Chronic Hepatitis BPhase 2NCT06990776
A Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive Chronic HBV-infected Subjects
A Phase 2 study testing TQA3605 Tablets and Entecavir dispersible tablets in people with Chronic Hepatitis B, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 29 sites in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled phase II study, in which all participants are required to use TQA3605 tablets/placebo in combination with entecavir. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- TQA3605 Tablets and Entecavir dispersible tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 29 sitesChina
- Study dates
- 9 Jul 2025to 17 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- 18-65 years old (including boundary values), regardless of gender;
- Screening requires virological , clinical or pathological evidence of hepatitis B virus infection for more than 6 months; HBsAg positive, HBeAg positive, ALT≤5×ULN at screening;
- Never received nucleoside (acid) analog or interferon treatment, or previously received no more than 12 weeks of treatment but had discontinued therapy at least 6 months prior to the screening visit;
- Ability to communicate effectively with researchers and understand and comply with the requirements of this study, understand and sign the informed consent form;
- Male subjects with female partners who have fertility or female subjects of childbearing age are willing to voluntarily adopt effective contraceptive measures screening to within 3 months after leaving the group.
Who cannot join
- Pregnant (positive pregnancy test) or lactating women.
- Co-infection with other viruses such as Hepatitis A Virus (HAV), Hepatitis C Virus (HCV), Hepatitis D Virus (HDV), Hepatitis E Virus (HEV), Human Immunodeficiency Virus (HIV), Syphilis, etc.;
- History of cirrhosis or evidence of significant fibrosis or cirrhosis before or during screening;
- History of hepatocellular carcinoma (HCC) or suspected HCC before or during screening.;
- History of malignant tumors within the past 5 years prior to screening, except for certain cancers that can be completely cured by surgical resection;
- Subjects with other chronic liver diseases, including but not limited to autoimmune liver disease, alcoholic liver disease, Wilson's disease, Gilbert syndrome, etc;
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- Previous organ or bone marrow transplantation;
- Clinically significant abnormal laboratory test results at screening.
- Poorly controlled thyroid diseases or clinically significant thyroid dysfunction;
- Autoimmune diseases;
- Significant systemic or major illnesses other than liver disease.
- Any systemic anti-tumor or immunosuppressive therapy, or immunomodulatory therapy within 6 months prior to screening.
- High-dose systemic corticosteroids use within 3 months prior to screening;
- History of alcohol or drug abuse within the past year or excessive alcohol consumption.
- History of blood transfusion within 2 months prior to screening;
- History of allergy to investigational drug or its excipients.
- Previously participated in the clinical trial of hepatitis B core protein allosteric modulators;
- Participation in another clinical trial and receipt of an investigational drug within the following timeframes before the first dose in this study: 5 half-lives (if known) or twice the duration of the biological effect of the study treatment (if known), whichever is longer, or 90 days (if the half-life or duration is unknown);
- History or condition of cardiovascular disease;
- Any other condition deemed inappropriate for inclusion by the investigator.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
China29 sites
Beijing Ditan Hospital Capital Medical University
Beijing, Beijing Municipality, 100015
Beijing Youan Hospital,Capital Medical University
Beijing, Beijing Municipality, 100069
The First Hospital of Jilin University
Changchun, Jilin, 130021
The First Hospital of Changsha
Changsha, Hunan, 410005
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
The Southwest Hospital of AMU
Chongqing, Chongqing Municipality, 400038
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, 350025
NanFang Hospital
Guangzhou, Guangdong, 510515
The Second Hospital of Shandong University
Jinan, Shandong, 250033
Shandong Provincial Clinical Center for Public Health
Jinan, Shandong, 250102
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210003
The Second Hospital of Nanjing
Nanjing, Jiangsu, 210003
Naniing Drum Tower Hospital
Nanjing, Jiangsu, 210008
The First Affiliated Hospital of GUANGXI Medical University
Nanning, Guangxi, 530021
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200000
Shanghai Tongren Hospital
Shanghai, Shanghai Municipality, 200336
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning, Liaoning
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, 050000
The Fifth People's Hospital of Suzhou
Suzhou, Jiangsu, 215131
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830013
The Fifth People's Hospital of Wuxi
Wuxi, Jiangsu, 214061
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, 710000
Xi'an Jiaotong University Second Affiliated Hospital
Xi'an, Shaanxi, 710000
Yiwu Central Hospital
Yiwu, Zhejiang, 322099
Zhengzhou No.6 peoples Hospital
Zhengzhou, Henan, 450000
Henan Provincial People's Hospital
Zhengzhou, Henan, 450002
Zhenjiang Third People's Hospital
Zhenjiang, Jiangsu, 212004
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive HBeAg-positive Subjects With Chronic HBV Infection
This is a multicenter, randomized, double-blind, placebo-controlled phase II study, in which all participants are required to use TQA3605 tablets/placebo in combination with entecavir. The purpose is to evaluate the efficacy and safety of TQA3605 tablets combined with entecavir in treatment-naive chronic HBV-infected subjects. A total of 215 subjects are required.
- Conditions
- Chronic Hepatitis B
- Being tested
- TQA3605 tablets Placebo, TQA3605 Tablets, Entecavir dispersible tablets
- 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.
TQA3605 tablets PlaceboDrug
Placebo contains no active substance.
TQA3605 TabletsDrug
TQA3605 tablets is core protein allosteric modulators
Entecavir dispersible tabletsDrug
Entecavir dispersible tablets is an inhibitor of hepatitis B virus replication.
| Study group | Role | What they receive |
|---|---|---|
| 100mg TQA3605 tablets + entecavir (ETV) (PART A) | Experimental | Patients aged 30-65 years old group：TQA3605 tablets, 100mg once a day, orally for 48 weeks in combination with entecavir, followed by treatment with entecavir for 24 weeks Receives: Drug: TQA3605 Tablets; Drug: Entecavir dispersible tablets |
| 200mg TQA3605 tablets +ETV (PART A) | Experimental | Patients aged 30-65 years old group：TQA3605 tablets, 200mg once a day, orally for 48 weeks in combination with entecavir, followed by treatment with entecavir for 24 weeks Receives: Drug: TQA3605 Tablets; Drug: Entecavir dispersible tablets |
| TQA3605 tablets Placebo +ETV (PART A) | Placebo comparator | Patients aged 30-65 years old group： TQA3605 tablets placebo, once a day, orally for 48 weeks in combination with entecavir, followed by treatment with entecavir for 24 weeks. Receives: Drug: TQA3605 tablets Placebo |
| 200mg TQA3605 tablets +ETV (PART B) | Experimental | Patients aged 18-30 years old group：TQA3605 tablets, 200mg once a day, orally for 48 weeks in combination with entecavir, followed by treatment with entecavir for 24 weeks. Receives: Drug: TQA3605 Tablets; Drug: Entecavir dispersible tablets |
| TQA3605 tablets Placebo +ETV (PART B) | Placebo comparator | Patients aged 18-30 years old group：TQA3605 tablets Placebo taken once a day, orally for 48 weeks in combination with entecavir, followed by treatment with entecavir for 24 weeks. Receives: Drug: TQA3605 tablets Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
hepatitis B virus (HBV) DNA <10 IU/mL
Percentage of subjects with HBV DNA below the lower limit of quantification (<10 IU/mL) after 48 weeks of treatment.
Measured: 48 weeks
Secondary outcomes (8)
Percentage of subjects with HBV DNA<10 IU/mL
Percentage of subjects with HBV DNA<10 IU/mL at week 12, 24, 36, 60, and 72
Measured: 12 weeks, 24 weeks, 36 weeks, 60 weeks, 72 weeks
Percentage of HBV DNA<20 IU/mL
Percentage of subjects with HBV DNA<20 IU/mL at weeks 12, 24, 36, 48, 60, and 72 of treatment.
Measured: 12 weeks, 24 weeks, 36 weeks, 48weeks, 60 weeks, 72 weeks
Percentage of subjects with HBeAg serologic clearance and/or serologic conversion
Percentage of subjects with HBeAg serologic clearance and/or serologic conversion
Measured: 24weeks, 48 weeks, 72 weeks
Alanine aminotransferase(ALT)≤The upper limit of the normal reference value (ULN)
The rate of ALT normalization at weeks 24, 48, and 72 of treatment
Measured: 24weeks, 48 weeks, 72 weeks
Virology breakthrough percentage
Percentage of subjects who experienced virological breakthroughs at weeks 24, 48, and 72 of treatment
Measured: 24weeks, 48 weeks, 72 weeks
Actual values of HBV markers and changes over time relative to baseline
Actual values of HBsAg, HBeAg, HBV DNA, HBV RNA, and Hepatitis B core-related antigen (HBcrAg) at each visit time point and their changes over time relative to baseline.
Measured: 12 weeks, 24 weeks, 36 weeks, 48 weeks, 72 weeks
Adverse events (AE)
The incidence and severity of adverse events.
Measured: 72 weeks
Steady state minimum concentration (Cmin,ss)
Cmin,ss of TQA3605 and its metabolite
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start9 Jul 2025
- Primary completion17 Jul 2025
- Study completion17 Jul 2025
Why it stopped: Per sponsor request. Premature closure was not prompted by any safety or efficacy concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990776
- Sponsor's protocol ID
- TQA3605-II-02
- Status last verified
- Feb 2025
- First submitted
- 18 May 2025
- Last updated
- 3 Aug 2025
- 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 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive HBeAg-positive Subjects With Chronic HBV Infection
- ClinicalTrials.gov ID
- NCT06990776
- Acronym / sponsor ID
- TQA3605-II-02
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Per sponsor request. Premature closure was not prompted by any safety or efficacy concerns.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- 17 Jul 2025 (actual)
- Study completion
- 17 Jul 2025 (actual)
- First posted
- 25 May 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.
This is a multicenter, randomized, double-blind, placebo-controlled phase II study, in which all participants are required to use TQA3605 tablets/placebo in combination with entecavir. The purpose is to evaluate the efficacy and safety of TQA3605 tablets combined with entecavir in treatment-naive chronic HBV-infected subjects. A total of 215 subjects are required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 100mg TQA3605 tablets + entecavir (ETV) (PART A) | Experimental | Drug: TQA3605 Tablets, Drug: Entecavir dispersible tabletsPatients aged 30-65 years old group：TQA3605 tablets, 100mg once a day, orally for 48 weeks in combination with entecavir, followed by treatment with entecavir for 24 weeks |
| 200mg TQA3605 tablets +ETV (PART A) | Experimental | Drug: TQA3605 Tablets, Drug: Entecavir dispersible tabletsPatients aged 30-65 years old group：TQA3605 tablets, 200mg once a day, orally for 48 weeks in combination with entecavir, followed by treatment with entecavir for 24 weeks |
| TQA3605 tablets Placebo +ETV (PART A) | Placebo comparator | Drug: TQA3605 tablets PlaceboPatients aged 30-65 years old group： TQA3605 tablets placebo, once a day, orally for 48 weeks in combination with entecavir, followed by treatment with entecavir for 24 weeks. |
| 200mg TQA3605 tablets +ETV (PART B) | Experimental | Drug: TQA3605 Tablets, Drug: Entecavir dispersible tabletsPatients aged 18-30 years old group：TQA3605 tablets, 200mg once a day, orally for 48 weeks in combination with entecavir, followed by treatment with entecavir for 24 weeks. |
| TQA3605 tablets Placebo +ETV (PART B) | Placebo comparator | Drug: TQA3605 tablets PlaceboPatients aged 18-30 years old group：TQA3605 tablets Placebo taken once a day, orally for 48 weeks in combination with entecavir, followed by treatment with entecavir for 24 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-65 years old (including boundary values), regardless of gender;
- Screening requires virological , clinical or pathological evidence of hepatitis B virus infection for more than 6 months; HBsAg positive, HBeAg positive, ALT≤5×ULN at screening;
- Never received nucleoside (acid) analog or interferon treatment, or previously received no more than 12 weeks of treatment but had discontinued therapy at least 6 months prior to the screening visit;
- Ability to communicate effectively with researchers and understand and comply with the requirements of this study, understand and sign the informed consent form;
- Male subjects with female partners who have fertility or female subjects of childbearing age are willing to voluntarily adopt effective contraceptive measures screening to within 3 months after leaving the group.
