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Not yet taking people in ChinaEarly phase 1

Tests EPI-003 injection for chronic hepatitis B in adults

Tests EPI-003, an intravenous drug, in adults with chronic hepatitis B.

Plain-language title generated from the registry record
Registry title: An Exploratory Clinical Study Evaluating EPI-003 Injection for the Treatment of Chronic Hepatitis B

Key facts

Where
Shanghai, ChinaSee the site
Phase
Early phase 1

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Source: NCT06745973, who can take part

Where in China

  • Renji Hospital Shanghai Jiao Tong University School of MedicineShanghai, ChinaNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Epigenic Therapeutics, Inc
Trial code
NCT06745973
Record updated
24 December 2024
Original description
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.Read full original descriptionShow less

An Exploratory Clinical Study Evaluating EPI-003 Injection for the Treatment of Chronic Hepatitis B

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.

Inclusion: 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: Confirmed diagnosis of liver cancer or cirrhosis; Combination of other major diseases; 3 Pregnant or lactating females.

ClinicalTrials.gov NCT06745973