NCT04470388

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2020

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 9, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

12 months

First QC Date

July 10, 2020

Last Update Submit

January 6, 2022

Conditions

Chronic HBV Infection

Keywords

Multiple Ascending Dosehepatitis B virusHBV

Outcome Measures

Primary Outcomes (1)

  • Safety measured by adverse events

    Up to 84 Days in HBV MAD Cohorts

Secondary Outcomes (3)

  • Cmax of EDP-514

    Up to 28 Days in HBV MAD Cohorts

  • AUC of EDP-514

    Up to 28 Days in HBV MAD Cohorts

  • Change from baseline in HBV DNA Viral Load Assay

    through Day 28 in HBV MAD Cohorts

Study Arms (2)

EDP-514 HBV MAD Cohorts

EXPERIMENTAL

EDP-514 capsule Dose 1, Dose 2 and Dose 3 orally, once daily for 28 days.

Drug: EDP-514

EDP-514 HBV MAD Placebo Cohort

PLACEBO COMPARATOR

Matching placebo, orally, once daily for 28 days.

Drug: Placebo

Interventions

EDP-514DRUG

Oral Capsule

EDP-514 HBV MAD Cohorts
PlaceboDRUG

Placebo to match EDP-514

EDP-514 HBV MAD Placebo Cohort

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Chia-Yi Christian Hospital

Chiayi City, Chiayi, 600566, Taiwan

Location

Changhua Christian Hospital

Changhua, 500209, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 500209, Taiwan

Location

E-Da Hospital/E-DA Cancer Hospital

Kaohsiung City, 824410, Taiwan

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833401, Taiwan

Location

China Medical University Hospital

Taichung, 404332, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704302, Taiwan

Location

National Taiwan University Hospital

Taipei, 100229, Taiwan

Location

Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch

Taoyuan District, 333423, Taiwan

Location

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Enanta Pharmaceuticals, Inc

    Enanta Pharmaceuticals, Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2020

First Posted

July 14, 2020

Study Start

September 9, 2020

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

January 11, 2022

Record last verified: 2022-01

Locations

HK(1)TW(9)