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A Study of EDP-514 in Patients With Chronic Hepatitis B Virus Infection Who Are Not Currently on Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04470388
Recruitment Status : Recruiting
First Posted : July 14, 2020
Last Update Posted : May 10, 2021
Pharmaceutical Research Associates
Information provided by (Responsible Party):
Enanta Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Chronic HBV Infection Drug: EDP-514 Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: 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
Actual Study Start Date : September 9, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: EDP-514 HBV MAD Cohorts
EDP-514 capsule Dose 1, Dose 2 and Dose 3 orally, once daily for 28 days.
Drug: EDP-514
Oral Capsule

Placebo Comparator: EDP-514 HBV MAD Placebo Cohort
Matching placebo, orally, once daily for 28 days.
Drug: Placebo
Placebo to match EDP-514

Primary Outcome Measures :
  1. Safety measured by adverse events [ Time Frame: Up to 84 Days in HBV MAD Cohorts ]

Secondary Outcome Measures :
  1. Cmax of EDP-514 [ Time Frame: Up to 28 Days in HBV MAD Cohorts ]
  2. AUC of EDP-514 [ Time Frame: Up to 28 Days in HBV MAD Cohorts ]
  3. Change from baseline in HBV DNA Viral Load Assay [ Time Frame: through Day 28 in HBV MAD Cohorts ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04470388

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Contact: Enanta Pharmaceuticals, Inc +1 617 607 0705

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Hong Kong
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Contact: Man-Fung Yuen         
Changhua Christian Hospital Recruiting
Changhua, Taiwan, 500209
Contact: Wei-Wen Su         
Chia-Yi Christian Hospital Recruiting
Chiayi, Taiwan, 600566
Contact: Chi-Yi Chen         
Kaohsiung Medical University Chung-Ho Memorial Hospital Recruiting
Kaohsiung, Taiwan, 500209
Contact: Wan-Long Chuang         
E-Da Hospital/E-DA Cancer Hospital Recruiting
Kaohsiung, Taiwan, 824410
Contact: Yao-Chun Hsu         
Kaohsiung Chang Gung Memorial Hospital Recruiting
Kaohsiung, Taiwan, 833401
Contact: Chien-Hung Chen         
China Medical University Hospital Recruiting
Taichung, Taiwan, 404332
Contact: Cheng-Yuan Peng         
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 704302
Contact: Ting-Tsung Chang         
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100229
Contact: Pei-Jer Chen         
Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch Recruiting
Taoyuan, Taiwan, 333423
Contact: Wen-Juei Jeng         
Sponsors and Collaborators
Enanta Pharmaceuticals
Pharmaceutical Research Associates
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Study Director: Enanta Pharmaceuticals, Inc Enanta Pharmaceuticals, Inc
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Responsible Party: Enanta Pharmaceuticals Identifier: NCT04470388    
Other Study ID Numbers: EDP 514-002
First Posted: July 14, 2020    Key Record Dates
Last Update Posted: May 10, 2021
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Enanta Pharmaceuticals:
Multiple Ascending Dose
hepatitis B virus
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis B, Chronic
Communicable Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Blood-Borne Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic