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)

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.40 sites in 1 country122 target enrollmentNovember 14, 2024

ConditionsHBV Infection With LLV

InterventionsTQA3605 Placebo plus NAs TQA3605 tablets plus NAs

Overview

Phase: Phase 2
Intervention: TQA3605 Placebo plus NAs
Conditions: HBV Infection With LLV
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Enrollment: 122
Locations: 40
Primary Endpoint: HBV DNA (Hepatitis B virus Deoxyribonucleic Acid)
Status: Completed
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 14, 2024

End Date

December 10, 2025

Last Updated

3 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

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, 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.;

Arms & Interventions

TQA3605 Placebo plus NAs

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

Intervention: TQA3605 Placebo plus NAs

100mg TQA3605 tablets plus NAs

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

Intervention: TQA3605 tablets plus NAs

200mg TQA3605 tablets plus NAs

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

Intervention: TQA3605 tablets plus NAs

Outcomes

Primary Outcomes

HBV DNA (Hepatitis B virus Deoxyribonucleic Acid)

Time Frame: 24 weeks

Percentage of subjects with HBV DNA below the lower limit of quantitative detection (\<10 IU/mL) at 24 weeks of treatment

Secondary Outcomes

Incidence and severity of Adverse events (AEs)(32 weeks)
Incidence and severity of serious adverse events (SAEs)(32 weeks)
HBV DNA (<10 IU/mL)(Weeks 12, Weeks 16, Weeks 24, Weeks 28, Weeks 32)
Hepatitis B e antigen (HBeAg) Serology(Weeks 12, Weeks 24, Weeks 32)
Alanine Aminotransferase (ALT) relapse rate(Weeks 12, Weeks 24, Weeks 32)
Breakthroughs in virology(Weeks 12, Weeks 24, Weeks 32)
Actual values and changes of HbsAg (Hepatitis B Surface Antigen)(Weeks 12, Weeks 24, Weeks 32)
Actual values and changes of HBeAg(Weeks 12, Weeks 24, Weeks 32)
Actual values and changes of HBV DNA(Weeks 12, Weeks 24, Weeks 32)
HBV RNA (Hepatitis B virus Ribonucleic Acid)(Weeks 12, Weeks 24, Weeks 32)
Actual values and changes of Human Hepatitis B virus core antigen - associated antigen (HbcrAg)(Weeks 12, Weeks 24, Weeks 32)
(Cmax, ss) Steady-state maximum concentration(Day 1, Day 29, Day 57, Day 85, Day 113, Day 169)
(Cmin, ss) Steady state minimum concentration(Day 1, Day 29, Day 57, Day 85, Day 113, Day 169)
HBV DNA (<10 IU/mL)(Weeks 12, Weeks 16, Weeks 28, Weeks 32)