Key exclusion criteria (20 listed)
- Pregnant (positive pregnancy test) or lactating women.
- Co-infection with other viruses such as Hepatitis A Virus (HAV), Hepatitis C Virus (HCV), Hepatitis D Virus (HDV), Hepatitis E Virus (HEV), Human Immunodeficiency Virus (HIV), Syphilis, etc.;
- History of cirrhosis or evidence of significant fibrosis or cirrhosis before or during screening;
- History of hepatocellular carcinoma (HCC) or suspected HCC before or during screening.;
- History of malignant tumors within the past 5 years prior to screening, except for certain cancers that can be completely cured by surgical resection;
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 |
|---|---|---|
| TQA3605 tablets PlaceboPlacebo contains no active substance. | Drug | TQA3605 tablets Placebo +ETV (PART A), TQA3605 tablets Placebo +ETV (PART B) |
| TQA3605 TabletsTQA3605 tablets is core protein allosteric modulators | Drug | 100mg TQA3605 tablets + entecavir (ETV) (PART A), 200mg TQA3605 tablets +ETV (PART A), 200mg TQA3605 tablets +ETV (PART B) |
| Entecavir dispersible tabletsEntecavir dispersible tablets is an inhibitor of hepatitis B virus replication. | Drug | 100mg TQA3605 tablets + entecavir (ETV) (PART A), 200mg TQA3605 tablets +ETV (PART A), 200mg TQA3605 tablets +ETV (PART B) |
Primary outcome
hepatitis B virus (HBV) DNA <10 IU/mL
Time frame: 48 weeks
Percentage of subjects with HBV DNA below the lower limit of quantification (<10 IU/mL) after 48 weeks of treatment.
8 secondary outcomes
Percentage of subjects with HBV DNA<10 IU/mL
Time frame: 12 weeks, 24 weeks, 36 weeks, 60 weeks, 72 weeks
Percentage of HBV DNA<20 IU/mL
Time frame: 12 weeks, 24 weeks, 36 weeks, 48weeks, 60 weeks, 72 weeks
Percentage of subjects with HBeAg serologic clearance and/or serologic conversion
Time frame: 24weeks, 48 weeks, 72 weeks
Alanine aminotransferase(ALT)≤The upper limit of the normal reference value (ULN)
Time frame: 24weeks, 48 weeks, 72 weeks
Virology breakthrough percentage
Time frame: 24weeks, 48 weeks, 72 weeks
Actual values of HBV markers and changes over time relative to baseline
Time frame: 12 weeks, 24 weeks, 36 weeks, 48 weeks, 72 weeks
Adverse events (AE)
Time frame: 72 weeks
Steady state minimum concentration (Cmin,ss)
Time frame: 48 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TQA3605 Tablets and Entecavir dispersible tablets in people with Chronic Hepatitis B, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 29 sites 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 5 inclusion and 20 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: withdrawn, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
hepatitis B virus (HBV) DNA <10 IU/mL (time frame: 48 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 3 Aug 2025.