Hepatitis B, ChronicPhase 2NCT04465916
Study of EYP001a to Assess Its Safety and Anti-viral Effect in CHB Patients in Combination With NA (ETV or TD)
A Phase 2 study testing EYP001a and Nucleotide analogue (Entecavir or Tenofovir Disoproxil) in people with Hepatitis B, Chronic, run by Enyo Pharma at 18 sites in 4 countries.
Trial summary
This is a prospective, multi-centre, randomized, double-blind, placebo-controlled, Phase 2a experimental study of oral FXR modulator EYP001a/placebo combined with NAs in virologically suppressed CHB patients to improve functional cure rates. 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 and Nucleotide analogue (Entecavir or Tenofovir Disoproxil)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 18 sitesin 4 countries
- Study dates
- 12 May 2020to 25 Nov 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Main Inclusion Criteria:
- Are on stable NA therapy at least 12 months from the screening date (ETV or TDF)
- Has virally suppressed CHB:
HBV DNA <LLOQ and serum HBsAg >100 IU/mL
- Has liver imaging to screen for hepatocellular carcinoma or concomitant pancreaticobiliary disease either in the prior 6 months or at screening.
- 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.
Main Exclusion Criteria:
- Is an employee of a contract research organization (CRO), vendor, or Sponsor involved with this study.
- Has known hepatocellular carcinoma or pancreaticobiliary disease.
- Neutropenia (defined by two confirmed values within screening period of <1500/μL).
- Has Gilbert syndrome.
- Shows evidence of worsening liver function, defined as either a confirmed (two assessments at least 3 days apart) increase >2 ULN ALT or AST or an increase of >1.5 × first assessed 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 F3 stage with a vibration controlled transient elastography (VCTE). Patients with normal baseline ALT and VCTE >8.8 kPa are excluded. Patients with baseline ALT >ULN (but <2ULN per EC5) and who have VCTE >10.5 kPa at baseline are excluded 11.
- Has known history of alcohol abuse or daily heavy alcohol consumption
- Has clinically relevant immunosuppression, including, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia.
- Has used anti-HBV medications other than NAs within 90 days prior to screening.
- Has any of the following exclusionary laboratory results at screening:
- Estimated glomerular filtration rate <60 mL/min/1.73 m2 (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
18 sites in 4 countries.
18 sites in 4 countries
South Korea7 sites
ENYO PHARMA Investigative site KR04
Pusan
ENYO PHARMA Investigative site KR07
Pusan
ENYO PHARMA Investigative site KR05
Seongnam
ENYO PHARMA Investigative site KR01
Seoul
ENYO PHARMA Investigative site KR02
Seoul
ENYO PHARMA Investigative site KR03
Seoul
ENYO PHARMA Investigative site KR06
Seoul
Poland6 sites
ENYO PHARMA Investigative site PL01
Bialystok
ENYO PHARMA Investigative site PL06
Kielce
ENYO PHARMA Investigative site PL05
Lodz
ENYO PHARMA Investigative site PL02
Lublin
ENYO PHARMA Investigative site PL03
Warsaw
ENYO PHARMA Investigative site PL04
Zawiercie
Australia4 sites
ENYO PHARMA Investigative site AU02
Brisbane
ENYO PHARMA Investigative site AU01
Melbourne
ENYO PHARMA Investigative site AU03
Melbourne
ENYO PHARMA Investigative site AU04
Melbourne
About this study
Official title: A Phase 2a, Randomized, Double-blind, Placebo-controlled Study of Oral FXR Modulator EYP001a Combined With Nucleos(t)Ide Analogues (NA) in Virologically Suppressed Chronic Hepatitis B Patients to Improve Functional Cure Rates
This is a prospective, multi-centre, randomized, double-blind, placebo-controlled, Phase 2a experimental study of oral FXR modulator EYP001a/placebo combined with NAs in virologically suppressed CHB patients to improve functional cure rates.
Read the detailed description
A total of 49 eligible patients will be enrolled and randomized at approximately 14 study sites. Patients will be randomized prior to study drug (EYP001a or placebo and NA) administration on Day 1 in the ratio of 3:1 into 2 arms:
- Experimental Arm: EYP001a Dose A QD + NA daily (37 patients)
- Control Arm: Placebo + NA daily (12 patients)
The maximum total engagement duration for eligible patients in this study is up to 370 days: 90 days screening, 112 days (16 weeks) treatment period and 168 days (24 weeks) follow-up.
Patients enrolled in the study will be assessed as outpatients. Patient screening will occur no more than 90 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: 12 weeks (90 days)
- 16 weeks treatment period:
- Treatment Visit 1 (Week 1 [Day 1])
- Treatment Visit 2 (Week 2 [Day 14 ±3 days])
- Treatment Visit 3 (Week 4 [Day 28 ±3 days])
- Treatment Visit 4 (Week 6 [Day 42 ±3 days])
- Treatment Visit 5 (Week 8 [Day 56 ±3 days])
- Treatment Visit 6 (Week 10 [Day 70 ± 3 days])
- Treatment Visit 7 (Week 12 [Day 84 ± 3 days])
- Treatment Visit 8 (Week 14 [Day 98 ± 3 days])
- Treatment Visit 9 (Week 16 [Day 112±3 days])
- 24 weeks safety follow-up period:
- Follow-up Visit 1 (Week 20 [Day 140 ±7 days])
- Follow-up Visit 2 (Week 28 [Day 196 ±7 days])
- Follow-up Visit 3 (Week 40 [Day 280 ±7 days]) Note: during follow-up patients are kept on NA until the end of the trial: Week 40 (consolidation Phase).
- Conditions
- Hepatitis B, Chronic
- Being tested
- EYP001a, Placebo, Nucleotide analogue (Entecavir or Tenofovir Disoproxil)
- 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
PlaceboDrug
Oral tablets
Nucleotide analogue (Entecavir or Tenofovir Disoproxil)Drug
Oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Experimental Arm: EYP001a Dose A QD + NA daily (37 patients) Receives: Drug: EYP001a; Drug: Nucleotide analogue (Entecavir or Tenofovir Disoproxil) |
| Control Arm | Placebo comparator | Control Arm: Placebo + NA daily (12 patients) Receives: Drug: Placebo; Drug: Nucleotide analogue (Entecavir or Tenofovir Disoproxil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBsAg Change (Δ log10) From Day 1 to Week 16 of Treatment
Efficacy of Vonafexor on top of NA assessed as HBsAg decline (Δ log10) from Day 1 to Week 16 of treatment
Measured: LS mean at week 16 (Day 1, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, and Week 16)
Secondary outcomes (1)
Virologic Failure Rate
Virologic failure rate (breakthrough)2 of HBV-DNA (% patients with a confirmed quantifiable HBV DNA increase of ≥ 1log10 HBV DNA copies/mL above LLOQ3) assessed at Week 16 of treatment period and Weeks 20, 28 and 40 during follow-up period
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 posted10 Jul 2020
- Study start12 May 2020
- Primary completion17 Jun 2021
- Study completion25 Nov 2021
Why it stopped: DSMC reviewed results of 26 subjects. New randomizations were stopped. Already randomized subjects were followed up to W40.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enyo Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited, Synteract, Inc., Eurofins, Parexel
- Responsible party
- Sponsor
- Investigators
- ENYO PHARMA Investigative site KR04, Principal investigator, Pusan, South KoreaENYO PHARMA Investigative site KR03, Principal investigator, Seoul, South KoreaENYO PHARMA Investigative site KR02, Principal investigator, Seoul, South KoreaENYO PHARMA Investigative site KR01, Principal investigator, Seoul, South KoreaENYO PHARMA Investigative site PL06, Principal investigator, Kielce, PolandENYO PHARMA Investigative site PL05, Principal investigator, Łódź, PolandENYO PHARMA Investigative site PL04, Principal investigator, Zawiercie, PolandENYO PHARMA Investigative site PL03, Principal investigator, Warszawa, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465916
- Sponsor's protocol ID
- EYP001-201
- Status last verified
- Oct 2022
- First submitted
- 6 Jul 2020
- Last updated
- 2 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-blind, Placebo-controlled Study of Oral FXR Modulator EYP001a Combined With Nucleos(t)Ide Analogues (NA) in Virologically Suppressed Chronic Hepatitis B Patients to Improve Functional Cure Rates
- ClinicalTrials.gov ID
- NCT04465916
- Acronym / sponsor ID
- EYP001-201
- Conditions
- Hepatitis B, Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DSMC reviewed results of 26 subjects. New randomizations were stopped. Already randomized subjects were followed up to W40.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Enyo PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited, Synteract, Inc., Eurofins, Parexel
- Study start
- 12 May 2020 (actual)
- Primary completion
- 17 Jun 2021 (actual)
- Study completion
- 25 Nov 2021 (actual)
- First posted
- 10 Jul 2020 (actual)
- Results
- Posted 12 Oct 2022
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 prospective, multi-centre, randomized, double-blind, placebo-controlled, Phase 2a experimental study of oral FXR modulator EYP001a/placebo combined with NAs in virologically suppressed CHB patients to improve functional cure rates.
