Clinical Study of TQA3605 Tablets Combined With Nucleoside (Acid) Analogs (NAs) Drugs Compared With NAs Drugs in the Treatment of Chronic Hepatitis B Virus (HBV) Infection

CTTQ

Status and phase: Completed; Phase 2

Conditions: HBV Infection With LLV

Treatments: Drug: TQA3605 Placebo plus NAs; Drug: TQA3605 tablets plus NAs

Study type: Interventional

Funder types: Industry

Identifiers

NCT06644417

TQA3605-II-01

Details and patient eligibility

About

This study is a phase II multicenter, randomized, double-blind, placebo controlled study designed to evaluate the efficacy and safety in LLV subjects and demonstrate that TQA3605 tablets combined with oral NAs drugs can improve the efficacy and safety of LLV subjects compared with oral NAs drug.

Enrollment: 122 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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, 10 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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122 participants in 3 patient groups, including a placebo group

TQA3605 Placebo plus NAs

Placebo Comparator group

Description:

TQA3605 placebo plus NAs drug was administered for 24 weeks and NAs was continued until 32 weeks

Treatment:

Drug: TQA3605 Placebo plus NAs

100mg TQA3605 tablets plus NAs

Experimental group

Description:

100mg TQA3605 tablets plus NAs drug was administered for 24 weeks and NAs was continued until 32 weeks

Treatment:

Drug: TQA3605 tablets plus NAs

200mg TQA3605 tablets plus NAs

Experimental group

Description:

200mg TQA3605 tablets plus NAs drug was administered for 24 weeks and NAs was continued until 32 weeks

Treatment:

Drug: TQA3605 tablets plus NAs