Chronic HBV InfectionPhase 1NCT04470388
A Study of EDP-514 in Patients With Chronic Hepatitis B Virus Infection Who Are Not Currently on Treatment
A Phase 1 study testing EDP-514 in people with Chronic HBV Infection, run by Enanta Pharmaceuticals, Inc at 10 sites in 2 countries.
Trial summary
This is a randomized, double-blind, placebo-controlled study in viremic chronic hepatitis B subjects, assessing the safety, tolerability, pharmacokinetics and antiviral activity of 28 Days treatment with EDP-514. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic HBV Infection
- What is being tested?
- EDP-514
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 9 Sep 2020to 30 Aug 2021
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An informed consent document signed and dated by the subject.
- Healthy male and female subjects of any ethnic origin between the ages of 18 and 70 years, inclusive
- HBV DNA levels:
- For subjects who are HBeAg positive at Screening, a Screening HBV DNA level in serum/plasma that is ≥20,000 IU/ml, or
- For subjects who are HBeAg negative at Screening, a Screening HBV DNA level in serum/plasma that is ≥2,000 IU/mL, and
- For all subjects, no HBV DNA serum/plasma test values <1,000 IU/ml over the previous 12 months (using an approved test)
- CHB subjects must not have been on prescribed anti-HBV treatment for at least 12 months prior to Screening
Who cannot join
- A documented prior diagnosis of cirrhosis
- Pregnant or nursing females
- Coinfection with human immunodeficiency virus (HIV), HCV, HDV, HAV, or HEV
- Chronic liver disease of a non-HBV etiology; coexisting liver or biliary diseases
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Taiwan9 sites
Changhua Christian Hospital
Changhua, 500209
Chia-Yi Christian Hospital
Chiayi City, Chiayi, 600566
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 500209
E-Da Hospital/E-DA Cancer Hospital
Kaohsiung City, 824410
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833401
China Medical University Hospital
Taichung, 404332
National Cheng Kung University Hospital
Tainan, 704302
National Taiwan University Hospital
Taipei, 100229
Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch
Taoyuan, 333423
About this study
Official title: A Phase 1b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of EDP 514 in Viremic Chronic Hepatitis B Virus Infected Patients Not Currently on Treatment
This is a randomized, double-blind, placebo-controlled study in viremic chronic hepatitis B subjects, assessing the safety, tolerability, pharmacokinetics and antiviral activity of 28 Days treatment with EDP-514.
Read the detailed description
The study assesses multiple ascending doses of EDP-514 compared to placebo for 28 days in viremic chronic CHB-infected subjects not currently on treatment.
Each cohort will enroll a total of 8 subjects who will be randomized to receive EDP-514 or placebo.
- Conditions
- Chronic HBV Infection
- Being tested
- EDP-514, Placebo
- Keywords
- Multiple Ascending Dose, hepatitis B virus, HBV
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDP-514Drug
Oral Capsule
PlaceboDrug
Placebo to match EDP-514
| Study group | Role | What they receive |
|---|---|---|
| EDP-514 HBV MAD Cohorts | Experimental | EDP-514 capsule Dose 1, Dose 2 and Dose 3 orally, once daily for 28 days. Receives: Drug: EDP-514 |
| EDP-514 HBV MAD Placebo Cohort | Placebo comparator | Matching placebo, orally, once daily for 28 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measured by adverse events
Measured: Up to 84 Days in HBV MAD Cohorts
Secondary outcomes (3)
Cmax of EDP-514
Measured: Up to 28 Days in HBV MAD Cohorts
AUC of EDP-514
Measured: Up to 28 Days in HBV MAD Cohorts
Change from baseline in HBV DNA Viral Load Assay
Measured: through Day 28 in HBV MAD Cohorts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start9 Sep 2020
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic HBV InfectionStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enanta Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharmaceutical Research Associates
- Responsible party
- Sponsor
- Investigators
- Enanta Pharmaceuticals, Inc, Study director, Enanta Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470388
- Sponsor's protocol ID
- EDP 514-002
- Status last verified
- Jan 2022
- First submitted
- 10 Jul 2020
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of EDP 514 in Viremic Chronic Hepatitis B Virus Infected Patients Not Currently on Treatment
- ClinicalTrials.gov ID
- NCT04470388
- Acronym / sponsor ID
- EDP 514-002
- Conditions
- Chronic HBV Infection
- Keywords
- Multiple Ascending Dose, hepatitis B virus, HBV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Enanta Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Collaborators
- Pharmaceutical Research Associates
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 14 Jul 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 randomized, double-blind, placebo-controlled study in viremic chronic hepatitis B subjects, assessing the safety, tolerability, pharmacokinetics and antiviral activity of 28 Days treatment with EDP-514.
Detailed description
The study assesses multiple ascending doses of EDP-514 compared to placebo for 28 days in viremic chronic CHB-infected subjects not currently on treatment.
Each cohort will enroll a total of 8 subjects who will be randomized to receive EDP-514 or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EDP-514 HBV MAD Cohorts | Experimental | Drug: EDP-514EDP-514 capsule Dose 1, Dose 2 and Dose 3 orally, once daily for 28 days. |
| EDP-514 HBV MAD Placebo Cohort | Placebo comparator | Drug: PlaceboMatching placebo, orally, once daily for 28 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- An informed consent document signed and dated by the subject.
- Healthy male and female subjects of any ethnic origin between the ages of 18 and 70 years, inclusive
- HBV DNA levels:
- CHB subjects must not have been on prescribed anti-HBV treatment for at least 12 months prior to Screening
Key exclusion criteria (4 listed)
- A documented prior diagnosis of cirrhosis
- Pregnant or nursing females
- Coinfection with human immunodeficiency virus (HIV), HCV, HDV, HAV, or HEV
- Chronic liver disease of a non-HBV etiology; coexisting liver or biliary diseases
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 |
|---|---|---|
| EDP-514Oral Capsule | Drug | EDP-514 HBV MAD Cohorts |
| PlaceboPlacebo to match EDP-514 | Drug | EDP-514 HBV MAD Placebo Cohort |
Primary outcome
Safety measured by adverse events
Time frame: Up to 84 Days in HBV MAD Cohorts
3 secondary outcomes
Cmax of EDP-514
Time frame: Up to 28 Days in HBV MAD Cohorts
AUC of EDP-514
Time frame: Up to 28 Days in HBV MAD Cohorts
Change from baseline in HBV DNA Viral Load Assay
Time frame: through Day 28 in HBV MAD Cohorts
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 11 Jan 2022.
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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.
Enanta Pharmaceuticals, Inc study director
Enanta Pharmaceuticals, Inc
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EDP-514 in people with Chronic HBV Infection, run by Enanta Pharmaceuticals, Inc at 10 sites in 2 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 4 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 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Taiwan, 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety measured by adverse events (time frame: Up to 84 Days in HBV MAD Cohorts). 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 11 Jan 2022.