Status:
COMPLETED
A Study of EDP-514 in Patients With Chronic Hepatitis B Virus Infection Who Are Not Currently on Treatment
Lead Sponsor:
Enanta Pharmaceuticals, Inc
Collaborating Sponsors:
Pharmaceutical Research Associates
Conditions:
Chronic HBV Infection
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 w...
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 subjec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04470388
Start Date
September 9 2020
End Date
August 30 2021
Last Update
January 11 2022
Active Locations (10)
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1
Queen Mary Hospital
Hong Kong, Hong Kong
2
Chia-Yi Christian Hospital
Chiayi City, Chiayi, Taiwan, 600566
3
Changhua Christian Hospital
Changhua, Taiwan, 500209
4
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 500209