Detailed description
A total of 49 eligible patients will be enrolled and randomized at approximately 14 study sites. Patients will be randomized prior to study drug (EYP001a or placebo and NA) administration on Day 1 in the ratio of 3:1 into 2 arms:
- Experimental Arm: EYP001a Dose A QD + NA daily (37 patients)
- Control Arm: Placebo + NA daily (12 patients)
The maximum total engagement duration for eligible patients in this study is up to 370 days: 90 days screening, 112 days (16 weeks) treatment period and 168 days (24 weeks) follow-up.
Patients enrolled in the study will be assessed as outpatients. Patient screening will occur no more than 90 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: 12 weeks (90 days)
- 16 weeks treatment period:
- Treatment Visit 1 (Week 1 [Day 1])
- Treatment Visit 2 (Week 2 [Day 14 ±3 days])
- Treatment Visit 3 (Week 4 [Day 28 ±3 days])
- Treatment Visit 4 (Week 6 [Day 42 ±3 days])
- Treatment Visit 5 (Week 8 [Day 56 ±3 days])
- Treatment Visit 6 (Week 10 [Day 70 ± 3 days])
- Treatment Visit 7 (Week 12 [Day 84 ± 3 days])
- Treatment Visit 8 (Week 14 [Day 98 ± 3 days])
- Treatment Visit 9 (Week 16 [Day 112±3 days])
- 24 weeks safety follow-up period:
- Follow-up Visit 1 (Week 20 [Day 140 ±7 days])
- Follow-up Visit 2 (Week 28 [Day 196 ±7 days])
- Follow-up Visit 3 (Week 40 [Day 280 ±7 days]) Note: during follow-up patients are kept on NA until the end of the trial: Week 40 (consolidation Phase).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: EYP001a, Drug: Nucleotide analogue (Entecavir or Tenofovir Disoproxil)Experimental Arm: EYP001a Dose A QD + NA daily (37 patients) |
| Control Arm | Placebo comparator | Drug: Placebo, Drug: Nucleotide analogue (Entecavir or Tenofovir Disoproxil)Control Arm: Placebo + NA daily (12 patients) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 | Experimental Arm |
| PlaceboOral tablets | Drug | Control Arm |
| Nucleotide analogue (Entecavir or Tenofovir Disoproxil)Oral tablets | Drug | Control Arm, Experimental Arm |
Primary outcome
HBsAg Change (Δ log10) From Day 1 to Week 16 of Treatment
Time frame: LS mean at week 16 (Day 1, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, and Week 16)
Efficacy of Vonafexor on top of NA assessed as HBsAg decline (Δ log10) from Day 1 to Week 16 of treatment
1 secondary outcome
Virologic Failure Rate
Time frame: 40 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
ENYO PHARMA Investigative site KR04 principal investigator
Pusan, South Korea
ENYO PHARMA Investigative site KR03 principal investigator
Seoul, South Korea
ENYO PHARMA Investigative site KR02 principal investigator
Seoul, South Korea
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EYP001a and Nucleotide analogue (Entecavir or Tenofovir Disoproxil) in people with Hepatitis B, Chronic, run by Enyo Pharma at 18 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in South Korea, Poland, Australia, Hong Kong. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 12 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
HBsAg Change (Δ log10) From Day 1 to Week 16 of Treatment (time frame: LS mean at week 16 (Day 1, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, and Week 16)). 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 2 Nov 2022.