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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

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ClinicalTrials.gov Identifier: NCT04365933
Recruitment Status : Recruiting
First Posted : April 28, 2020
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
Enyo Pharma

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).

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: EYP001a Drug: Entecavir Drug: Pegylated interferon alpha2a Phase 2

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 180 µg QW (± 3 days) (15 patients)
  • Arm 2: EYP001a QD + peg-IFN 180 µg QW (± 3 days) (15 patients)

Patients enrolled in the study will be assessed as outpatients. Patient screening will occur no more than 30 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: 4 weeks (30 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2a Open-label Study of the Oral Farnesoid X Receptor (FXR) Modulator EYP001a to Assess Its Safety and Anti-viral Effect in Chronic Hepatitis B (CHB) Patients in Combination With Pegylated Interferon alpha2a (Peg-IFN) Alone and With Entecavir (ETV)
Actual Study Start Date : May 25, 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : July 2021


Arm Intervention/treatment
Experimental: Arm 1
EYP001a Dose A QD + ETV 0.5 mg QD + peg-IFN 180 µg QW
Drug: EYP001a
Oral tablets

Drug: Entecavir
Oral tablets

Drug: Pegylated interferon alpha2a
Subcutaneous

Experimental: Arm 2
EYP001a Dose A QD + peg-IFN 180 µg QW
Drug: EYP001a
Oral tablets

Drug: Pegylated interferon alpha2a
Subcutaneous




Primary Outcome Measures :
  1. Number of Treatment-emergent adverse events [ Time Frame: 16 weeks ]
    Number of Treatment-emergent adverse events including serious adverse events

  2. Measurement of HBsAg decline [ Time Frame: 16 weeks ]
    Measurement of HBsAg decline (Δ log10) from Day 1 to Week 16 of treatment period


Secondary Outcome Measures :
  1. Measurement of HBsAg decline [ Time Frame: 40 weeks ]
    Measurement of HBsAg decline (Δ log10)

  2. Measurement of HBV-DNA decline [ Time Frame: 40 weeks ]
    Measurement of HBV-DNA decline (Δ log10)

  3. Measurement of HBV-pgRNA decline [ Time Frame: 40 weeks ]
    Measurement of HBV-pgRNA decline (Δ log10)

  4. Measurement of HBcrAg decline [ Time Frame: 40 weeks ]
    Measurement of HBcrAg decline (Δ log10)

  5. Concentration of EYP001a - Pharmacokinetic [ Time Frame: 20 weeks ]
    Assessment of fasted plasma concentrations of EYP001a or any active metabolites using a validated liquid chromatography-mass spectrometry

  6. Concentration of C4 - Pharmacodynamic biomarker [ Time Frame: 40 weeks ]
    Assessment of concentrations of plasma C4 (7α hydroxy 4 cholesten 3 one)

  7. Concentration of FGF19 - Pharmacodynamic biomarker [ Time Frame: 40 weeks ]
    Assessment of concentrations of plasma FGF19 over time (Fibroblast Growth Factor 19)

  8. Concentration of Bile Acids - Pharmacodynamic biomarker [ Time Frame: 40 weeks ]
    Assessment of concentrations over time of plasma Bile Acids (chenodeoxycholic acid, deoxycholic acid, lithocholic acid)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 < 60 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04365933


Contacts
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Contact: Javiera Kaiser +61 3 9341 1900 Javiera.Kaiser@novotech-cro.com

Locations
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Korea, Republic of
ENYO PHARMA Investigative site KR01 Not yet recruiting
Busan, Korea, Republic of
Contact: Javiera Kaiser         
ENYO PHARMA Investigative site KR02 Not yet recruiting
Seoul, Korea, Republic of
Contact: Javiera Kaiser         
ENYO PHARMA Investigative site KR03 Not yet recruiting
Seoul, Korea, Republic of
Contact: Javiera Kaiser         
Taiwan
ENYO PHARMA Investigative site TW03 Recruiting
Kaohsiung, Taiwan
Contact: Javiera Kaiser         
ENYO PHARMA Investigative site TW04 Recruiting
Kaohsiung, Taiwan
Contact: Javiera Kaiser         
ENYO PHARMA Investigative site TW01 Recruiting
Taipei, Taiwan
Contact: Javiera Kaiser         
ENYO PHARMA Investigative site TW02 Recruiting
Taoyuan, Taiwan
Contact: Javiera Kaiser         
Sponsors and Collaborators
Enyo Pharma
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Responsible Party: Enyo Pharma
ClinicalTrials.gov Identifier: NCT04365933    
Other Study ID Numbers: EYP001-203
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Interferons
Interferon-alpha
Interferon alpha-2
Entecavir
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs