Chronic Hepatitis B Virus (Hbv)Phase 1WGc0201-HBVNCT07051187
A Trial to Evaluate the Efficacy and Safety of WGc0201 in Patients With Chronic Hepatitis B Virus Infection
A Phase 1 study testing WGc0201 in people with Chronic Hepatitis B Virus (Hbv), run by Jiyan Liu at 1 site in China.
Trial summary
Existing nucleoside analogues (NAs) and interferon therapy for chronic hepatitis B (CHB) have limitations, including drug resistance, low HBsAg clearance rates, and irreversible immunosuppression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B Virus (Hbv)
- What is being tested?
- WGc0201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 1 Sep 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males or females aged ≥18 to ≤65 years;
- 18≤ BMI ≤32 kg/m2;
- Diagnosis of chronic hepatitis B infection (HBsAg positive for more than 6 months and detectable at screening);
- Received only nucleoside (acid) analog therapy in the 12 months prior to screening and are still taking it regularly;
- HBV-DNA viral load below 100 IU/ml;
- HBsAg <1500 IU/ml.
Who cannot join
- Includes HIV, co-infection with HDV, and liver biopsy suggestive of cirrhosis or advanced fibrosis within 6 months prior to screening (Metavir activity level A3 and stages F3 and F4; Ishak stages 4-6);
- If no liver biopsy was documented, a Fibroscan screen result >9 kPa (or equivalent) or a FibroTest screen result >0.48 and an APRI (Aspartate Aminotransferase to Platelet Ratio Index) >1 within ≤6 months of screening.
- Alanine aminotransferase >3x ULN;
- Internationally standardized ratio > 1.5;
- Albumin <3.5 g/dl;
- Direct bilirubin > 1.5x ULN;
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- Platelet count <100,000/μl;
- History of hepatic failure (e.g., ascites, encephalopathy, or variceal bleeding) or prior hepatocellular carcinoma;
- Diseases or past history of the following systems or serious illnesses that the investigator considers inappropriate for participation in this trial, such as: cardiovascular system: unstable or significant cardiovascular disease, such as angina pectoris, recent episode of myocardial infarction, congestive heart failure, severe hypertension, significant arrhythmia or ECG abnormality, etc.; respiratory system: bronchiectasis, bronchial asthma, chronic obstructive pulmonary disease, respiratory failure, etc.; endocrine and metabolic diseases: diabetes mellitus, thyroid disease poorly controlled by medication, etc.; others: autoimmune diseases, active tuberculosis, malignant diseases (e.g., tumors), history of neurological or psychiatric disorders, etc;
- Subjects who have participated in any drug/device clinical study within 3 months prior to receiving the experimental drug.
- History of organ transplantation (except corneal transplantation and hair transplantation).
- Those with alcoholism (alcohol consumption for more than 5 years prior to the screening period, with alcohol content greater than 40g per day for men and 20g per day for women) or known drug dependence.
- Subjects who have a birth plan or a plan to donate sperm or eggs during the screening period, during the trial, and for 6 months after the end of the trial or who are unwilling to use effective contraception.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Hong-Shuai Li, Dr, +86-18384262516, lihongshuai456@163.com
About this study
Official title: An Open-Label, Single-Arm, Dose-Escalation Phase I Clinical Trial to Evaluate the Efficacy and Safety of WGc0201 in Patients With Chronic Hepatitis B Virus Infection
Existing nucleoside analogues (NAs) and interferon therapy for chronic hepatitis B (CHB) have limitations, including drug resistance, low HBsAg clearance rates, and irreversible immunosuppression. Therapeutic vaccines, by activating virus-specific T cells and B cells, hold promise for achieving functional cure (HBsAg clearance + sustained HBV DNA negativity). This study is an open-label, single-arm, dose-escalation Phase I clinical trial. The study population consists of patients with chronic hepatitis B virus infection who have achieved virological stability following standard antiviral therapy. Phase I (dose exploration): three dose groups, with three patients per group. The primary objective is to observe and evaluate the safety of the WGc0201 vaccine in the study population (incidence and severity of adverse events).
Read the detailed description
Although current antiviral treatments have achieved some clinical efficacy, there is still a lack of treatments that can truly cure hepatitis B, especially those that can completely eliminate HBsAg and prevent viral recurrence. Therapeutic hepatitis B vaccines are considered a potential treatment option for chronic hepatitis B and drug-resistant hepatitis B patients in the future. The development goal of therapeutic vaccines is to activate the body's specific immune response, promote the immune system to recognize and eliminate the hepatitis B virus, thereby achieving virological clearance and functional cure. WGc-0201 injection is an mRNA vaccine encoding the HBV-positive tumor antigen HBx. Preliminary basic research conducted by the team suggests that this vaccine has excellent safety, not only effectively clearing HBV DNA but also reducing HBsAg levels in serum and liver tissue while enhancing the expansion of specific T lymphocytes in the body. Therefore, we believe that the efficacy and safety of WGc0201 in treating hepatitis B warrant further investigation. We aim to use this Phase I study to preliminarily explore the therapeutic efficacy and safety of WGc0201 in this population and lay the groundwork for future clinical trials.
- Conditions
- Chronic Hepatitis B Virus (Hbv)
- Being tested
- WGc0201
- Keywords
- mRNA, vaccine, chronic Hepatitis B virus
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WGc0201Drug
Wgc0201 will be administered by intramuscular route, with a total of 9 doses.
| Study group | Role | What they receive |
|---|---|---|
| WGc0201 | Experimental | Wgc0201 will be administered by intramuscular route, with a total of 9 doses Receives: Drug: WGc0201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
CATAE 5.0 standard
Measured: 12 weeks
Secondary outcomes (4)
Immunogenicity of the vaccine (HBV-specific T-cell response)
ELISpot test
Measured: 12 weeks
changes in virological indicators (HBV DNA/RNA)
qPCR、RT-qPCR
Measured: 12 weeks
changes in virological indicators (HBsAg)
CLIA/ECLIA
Measured: 12 weeks
changes in virological indicators (ALT normalization rate)
Kinetic (Rate) Assay
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis B Virus (Hbv)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiyan Liu
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital
- Responsible party
- Sponsor-investigator, Jiyan Liu, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051187
- Sponsor's protocol ID
- WGc0201-HBV-001
- Other IDs
- 274953
- Acronym
- WGc0201-HBV
- Status last verified
- Jun 2026
- First submitted
- 30 May 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm, Dose-Escalation Phase I Clinical Trial to Evaluate the Efficacy and Safety of WGc0201 in Patients With Chronic Hepatitis B Virus Infection
- ClinicalTrials.gov ID
- NCT07051187
- Acronym / sponsor ID
- WGc0201-HBV / WGc0201-HBV-001
- Conditions
- Chronic Hepatitis B Virus (Hbv)
- Keywords
- mRNA, vaccine, chronic Hepatitis B virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Jiyan LiuUniversity, hospital or other
- Collaborators
- West China Hospital
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 4 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Existing nucleoside analogues (NAs) and interferon therapy for chronic hepatitis B (CHB) have limitations, including drug resistance, low HBsAg clearance rates, and irreversible immunosuppression. Therapeutic vaccines, by activating virus-specific T cells and B cells, hold promise for achieving functional cure (HBsAg clearance + sustained HBV DNA negativity). This study is an open-label, single-arm, dose-escalation Phase I clinical trial. The study population consists of patients with chronic hepatitis B virus infection who have achieved virological stability following standard antiviral therapy. Phase I (dose exploration): three dose groups, with three patients per group. The primary objective is to observe and evaluate the safety of the WGc0201 vaccine in the study population (incidence and severity of adverse events).
Detailed description
Although current antiviral treatments have achieved some clinical efficacy, there is still a lack of treatments that can truly cure hepatitis B, especially those that can completely eliminate HBsAg and prevent viral recurrence. Therapeutic hepatitis B vaccines are considered a potential treatment option for chronic hepatitis B and drug-resistant hepatitis B patients in the future. The development goal of therapeutic vaccines is to activate the body's specific immune response, promote the immune system to recognize and eliminate the hepatitis B virus, thereby achieving virological clearance and functional cure. WGc-0201 injection is an mRNA vaccine encoding the HBV-positive tumor antigen HBx. Preliminary basic research conducted by the team suggests that this vaccine has excellent safety, not only effectively clearing HBV DNA but also reducing HBsAg levels in serum and liver tissue while enhancing the expansion of specific T lymphocytes in the body. Therefore, we believe that the efficacy and safety of WGc0201 in treating hepatitis B warrant further investigation. We aim to use this Phase I study to preliminarily explore the therapeutic efficacy and safety of WGc0201 in this population and lay the groundwork for future clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WGc0201 | Experimental | Drug: WGc0201Wgc0201 will be administered by intramuscular route, with a total of 9 doses |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult males or females aged ≥18 to ≤65 years;
- 18≤ BMI ≤32 kg/m2;
- Diagnosis of chronic hepatitis B infection (HBsAg positive for more than 6 months and detectable at screening);
- Received only nucleoside (acid) analog therapy in the 12 months prior to screening and are still taking it regularly;
- HBV-DNA viral load below 100 IU/ml;
Key exclusion criteria (13 listed)
- Includes HIV, co-infection with HDV, and liver biopsy suggestive of cirrhosis or advanced fibrosis within 6 months prior to screening (Metavir activity level A3 and stages F3 and F4; Ishak stages 4-6);
- If no liver biopsy was documented, a Fibroscan screen result >9 kPa (or equivalent) or a FibroTest screen result >0.48 and an APRI (Aspartate Aminotransferase to Platelet Ratio Index) >1 within ≤6 months of screening.
- Alanine aminotransferase >3x ULN;
- Internationally standardized ratio > 1.5;
- Albumin <3.5 g/dl;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WGc0201Wgc0201 will be administered by intramuscular route, with a total of 9 doses. | Drug | WGc0201 |
Primary outcome
Adverse events (AEs)
Time frame: 12 weeks
CATAE 5.0 standard
4 secondary outcomes
Immunogenicity of the vaccine (HBV-specific T-cell response)
Time frame: 12 weeks
changes in virological indicators (HBV DNA/RNA)
Time frame: 12 weeks
changes in virological indicators (HBsAg)
Time frame: 12 weeks
changes in virological indicators (ALT normalization rate)
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing WGc0201 in people with Chronic Hepatitis B Virus (Hbv), run by Jiyan Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong-Shuai Li, Dr (+86-18384262516, lihongshuai456@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.