Treatment of Chronic Hepatitis B with TQA3605 Tablets and Nucleoside Analogs

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treated Subjects With Chronic HBV Infection With Low-level Viremia (LLV)

This study is testing if a new tablet called TQA3605, when taken with other medications, can help people with chronic Hepatitis B feel better compared to just taking the usual medications.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 21 sites (Beijing, Beijing and 20 other locations)
• Trial ID: NCT06644417 on ClinicalTrials.gov

What this trial studies

This phase II clinical trial evaluates the efficacy and safety of TQA3605 tablets when combined with nucleoside analogs (NAs) in patients with chronic Hepatitis B virus (HBV) infection. The study is multicenter, randomized, and double-blind, comparing the new treatment combination against a placebo plus NAs. Participants will be monitored for improvements in their HBV infection status and overall health outcomes. The trial aims to demonstrate that the combination therapy is more effective than NAs alone.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with chronic HBV infection who have been on nucleoside analogs for at least one year.

Not a fit: Patients with co-infections of other hepatitis viruses or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective option for managing chronic HBV infection, potentially leading to better patient outcomes.

How similar studies have performed: Other studies have shown promise in using combination therapies for HBV, but the specific approach with TQA3605 is novel.

Eligibility criteria

Inclusion Criteria:

* Ages 18-65 (including boundary values), male or female.
* At the time of screening, etiological or clinical or pathological evidence of hepatitis B virus infection has been more than 1 year; HBsAg positive, 20 IU/mL \<HBV DNA≤2000 IU/mL, ALT≤3×ULN (upper limit of normal); No obvious cirrhosis was found by the researchers.
* Continuous administration of any nucleoside (acid) analogues for more than 1 year and a stable regimen of ≥6 months prior to screening.
* Able to communicate well with researchers, understand and comply with the requirements of the study, understand and sign the informed consent.
* Male subjects with fertile female partners or female subjects of childbearing age were willing to voluntarily take effective contraceptive measures within 3 months after screening.

Exclusion Criteria:

* Pregnant (positive pregnancy test) or breastfeeding women.
* Co-infection with other viruses such as hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, human immunodeficiency virus, syphilis.
* A history of cirrhosis or evidence of significant fibrosis or cirrhosis at pre-screening/screening time.
* The subject had a history of hepatocellular carcinoma (HCC) before or at the time of screening, or was suspected of HCC.
* A history of malignant tumors within 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, and hepatolenticular degeneration.
* Have previously received organ transplantation and bone marrow transplantation.
* Abnormal laboratory examination indicators that do not meet the requirements of the program during screening.
* Poorly controlled thyroid disease, or clinically significant thyroid dysfunction.
* Autoimmune diseases include but are not limited to: systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, sarcoidosis, psoriasis, autoimmune uveitis, etc.;
* In addition to liver disease, there are significant systemic or major diseases, including recent congestive heart failure, unstable coronary heart disease, arterial revasodilation, respiratory disease, digestive disease, renal insufficiency, stroke, transient ischemic attack, organ transplantation, psychiatric disease, etc. Uncontrolled systemic disease: poor blood pressure control; Diabetes has poor blood sugar control.
* Received any systemic antitumor (including radiation) or immunosuppressive therapy (including biological immune inhibitors), or immunomodulatory therapy (including non-biological immunomodulatory oral drugs) in the 6 months prior to screening.
* Receiving high doses of systemic corticosteroids within 3 months prior to the screening period.
* A history of alcohol and drug abuse within 1 year prior to the screening period.
* Blood transfusion ≤2 months before screening and/or blood donation ≤1 month before screening. Note: Participants were not allowed to donate blood throughout the study period.
* Have a history of allergy to the experimental drug or its excipients.
* Participated in clinical trials of hepatitis B core protein allosteric regulators.
* The subject has participated in a clinical trial and received the investigational drug during the period prior to the first administration of the study: 5 half-lives or twice the duration of the biological effect of the study treatment or 90 days (if the half-life or duration is unknown).
* History or status of cardiovascular disease: history of risk factors for tip torsion ventricular tachycardia, including unexplained syncope, known long QT syndrome, heart failure, myocardial infarction, angina, or clinically significant abnormal laboratory tests. Family history of long QT syndrome or Brugada syndrome. The Electrocardiogram (ECG) showed clinically significant abnormalities. Heart Rate (HR)≤45 bpm.
* Those that researchers believe should not be included.

Where this trial is running

Beijing, Beijing and 20 other locations

• Beijing Ditan Hospital Capital Medical University — Beijing, Beijing, China (Not_yet_recruiting)
• Beijing Youan Hospital, Capital Medical Universitybeijing Institute of Hepatology — Beijing, Beijing, China (Not_yet_recruiting)
• Meng Chao Hepatobiliary Hospital of Fujian Medical University — Fuzhou, Fujian, China (Not_yet_recruiting)
• Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (Not_yet_recruiting)
• Guizhou Provincial People's Hospital — Guiyang, Guizhou, China (Not_yet_recruiting)
• Zunyi Medical University Affiliated Hospital — Zunyi, Guizhou, China (Not_yet_recruiting)
• Zhengzhou No.6 peoples Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• The Second XIANGYA Hospital Of Central South University — Changsha, Hunan, China (Not_yet_recruiting)
• Yueyang Central Hospital — Yueyang, Hunan, China (Not_yet_recruiting)
• Jiangsu Provincial People's Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• The Fifth People's Hospital of Suzhou — Suzhou, Jiangsu, China (Not_yet_recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
• The sixth people's Hospital Of Shenyang — Shenyang, Liaoning, China (Not_yet_recruiting)
• Shandong Public Health Clinical Center — Jinan, Shandong, China (Not_yet_recruiting)
• Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai, China (Recruiting)
• Shanghai Pudong Hospital — Shanghai, Shanghai, China (Not_yet_recruiting)
• Shanghai Pudong New District Gongli Hospital — Shanghai, Shanghai, China (Not_yet_recruiting)
• Shanghai Tongren Hospital — Shanghai, Shanghai, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xi'an Jiao Tong University — Xi'an, Shanxi, China (Not_yet_recruiting)
• The First Affiliated Hospital Zhejiang University School Of Medicine — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• Lishui People's Hospital — Lishui, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Qing Xie, Doctor

Conditions HBV Infection With LLV