NCT06745973Not yet recruitingEarly phase 1
An Exploratory Clinical Study Evaluating EPI-003 Injection for the Treatment of Chronic Hepatitis B
Source: ClinicalTrials.gov · Last updated 24 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 9 Dec 2024
- Start date
- 20 Dec 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Epigenic Therapeutics, Inc
- Diseases
- Hepatitis B
- NCT number
- NCT06745973
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 20
- From 20 Dec 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Confirmed diagnosis of liver cancer or cirrhosis;
- Combination of other major diseases; 3 Pregnant or lactating females.
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Renji Hospital Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.