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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

Tracking Information
First Submitted Date  ICMJE April 23, 2020
First Posted Date  ICMJE April 28, 2020
Last Update Posted Date September 25, 2020
Actual Study Start Date  ICMJE May 25, 2020
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2020)
  • Number of Treatment-emergent adverse events [ Time Frame: 16 weeks ]
    Number of Treatment-emergent adverse events including serious adverse events
  • Measurement of HBsAg decline [ Time Frame: 16 weeks ]
    Measurement of HBsAg decline (Δ log10) from Day 1 to Week 16 of treatment period
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2020)
  • Measurement of HBsAg decline [ Time Frame: 40 weeks ]
    Measurement of HBsAg decline (Δ log10)
  • Measurement of HBV-DNA decline [ Time Frame: 40 weeks ]
    Measurement of HBV-DNA decline (Δ log10)
  • Measurement of HBV-pgRNA decline [ Time Frame: 40 weeks ]
    Measurement of HBV-pgRNA decline (Δ log10)
  • Measurement of HBcrAg decline [ Time Frame: 40 weeks ]
    Measurement of HBcrAg decline (Δ log10)
  • 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
  • Concentration of C4 - Pharmacodynamic biomarker [ Time Frame: 40 weeks ]
    Assessment of concentrations of plasma C4 (7α hydroxy 4 cholesten 3 one)
  • Concentration of FGF19 - Pharmacodynamic biomarker [ Time Frame: 40 weeks ]
    Assessment of concentrations of plasma FGF19 over time (Fibroblast Growth Factor 19)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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)
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis B, Chronic
Intervention  ICMJE
  • Drug: EYP001a
    Oral tablets
  • Drug: Entecavir
    Oral tablets
  • Drug: Pegylated interferon alpha2a
    Subcutaneous
Study Arms  ICMJE
  • Experimental: Arm 1
    EYP001a Dose A QD + ETV 0.5 mg QD + peg-IFN 180 µg QW
    Interventions:
    • Drug: EYP001a
    • Drug: Entecavir
    • Drug: Pegylated interferon alpha2a
  • Experimental: Arm 2
    EYP001a Dose A QD + peg-IFN 180 µg QW
    Interventions:
    • Drug: EYP001a
    • Drug: Pegylated interferon alpha2a
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 27, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Javiera Kaiser +61 3 9341 1900 Javiera.Kaiser@novotech-cro.com
Listed Location Countries  ICMJE Korea, Republic of,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04365933
Other Study ID Numbers  ICMJE EYP001-203
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Enyo Pharma
Study Sponsor  ICMJE Enyo Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Enyo Pharma
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP