Evaluating TQA3810 Tablets for Chronic Hepatitis B Treatment

Randomized, Double-blind, Placebo-controlled Phase IIa Trial to Evaluate the Efficacy and Safety of Combined/Uncombined Nucleoside (Acid) Analogues of TQA3810 Tablets in Primary/Treated Patients With Chronic Hepatitis B

This study is testing if TQA3810 tablets can help people with chronic hepatitis B feel better, both alone and with other medications.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (industry)
• Locations: 6 sites (Wuwei, Gansu and 5 other locations)
• Trial ID: NCT06566248 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of TQA3810 tablets, both in combination with and without nucleoside analogues, in patients suffering from chronic hepatitis B. Participants will be evaluated based on their response to the treatment over a specified period. The study will include individuals who have been diagnosed with chronic hepatitis B and have been on stable nucleoside therapy for at least six months. The trial will monitor various health parameters to determine the effectiveness of the treatment regimen.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with chronic hepatitis B who have been on stable nucleoside therapy for at least six months.

Not a fit: Patients with obvious cirrhosis or those who do not meet the serum virological criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for managing chronic hepatitis B.

How similar studies have performed: While there have been studies on nucleoside analogues for hepatitis B, the specific combination with TQA3810 is a novel approach that has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Age 18-70 (including boundary values), male or female.
* Serum virological criteria: serum HBsAg positive for more than 6 months or evidence of chronic hepatitis B for more than 6 months. During the screening period, 100 IU/ml≤HBsAg quantification ≤10000 IU/ml.
* No obvious cirrhosis was found by the researchers.
* The subjects can communicate well with the researchers, understand and comply with the requirements of this study, and understand and sign the informed consent.
* The 12-lead electrocardiogram was normal, or there were no clinically significant abnormal values as assessed by the investigator.

Treated patients must meet the following conditions:

* Subjects must have received oral nucleoside (acid) therapy (entecavir/ Tenofovir alafenamide Fumarate tablets/Tenofovir Disoproxil Fumarate Tablets) for ≥6 months prior to screening and stable treatment regimen for ≥3 months prior to screening.
* Patients with medical history 6 months or more before enrollment had HBV DNA\< the lower limit of normal detection, and hepatitis B virus (HBV) DNA\<20 IU/mL was detected by Roche COBAS Taqman during the screening period.

Newly treated patients need to meet the following conditions:

* At the time of screening, subjects had never received antiviral treatment for chronic hepatitis B (oral nucleoside drugs and interferon), or had received irregular antiviral treatment in the past, and had not received any antiviral treatment for chronic hepatitis B in the first 3 months of enrollment.
* HBV DNA≥2000 IU/mL(Roche COBAS Taqman).

Exclusion Criteria:

* Combined with other viral infections such as hepatitis A virus，hepatitis C virus, hepatitis D virus, hepatitis E virus, human immunodeficiency virus，syphilis (syphilis antibody positive by the researchers to determine the need for treatment). If hepatitis C virus (HCV) antibody positive, HCV RNA negative can not be excluded.
* Patients with significant fibrosis or cirrhosis before or at the time of screening: liver histopathological findings indicating Metavir F3 or F4 within 1 year before screening; FibroScan≥ 9.7 kPa 6 months before screening in treated patients and ≥ 12.4 kPa 6 months before screening in newly treated patients; Abdominal ultrasonography suggested suspected cirrhosis. Previous history of hepatic decompensation or screening period of hepatic decompensation, such as ascites, hepatic encephalopathy, esophageal and gastric varices bleeding, etc.
* Patients with a history of hepatocellular carcinoma (HCC) before or at the time of screening, or who may be at risk for HCC, such as suspicious nodules on imaging, or abnormal AFP (AFP\>50ng/mL), should be excluded from HCC before enlisting.
* A history of malignant tumors within 5 years prior to screening, except for certain cancers that can be completely cured by surgical resection (such as skin basal cell carcinoma). Subjects being evaluated for active or suspected malignancy at the time of screening.
* Patients with other chronic liver diseases, including but not limited to autoimmune liver disease, alcoholic liver disease, hepatolenticular degeneration, etc.
* Have previously received organ transplantation and bone marrow transplantation.
* Patients with uncontrolled thyroid disease.
* Eye diseases: including fundus lesions (cotton wool changes in the fundus with symptoms) and retinopathy.
* Autoimmune diseases include but are not limited to: systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, sarcoidosis, psoriasis, autoimmune uveitis, etc.
* Current alcohol and drug abuse was determined by the investigator. Subjects with a history of excessive alcohol use. A history of excessive alcohol use was defined as alcohol consumption \>210g per week for men and \>140g for women in the past 12 months. Alcohol intake (g) = amount of alcohol consumed (ml) × alcohol degree % × 0.8.
* Blood transfusion ≤2 months before screening and/or blood donation ≤1 month before screening. Note: Subjects were not allowed to donate blood throughout the study period.
* Have a history of allergy to the experimental drug or its excipients;
* Female subjects are pregnant, breastfeeding or have positive pregnancy results during the screening period or during the test;
* Those that researchers believe should not be included.

Where this trial is running

Wuwei, Gansu and 5 other locations

• Gansu Wuwei Tumour Hospital — Wuwei, Gansu, China (NOT_YET_RECRUITING)
• Zunyi Medical University Affiliated Hospital — Zunyi, Guizhou, China (NOT_YET_RECRUITING)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (NOT_YET_RECRUITING)
• The Fifth People's Hospital of Suzhou — Suzhou, Jiangsu, China (NOT_YET_RECRUITING)
• Shenyang Sixth People's Hospital — Shenyang, Liaoning, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Xi 'an Jiaotong University — Xi'an, Shaanxi, China (RECRUITING)

Study contacts

• Study coordinator: Yanyan Yu, Doctor

Conditions: Chronic Hepatitis B