An Early Phase 1 interventional study of EPI-003 in Chronic Hepatitis B, sponsored by Epigenic Therapeutics, Inc. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-12-24.
Sponsored by Epigenic Therapeutics, Inc · Early Phase 1, Interventional, and Treatment
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Among 374 studies in Hepatitis B, Chronic with a site in China — 88 open to participants now, 109 under way, 7 of them phase 3. Hepatitis B, Chronic · China.
Among the 374 studies in Hepatitis B, Chronic with a site in China, this one is the 256th largest by planned enrollment of the 273 interventional ones that give a count, is one of 34 that started in 2024, is one of 50 in phase 1, reaches primary completion later than 41 of the 108 other live ones, and was the 305th registered.
895 studies on the registry are indexed under Hepatitis B, Chronic; 152 are open to participants now.
Browse Hepatitis B, Chronic studies →88 of the 374 studies in Hepatitis B, Chronic with a site in China are open now. Recruiting first, the newest first:
Jiyan Liu · Sites in China
Ages 18–65
Fujian Shengdi Pharmaceutical Co., Ltd. · Sites in China
Ages 18+
Fujian Akeylink Biotechnology Co., Ltd. · Sites in China
Ages 35–65
Ausper Biopharma Co., Ltd. · Sites in China
Ages 18–65 · Healthy volunteers
Zhiliang Gao · Sites in China
Ages 18–65 · Healthy volunteers
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 97 Hepatitis B, Chronic studies recruiting now, 33 (34%) set no upper age limit and 59 (61%) stop at 75 or younger; 11 take children under 18; 13 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
374 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 62 · Phase 2 85 · Phase 3 27 · Phase 4 73
First in 2000; this study’s year is marked. 34 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 20 is below the median of 100 across 659 interventional studies indexed under Hepatitis B, Chronic.
Median enrollment 120 across the 273 interventional studies, 500 across the 98 observational. Of the 151 that completed or were terminated, 29 (19%) have results posted.
This tab as a report to print or save as PDF → With an account.
167 of 374 have an industry lead sponsor. The 10 most frequent:
Epigenic Therapeutics, Inc is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Epigenic Therapeutics, Inc has 2 studies filed under Hepatitis B, Chronic — fewer than ten, so there is no comparison to draw.
38 of the studies in Hepatitis B, Chronic with a site in China that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07090759Phase 3Fujian Akeylink Biotechnology Co., Ltd.To Evaluate the Efficacy, Safety and Population Pharmacokinetics of GST-HG141 in Patients With Chronic Hepatitis B (CHB) Who Have an Inadequate Response to Antiviral Drug Treatment | 2026-12-01 |
| NCT07246889Phase 3Ausper Biopharma Co., Ltd.Study of AHB-137 in Participants With Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogues (NAs)(AUSHINE) | 2026-12-18 |
| NCT07307586Phase 3Zhigang RenA Small Sample Prospective Clinical Study of Azvudine Tablets to Promote Clinical Cure in Patients With Chronic Hepatitis B | 2026-12-31 |
| NCT07203118Phase 3Xi'an Xintong Pharmaceutical Research Co.,Ltd.A Phase II/III of Hepenofovir Fumarate Tablets (HTS) for Chronic Hepatitis B | 2027-06-30 |
| NCT02863757Humanity and Health Research CentreFollow-up of Chronic Hepatitis B Patients With Comorbid Nonalcoholic Fatty Liver Disease | 2026-12 |
Add all 38 to your calendar (.ics) → With an account.
Among the 374 studies in Hepatitis B, Chronic with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: EPI-003
Intravenous (IV) infusion.
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs
Time frame: From Baseline through to Day 28 postdose
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
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Time frame: From Baseline through to Day 365 postdose
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2024; primary completion for Dec 2026, 24 months later.
Of 73 industry-sponsored phase 1 interventional studies under Hepatitis B, Chronic, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 24 months is above that.
Counting every sponsor, half of 81 studies reached it within 16 months; a quarter within 6 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Epigenic Therapeutics, Inc