Clinical trial NCT04470388: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic HBV Infection
Keywords: Multiple Ascending Dose
hepatitis B virus
HBV
Lead sponsor: Enanta Pharmaceuticals, Inc
Sponsor class: INDUSTRY
Collaborators: name: Pharmaceutical Research Associates
First posted: 2020-07-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety measured by adverse events
timeFrame: Up to 84 Days in HBV MAD Cohorts
Secondary outcomes:
measure: Cmax of EDP-514
timeFrame: Up to 28 Days in HBV MAD Cohorts
measure: AUC of EDP-514
timeFrame: Up to 28 Days in HBV MAD Cohorts
measure: Change from baseline in HBV DNA Viral Load Assay
timeFrame: through Day 28 in HBV MAD Cohorts
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Chiayi
country: Taiwan
facility: Chia-Yi Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: E-Da Hospital/E-DA Cancer Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch
Study officials:
affiliation: Enanta Pharmaceuticals, Inc
name: Enanta Pharmaceuticals, Inc
role: STUDY_DIRECTOR
References: