Hepatitis B, ChronicPhase 1/2NCT06452693
A Clinical Study to Evaluate the Efficacy of TQA3038 Injection in Patients With Chronic Hepatitis B
A Phase 1/2 study of Hepatitis B, Chronic, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 22 sites in China.
Trial summary
This study is divided into two parts. Phase Ib is a randomized, double-blind, placebo-controlled trial, designed to evaluate the safety, tolerability, pharmacokinetic characteristics, preliminary efficacy, and immunogenicity of TQA3038 injection in patients with chronic hepatitis B. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B, Chronic
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 22 sitesChina
- Study dates
- Jun 2024to Sep 2026
- Phase
- Phase 1/2
- 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
- Subjects voluntarily participate in this study and sign informed consent;
- Male and female ≥18 years old and ≤65 years old;
- Male subjects with a weight of ≥ 50 kilograms and female subjects with a weight of ≥ 45 kilograms, BMI 18~28 kg/m2;
- Patients diagnosed with chronic hepatitis B (CHB) who have been serum HBsAg positive for more than 6 months and HBeAg positive ; During the screening period, 100 IU/ml ≤ HBsAg quantification ≤ 5000 IU/ml;
- The subjects are able to communicate well with the researchers, voluntarily and can understand and follow the experimental protocol process to complete the study;
- The subjects (including partners) are willing to voluntarily adopt effective contraceptive measures during the clinical trial period and long-term follow-up period, and specific contraceptive measures are shown in the appendix;
- The treated patients need to meet the condition:The subject must have received oral nucleoside (acid) drug treatment and a stable treatment regimen;
- Newly treated patients must meet the condition:During screening, the subjects had never received antiviral treatment for chronic hepatitis B B (oral nucleoside (acid) drugs and interferon), or had irregular antiviral treatment in the past, but had not received any antiviral treatment for chronic hepatitis B 3 months before enrollment.
Who cannot join
- Pregnant and lactating women;
- Chronic diseases other than chronic HBV infection with significant clinical significance that have a history of mental illness or are deemed unsuitable by researchers for participation in this study;
- Acute diseases with significant clinical significance occurring within 7 days prior to receiving the investigational drug;
- Individuals with a history of active pathological bleeding or a tendency towards bleeding;
- Prescription medication has been used within 14 days prior to receiving the study drug;
- Receive any preventive or attenuated vaccines within 14 days prior to receiving the study drug;
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- Blood donors or those who have lost a significant amount of blood within the first 3 months of screening, or those who have donated blood during the planned study period;
- Subjects with a history of excessive alcohol consumption;
- A history of alcohol or drug abuse within the 12 months prior to screening, or a positive drug screening result during screening;
- Complicated with other infected disease;
- Patients with significant liver fibrosis or cirrhosis before or during screening;
- History of chronic liver diseases other than chronic HBV infection;
- Patients have a history of hepatocellular carcinoma (HCC) before or at the time of screening, or may be at risk for HCC;
- Used immunosuppressive or immunomodulatory drugs and cytotoxic drugs within 6 months prior to the study medication;
- During screening, subjects showed significant laboratory results abnormalities；
- Screening for tumors with a history of malignancy within the first 5 years, excluding tumors that can be completely cured through surgical resection;
- Uncontrollable chronic diseases;
- History of intolerance to subcutaneous injection;
- Participated in clinical studies of any drug or medical device within 3 months prior to drug administration or within 5 times the half-life of the investigational drug, or used the investigational drug;
- Those considered unsuitable for enrollment by the investigators.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
China22 sites
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233000
Chuanmiao Liu, Master, 13515528191, liuchuanmiao119@sina.com
The first hospital of Jilin University
Changchun, Jilin, 130061
Junqi Niu, Doctor, 13756661205, junqiniu@aliyun.com
Yanhua Ding, Doctor, 18186879768, dingyanhua2003@126.com
Hepatobiliary Hospital of Jilin
Changchun, Jilin, 130062
Hui Chen, Master, 0431-87609036, 737120047@qq.com
Xiangya Third Hospital of Central of Central Suoth University
Changsha, Hunan, 410000
Zhenguo Liu, Doctor, 13873129188, 441474918@qq.com
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Juan Wang, Doctor, 18980606472, 4082608@qq.com
The Southwest Hospital of AMU
Chongqing, 400038
Qing Mao, Doctor, 13594180020, qingmao@yahoo.com.cn
YongChuan Chen, Master, 17749922271, zwmcyc@163.com
The Second Affilated Hospital of Chongqing medical university
