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

Chronic HBV Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04470388
• Other study ID #: EDP 514-002
• Status: Completed
• Phase: Phase 1
• Start date: September 9, 2020
• Est. completion date: August 30, 2021

Study information

• Verified date: January 2022
• Source: Enanta Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic HBV Infection
• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic
• Infections

Intervention

Drug:
• EDP-514
Oral Capsule
• Placebo
Placebo to match EDP-514

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong
Taiwan	Changhua Christian Hospital	Changhua
Taiwan	Chia-Yi Christian Hospital	Chiayi
Taiwan	E-Da Hospital/E-DA Cancer Hospital	Kaohsiung
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch	Taoyuan

Sponsors (2)

Lead Sponsor	Collaborator
Enanta Pharmaceuticals	Pharmaceutical Research Associates

Countries where clinical trial is conducted

Hong Kong,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety measured by adverse events		Up to 84 Days in HBV MAD Cohorts
Secondary	Cmax of EDP-514		Up to 28 Days in HBV MAD Cohorts
Secondary	AUC of EDP-514		Up to 28 Days in HBV MAD Cohorts
Secondary	Change from baseline in HBV DNA Viral Load Assay		through Day 28 in HBV MAD Cohorts