Back to resultsA Study of EDP-514 in Patients With Chronic Hepatitis B Virus Infection Who Are Not Currently on Treatment
Primary Purpose
Chronic HBV Infection
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
EDP-514
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic HBV Infection focused on measuring Multiple Ascending Dose, hepatitis B virus, HBV
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Queen Mary Hospital
- Changhua Christian Hospital
- Chia-Yi Christian Hospital
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- E-Da Hospital/E-DA Cancer Hospital
- Kaohsiung Chang Gung Memorial Hospital
- China Medical University Hospital
- National Cheng Kung University Hospital
- National Taiwan University Hospital
- Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
EDP-514 HBV MAD Cohorts
EDP-514 HBV MAD Placebo Cohort
Arm Description
EDP-514 capsule Dose 1, Dose 2 and Dose 3 orally, once daily for 28 days.
Matching placebo, orally, once daily for 28 days.
Outcomes
Primary Outcome Measures
Safety measured by adverse events
Secondary Outcome Measures
Cmax of EDP-514
AUC of EDP-514
Change from baseline in HBV DNA Viral Load Assay
Full Information
NCT ID
NCT04470388
First Posted
July 10, 2020
Last Updated
January 6, 2022
Sponsor
Enanta Pharmaceuticals, Inc
Collaborators
Pharmaceutical Research Associates
1. Study Identification
Unique Protocol Identification Number
NCT04470388
Brief Title
A Study of EDP-514 in Patients With Chronic Hepatitis B Virus Infection Who Are Not Currently on Treatment
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 9, 2020 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Enanta Pharmaceuticals, Inc
Collaborators
Pharmaceutical Research Associates
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic HBV Infection
Keywords
Multiple Ascending Dose, hepatitis B virus, HBV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EDP-514 HBV MAD Cohorts
Arm Type
Experimental
Arm Description
EDP-514 capsule Dose 1, Dose 2 and Dose 3 orally, once daily for 28 days.
Arm Title
EDP-514 HBV MAD Placebo Cohort
Arm Type
Placebo Comparator
Arm Description
Matching placebo, orally, once daily for 28 days.
Intervention Type
Drug
Intervention Name(s)
EDP-514
Intervention Description
Oral Capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to match EDP-514
Primary Outcome Measure Information:
Title
Safety measured by adverse events
Time Frame
Up to 84 Days in HBV MAD Cohorts
Secondary Outcome Measure Information:
Title
Cmax of EDP-514
Time Frame
Up to 28 Days in HBV MAD Cohorts
Title
AUC of EDP-514
Time Frame
Up to 28 Days in HBV MAD Cohorts
Title
Change from baseline in HBV DNA Viral Load Assay
Time Frame
through Day 28 in HBV MAD Cohorts
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enanta Pharmaceuticals, Inc
Organizational Affiliation
Enanta Pharmaceuticals, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Changhua Christian Hospital
City
Changhua
ZIP/Postal Code
500209
Country
Taiwan
Facility Name
Chia-Yi Christian Hospital
City
Chiayi
ZIP/Postal Code
600566
Country
Taiwan
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
500209
Country
Taiwan
Facility Name
E-Da Hospital/E-DA Cancer Hospital
City
Kaohsiung
ZIP/Postal Code
824410
Country
Taiwan
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
833401
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404332
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704302
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100229
Country
Taiwan
Facility Name
Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch
City
Taoyuan
ZIP/Postal Code
333423
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
A Study of EDP-514 in Patients With Chronic Hepatitis B Virus Infection Who Are Not Currently on Treatment
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