Hepatitis B, ChronicPhase 2NCT04365933
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
A Phase 2 study testing EYP001a, Entecavir and Pegylated interferon alpha2a in people with Hepatitis B, Chronic, run by Enyo Pharma at 6 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- EYP001a, Entecavir and Pegylated interferon alpha2a
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 25 May 2020to 29 Nov 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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:
- 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.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Taiwan4 sites
ENYO PHARMA Investigative site TW03
Kaohsiung City
ENYO PHARMA Investigative site TW04
Kaohsiung City
ENYO PHARMA Investigative site TW01
Taipei
ENYO PHARMA Investigative site TW02
Taoyuan
About this study
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)
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).
Read the 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
- Being tested
- EYP001a, Entecavir, Pegylated interferon alpha2a
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EYP001aDrug
Oral tablets
EntecavirDrug
Oral tablets
Pegylated interferon alpha2aDrug
Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: EYP001a; Drug: Pegylated interferon alpha2a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment-emergent adverse events
Number of Treatment-emergent adverse events including serious adverse events
Measured: 16 weeks
Measurement of HBsAg decline
Measurement of HBsAg decline (Δ log10) from Day 1 to Week 16 of treatment period
Measured: 16 weeks
Secondary outcomes (8)
Measurement of HBsAg decline
Measurement of HBsAg decline (Δ log10)
Measured: 40 weeks
Measurement of HBV-DNA decline
Measurement of HBV-DNA decline (Δ log10)
Measured: 40 weeks
Measurement of HBV-pgRNA decline
Measurement of HBV-pgRNA decline (Δ log10)
Measured: 40 weeks
Measurement of HBcrAg decline
Measurement of HBcrAg decline (Δ log10)
Measured: 40 weeks
Concentration of EYP001a - Pharmacokinetic
Assessment of fasted plasma concentrations of EYP001a or any active metabolites using a validated liquid chromatography-mass spectrometry
Measured: 20 weeks
Concentration of C4 - Pharmacodynamic biomarker
Assessment of concentrations of plasma C4 (7α hydroxy 4 cholesten 3 one)
Measured: 40 weeks
Concentration of FGF19 - Pharmacodynamic biomarker
Assessment of concentrations of plasma FGF19 over time (Fibroblast Growth Factor 19)
Measured: 40 weeks
Concentration of Bile Acids - Pharmacodynamic biomarker
Assessment of concentrations over time of plasma Bile Acids (chenodeoxycholic acid, deoxycholic acid, lithocholic acid)
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start25 May 2020
- Primary completion16 Jun 2021
- Study completion29 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enyo Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365933
- Sponsor's protocol ID
- EYP001-203
- Status last verified
- Aug 2022
- First submitted
- 23 Apr 2020
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04365933
- Acronym / sponsor ID
- EYP001-203
- Conditions
- Hepatitis B, Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Enyo PharmaIndustry (pharma, biotech, devices)
- Study start
- 25 May 2020 (actual)
- Primary completion
- 16 Jun 2021 (actual)
- Study completion
- 29 Nov 2021 (actual)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: EYP001a, Drug: Entecavir, Drug: Pegylated interferon alpha2aEYP001a Dose A QD + ETV 0.5 mg QD + peg-IFN dosed per body surface area (180 µg, 135 µg or 90 µg) QW |
| Arm 2 | Experimental | Drug: EYP001a, Drug: Pegylated interferon alpha2aEYP001a Dose A QD + peg-IFN dosed per body surface area (180 µg, 135 µg or 90 µg) QW |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EYP001aOral tablets | Drug | Arm 1, Arm 2 |
| EntecavirOral tablets | Drug | Arm 1 |
| Pegylated interferon alpha2aSubcutaneous | Drug | Arm 1, Arm 2 |
Primary outcome
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
8 secondary outcomes
Measurement of HBsAg decline
Time frame: 40 weeks
Measurement of HBV-DNA decline
Time frame: 40 weeks
Measurement of HBV-pgRNA decline
Time frame: 40 weeks
Measurement of HBcrAg decline
Time frame: 40 weeks
Concentration of EYP001a - Pharmacokinetic
Time frame: 20 weeks
Concentration of C4 - Pharmacodynamic biomarker
Time frame: 40 weeks
Concentration of FGF19 - Pharmacodynamic biomarker
Time frame: 40 weeks
Concentration of Bile Acids - Pharmacodynamic biomarker
Time frame: 40 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EYP001a, Entecavir and Pegylated interferon alpha2a in people with Hepatitis B, Chronic, run by Enyo Pharma at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Taiwan, Hong Kong, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Treatment-emergent adverse events (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.