsAg decline (? log10) from Day 1 to Week 16 of treatment period 16 weeks
Secondary Measurement of HBsAg decline Measurement of HBsAg decline (? log10) 40 weeks
Secondary Measurement of HBV-DNA decline Measurement of HBV-DNA decline (? log10) 40 weeks
Secondary Measurement of HBV-pgRNA decline Measurement of HBV-pgRNA decline (? log10) 40 weeks
Secondary Measurement of HBcrAg decline Measurement of HBcrAg decline (? log10) 40 weeks
Secondary Concentration of EYP001a - Pharmacokinetic Assessment of fasted plasma concentrations of EYP001a or any active metabolites using a validated liquid chromatography-mass spectrometry 20 weeks
Secondary Concentration of C4 - Pharmacodynamic biomarker Assessment of concentrations of plasma C4 (7a hydroxy 4 cholesten 3 one) 40 weeks
Secondary Concentration of FGF19 - Pharmacodynamic biomarker Assessment of concentrations of plasma FGF19 over time (Fibroblast Growth Factor 19) 40 weeks
Secondary Concentration of Bile Acids - Pharmacodynamic biomarker Assessment of concentrations over time of plasma Bile Acids (chenodeoxycholic acid, deoxycholic acid, lithocholic acid) 40 weeks
See also
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Enrolling by invitation NCT04160897 - Risk of Hepatocellular Carcinoma in Patients Treated With ETV vs TDF for Chronic Hepatitis B With Compensated Cirrhosis
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