Chongqing, 400080
Peng Hu, Doctor, 13608338064, hp_cq@163.com
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, 350025
ZuXiong Huang, Doctor, 13599395269, 2556356068@qq.com
The Third Affiliated Hospital of Sun Yat sen University
Guangzhou, Guangdong, 510630
Liang Peng, Doctor, 13533978874, pliang@mail.sysu.edu.cn
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002
Xinhua Luo, Doctor, 13885039655, luoxh09@163.com
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000
Lei Yu, Doctor, 13804535357, widedoor@sian.com
Shandong Public Health Clinical Center
Jinan, Shandong, 250102
Zong Zhang, Master, 13082735135, zhangzong@163.com
Gansu province people hospital
Lanzhou, Gansu, 730030
Xiaojun Chen, Doctor, 18919845236, chenxj0932@163.com
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000
Xiaoping Wu, Doctor, 13330122823, wuxiaoping2823@aliyun.com
The First Affiliated Hospital of GUANGXI Medical University
Nanning, Guangxi, 530021
Minghua Su, Master, 15807719292, smh9292@163.com
Shanghai Tongren Hospital
Shanghai, 200000
Qin Zhang, Doctor, 18121226778, zhangq1030@163.com
The sixth people's hospital at of Shenyang
Shenyang, Liaoning, 110006
Xia Ti an, Master, 18502460861, 64565043@qq.com
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning, 110136
Yang Ding, Doctor, 13332434847, yding0903@sina.com
Shiyan City Taihe Hospital
Shiyan, Hubei, 442000
Zhongji Meng, Doctor, 13972505757, zhongji.meng@163.com
People's Hospital of Tianjin (City)
Tianjin, 300000
Tao Han, Doctor, 15522242551, hantaomd@126.com
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054
Xiaobo Lu, Doctor, 15999176214, xjykdluxiaobo@126.com
Tongji Hospital of Tongji medical college of HUST
Wuhan, Hubei, 430030
Qin Ning, Doctor, 13971521450, qning@vip.sina.com
About this study
Official title: A Phase Ib/IIa Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic, and Antiviral Efficacy of TQA3038 Injection in Patients With Chronic Hepatitis B
This study is divided into two parts. Phase Ib is a randomized, double-blind, placebo-controlled trial, designed to evaluate the safety, tolerability, pharmacokinetic characteristics, preliminary efficacy, and immunogenicity of TQA3038 injection in patients with chronic hepatitis B. It is expected to include 72 subjects. Phase IIa adopted an open-label, randomized, parallel-controlled design, with a total of 90 subjects included, mainly evaluating the changes in serum HBsAg compared to baseline at the end of the 48th week.
- Conditions
- Hepatitis B, Chronic
- Being tested
- TQA3038 injection/placebo, Nucleotide drugs Control group
- 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.
TQA3038 injection/placeboDrug
TQA3038 is a Anti-Hepatitis B virus (HBV) drugs.
Nucleotide drugs Control groupDrug
Nucleotide drugs are nucleoside reverse transcriptase inhibitors.
| Study group | Role | What they receive |
|---|---|---|
| TQA3038 injection/placebo | Experimental | 100/0mg~400/0mg, subcutaneous injection, 2 weeks~8 weeks as a cycle, a total of 2 doses.
Nucleotide drugs: Oral, once a day, orally administered with food, for 16 weeks. Receives: Drug: TQA3038 injection/placebo |
| Nucleotide drugs Control group | Active comparator | Nucleotide drugs: Oral, once a day, orally administered with food, for 48weeks. Receives: Drug: Nucleotide drugs Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
The incidence of adverse events (AEs) during treatment.
Measured: Baseline up to 16 weeks
Serious adverse events (SAEs)
The incidence of serious adverse events (SAEs) during treatment.
Measured: Baseline up to 16 weeks
Hepatitis B virus surface antigen (HbsAg)
Changes of serum HbsAg compared with baseline at the 48th week of treatment in each group.
Measured: Baseline up to 48 weeks
Secondary outcomes (10)
Time to Reach Maximum Plasma Concentration (Tmax)
Time to reach Cmax of TQA3038 and its metabolite in plasma.
Measured: Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose
Maximum Plasma Concentration (Cmax)
Maximum concentration of TQA3038 and its metabolite in plasma.
Measured: Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose
Area Under the Plasma Concentration Versus Time Curve (AUC)
Area under the curve of TQA3038 and its metabolite from time 0 to last measurable time.
Measured: Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose
Volume of distribution (Vd/F)
Volume of distribution (Vd/F) of TQA3038 in Plasma.
Measured: Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose
Apparent Plasma Clearance (CL/F)
Apparent Plasma Clearance (CL/F) of TQA3038 in Plasma.
Measured: Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose
Apparent Terminal Elimination Half-life (t1/2)
Apparent Elimination Half-life (T1/2) of TQA3038 in Plasma
Measured: Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose
The incidence and titer of anti drug antibodies (ADA)
The incidence and titer of anti drug antibodies (ADA) in serum.
Measured: Day1 before administration, Week 8, Week 16, and during withdrawal
Incidence of Neutralization antibody (Nab)
Incidence of Neutralization antibody (Nab) in serum.
Measured: Day1 before administration, Week 8, Week 16, and during withdrawal
Hepatitis B surface antigen (HBsAg)
Changes in Hepatitis B surface antigen (HbsAg) levels from baseline during the study period.
Measured: Baseline up to 48 weeks
Hepatitis B E antigen (HBeAg)
Changes in HbeAg levels from baseline during the study period.
Measured: Baseline up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study startJun 2024 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 162 participants (estimated)
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
- NCT06452693
- Sponsor's protocol ID
- TQA3038-Ib/IIa-01
- Status last verified
- Mar 2024
- First submitted
- 6 Jun 2024
- Last updated
- 11 Jun 2024
- 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 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/IIa Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic, and Antiviral Efficacy of TQA3038 Injection in Patients With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT06452693
- Acronym / sponsor ID
- TQA3038-Ib/IIa-01
- Conditions
- Hepatitis B, Chronic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2024 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 11 Jun 2024 (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 study is divided into two parts. Phase Ib is a randomized, double-blind, placebo-controlled trial, designed to evaluate the safety, tolerability, pharmacokinetic characteristics, preliminary efficacy, and immunogenicity of TQA3038 injection in patients with chronic hepatitis B. It is expected to include 72 subjects. Phase IIa adopted an open-label, randomized, parallel-controlled design, with a total of 90 subjects included, mainly evaluating the changes in serum HBsAg compared to baseline at the end of the 48th week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TQA3038 injection/placebo | Experimental | Drug: TQA3038 injection/placebo100/0mg~400/0mg, subcutaneous injection, 2 weeks~8 weeks as a cycle, a total of 2 doses. Nucleotide drugs: Oral, once a day, orally administered with food, for 16 weeks. |
| Nucleotide drugs Control group | Active comparator | Drug: Nucleotide drugs Control groupNucleotide drugs: Oral, once a day, orally administered with food, for 48weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects voluntarily participate in this study and sign informed consent;
- Male and female ≥18 years old and ≤65 years old;
- Male subjects with a weight of ≥ 50 kilograms and female subjects with a weight of ≥ 45 kilograms, BMI 18~28 kg/m2;
- Patients diagnosed with chronic hepatitis B (CHB) who have been serum HBsAg positive for more than 6 months and HBeAg positive ; During the screening period, 100 IU/ml ≤ HBsAg quantification ≤ 5000 IU/ml;
- The subjects are able to communicate well with the researchers, voluntarily and can understand and follow the experimental protocol process to complete the study;
Key exclusion criteria (20 listed)
- Pregnant and lactating women;
- Chronic diseases other than chronic HBV infection with significant clinical significance that have a history of mental illness or are deemed unsuitable by researchers for participation in this study;
- Acute diseases with significant clinical significance occurring within 7 days prior to receiving the investigational drug;
- Individuals with a history of active pathological bleeding or a tendency towards bleeding;
- Prescription medication has been used within 14 days prior to receiving the study drug;
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 |
|---|---|---|
| TQA3038 injection/placeboTQA3038 is a Anti-Hepatitis B virus (HBV) drugs. | Drug | TQA3038 injection/placebo |
| Nucleotide drugs Control groupNucleotide drugs are nucleoside reverse transcriptase inhibitors. | Drug | Nucleotide drugs Control group |
Primary outcome
Adverse events (AEs)
Time frame: Baseline up to 16 weeks
The incidence of adverse events (AEs) during treatment.
Serious adverse events (SAEs)
Time frame: Baseline up to 16 weeks
The incidence of serious adverse events (SAEs) during treatment.
Hepatitis B virus surface antigen (HbsAg)
Time frame: Baseline up to 48 weeks
Changes of serum HbsAg compared with baseline at the 48th week of treatment in each group.
10 secondary outcomes
Time to Reach Maximum Plasma Concentration (Tmax)
Time frame: Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose
Maximum Plasma Concentration (Cmax)
Time frame: Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose
Area Under the Plasma Concentration Versus Time Curve (AUC)
Time frame: Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose
Volume of distribution (Vd/F)
Time frame: Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose
Apparent Plasma Clearance (CL/F)
Time frame: Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose
Apparent Terminal Elimination Half-life (t1/2)
Time frame: Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose
The incidence and titer of anti drug antibodies (ADA)
Time frame: Day1 before administration, Week 8, Week 16, and during withdrawal
Incidence of Neutralization antibody (Nab)
Time frame: Day1 before administration, Week 8, Week 16, and during withdrawal
Hepatitis B surface antigen (HBsAg)
Time frame: Baseline up to 48 weeks
Hepatitis B E antigen (HBeAg)
Time frame: Baseline up to 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
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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.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study of Hepatitis B, Chronic, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 22 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 8 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: status not confirmed, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qin Ning, Doctor (13971521450, qning@vip.sina.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: Baseline up to 16 weeks). The study lists 3 primary outcomes in all. 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 11 Jun 2024.