Chronic Hepatitis B Virus InfectionPhase 2NCT07917910
A Study of HT-101 and HT-102 in Chronic Hepatitis B (CHB)
A Phase 2 study testing HT-101 + HT-102 in people with Chronic Hepatitis B Virus Infection, run by Suzhou HepaThera Biotech Co., Ltd..
Trial summary
Phase II trial of HT-101 + HT-102 in CHB: (1) functional cure in treatment-naïve patients (vs placebo); (2) efficacy of sequential interferon in previously treated patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis B Virus Infection
- What is being tested?
- HT-101 + HT-102
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2026to 17 Sep 2029
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having a full understanding of the nature, significance, possible benefits, and risks of this study, demonstrating good compliance, and voluntarily signing the Informed Consent Form (ICF)；
- Treatment-naïve participants clinically diagnosed with chronic Hepatitis B virus (HBV) infection;
- Male or female participants of childbearing potential (WOCBP) must commit to having no plans for procreation, sperm or ovum donation during the study and for 6 months after the last dose, and must voluntarily use a highly effective contraceptive method.
Who cannot join
- Previous history of cirrhosis, or evidence suggesting significant hepatic fibrosis or cirrhosis;
- History of hepatocellular carcinoma (HCC) or suspected HCC;
- Individuals who have experienced major trauma or undergone major surgery within 3 months prior to screening, or who plan to undergo major surgery during the study period;
- Previous history of solid organ transplantation or hematopoietic stem cell transplantation (HSCT);
- Pregnant or lactating women, or those with a positive pregnancy test;
- Known allergy to any component of the investigational product and/or other products of the same class, or history of severe food or drug allergy, or allergic constitution;
- Participants deemed by the investigator, for any other reason, to be unsuitable to participate in this study;
About this study
Official title: A Phase II Clinical Trial to Evaluate the Efficacy and Safety of HT-101 Injection in Combination With HT-102 Injection in Participants With Chronic Hepatitis B (CHB) Virus Infection
Phase II trial of HT-101 + HT-102 in CHB: (1) functional cure in treatment-naïve patients (vs placebo); (2) efficacy of sequential interferon in previously treated patients.
Read the detailed description
This is a Phase II clinical trial to evaluate the efficacy and safety of HT-101 Injection in combination with HT-102 Injection in participants with chronic hepatitis B virus infection. The primary objective is（1） to assess the efficacy of HT-101 Injection plus HT-102 Injection compared with placebo in achieving functional cure in treatment-naïve participants with chronic hepatitis B virus infection
- Conditions
- Chronic Hepatitis B Virus Infection
- Being tested
- HT-101 + HT-102, HT-101 placebo + HT-102 placebo
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HT-101 + HT-102Drug
HT-101 given by subcutaneous injection.HT-102 given by subcutaneous injection.
HT-101 placebo + HT-102 placeboDrug
HT-101 placebo + HT-102 placebo
| Study group | Role | What they receive |
|---|---|---|
| HT-101 + HT-102 | Experimental | Not described Receives: Drug: HT-101 + HT-102 |
| HT-101 placebo + HT-102 placebo | Experimental | Not described Receives: Drug: HT-101 placebo + HT-102 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving functional cure at Week 24 of follow-up after discontinuation of all anti-hepatitis B medications.
Measured: Up to Week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Oct 2028 (estimated)
- Study completion17 Sep 2029 (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 InfectionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou HepaThera Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917910
- Sponsor's protocol ID
- HT-101&HT-102-202
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial to Evaluate the Efficacy and Safety of HT-101 Injection in Combination With HT-102 Injection in Participants With Chronic Hepatitis B (CHB) Virus Infection
- ClinicalTrials.gov ID
- NCT07917910
- Acronym / sponsor ID
- HT-101&HT-102-202
- Conditions
- Chronic Hepatitis B Virus Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Suzhou HepaThera Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 17 Sep 2029 (estimated)
- First posted
- 5 Nov 2026 (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.
Phase II trial of HT-101 + HT-102 in CHB: (1) functional cure in treatment-naïve patients (vs placebo); (2) efficacy of sequential interferon in previously treated patients.
Detailed description
This is a Phase II clinical trial to evaluate the efficacy and safety of HT-101 Injection in combination with HT-102 Injection in participants with chronic hepatitis B virus infection. The primary objective is（1） to assess the efficacy of HT-101 Injection plus HT-102 Injection compared with placebo in achieving functional cure in treatment-naïve participants with chronic hepatitis B virus infection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HT-101 + HT-102 | Experimental | Drug: HT-101 + HT-102 |
| HT-101 placebo + HT-102 placebo | Experimental | Drug: HT-101 placebo + HT-102 placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having a full understanding of the nature, significance, possible benefits, and risks of this study, demonstrating good compliance, and voluntarily signing the Informed Consent Form (ICF)；
- Treatment-naïve participants clinically diagnosed with chronic Hepatitis B virus (HBV) infection;
- Male or female participants of childbearing potential (WOCBP) must commit to having no plans for procreation, sperm or ovum donation during the study and for 6 months after the last dose, and must voluntarily use a highly effective contraceptive method.
Key exclusion criteria (7 listed)
- Previous history of cirrhosis, or evidence suggesting significant hepatic fibrosis or cirrhosis;
- History of hepatocellular carcinoma (HCC) or suspected HCC;
- Individuals who have experienced major trauma or undergone major surgery within 3 months prior to screening, or who plan to undergo major surgery during the study period;
- Previous history of solid organ transplantation or hematopoietic stem cell transplantation (HSCT);
- Pregnant or lactating women, or those with a positive pregnancy test;
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 |
|---|---|---|
| HT-101 + HT-102HT-101 given by subcutaneous injection.HT-102 given by subcutaneous injection. | Drug | HT-101 + HT-102 |
| HT-101 placebo + HT-102 placeboHT-101 placebo + HT-102 placebo | Drug | HT-101 placebo + HT-102 placebo |
Primary outcome
Proportion of participants achieving functional cure at Week 24 of follow-up after discontinuation of all anti-hepatitis B medications.
Time frame: Up to Week 72
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 5 Nov 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HT-101 + HT-102 in people with Chronic Hepatitis B Virus Infection, run by Suzhou HepaThera Biotech Co., Ltd..
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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving functional cure at Week 24 of follow-up after discontinuation of all anti-hepatitis B medications. (time frame: Up to Week 72). 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 5 Nov 2026.