An Exploratory Clinical Study Evaluating EPI-003 Injection for the Treatment of Chronic Hepatitis B
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EPI-003.
- Who it may be relevant to
- Registry conditions: Chronic Hepatitis B. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
This study is an open-label, 2-Part (Single Ascending Dose \[Part 1\] And Dose Expansion) study that will evaluate the safety of EPI-003 administered to patients with chronic infection with HBV (CHB). EPI-003 is a liver-targeted antiviral therapeutic for intravenous (IV) injection that is capable of precise epigenetic modifications of the HBV genome without causing mutations in the gene sequence itself.
Interventions
- Drug EPI-003
Intravenous (IV) infusion.
Primary outcome measures
- Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs [Time frame: From Baseline through to Day 28 postdose]
Secondary outcome measures (4)
- Evaluation of maximum observed concentration (Cmax) [Time frame: From Baseline through to Day 28 postdose]
- Evaluation of maximum observed concentration (tmax) [Time frame: From Baseline through to Day 28 postdose]
- Evaluation of terminal elimination half-life (t1/2) [Time frame: From Baseline through to Day 28 postdose]
- HBsAg [Time frame: From Baseline through to Day 365 postdose]
Eligibility criteria
Inclusion criteria
- Be between 18 and 65 years of age, inclusive, at the time of signing the informed consent form;
- Confirmed diagnosis of CHB;
- Received a stable dose of NA therapy for ≥ 6 months prior to screening and plan to continue receiving the same dose for the duration of the study
Exclusion criteria
- Confirmed diagnosis of liver cancer or cirrhosis;
- Combination of other major diseases; 3 Pregnant or lactating females.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Renji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai
Identifiers
NCT: NCT06745973 · EPI-003-I01