A Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive Chronic HBV-infected Subjects

CTTQ

Status and phase: Withdrawn; Phase 2

Conditions: Chronic Hepatitis B

Treatments: Drug: TQA3605 Tablets; Drug: Entecavir dispersible tablets; Drug: TQA3605 tablets Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06990776

TQA3605-II-02

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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;
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

0 participants in 5 patient groups, including a placebo group

100mg TQA3605 tablets + entecavir (ETV) (PART A)

Experimental group

Description:

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

Treatment:

Drug: Entecavir dispersible tablets

Drug: TQA3605 Tablets

200mg TQA3605 tablets +ETV (PART A)

Experimental group

Description:

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

Treatment:

Drug: Entecavir dispersible tablets

Drug: TQA3605 Tablets

TQA3605 tablets Placebo +ETV (PART A)

Placebo Comparator group

Description:

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.

Treatment:

Drug: TQA3605 tablets Placebo

200mg TQA3605 tablets +ETV (PART B)

Experimental group

Description:

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.

Treatment:

Drug: Entecavir dispersible tablets

Drug: TQA3605 Tablets

TQA3605 tablets Placebo +ETV (PART B)

Placebo Comparator group

Description:

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.

Treatment:

Drug: TQA3605 tablets Placebo