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

NCT06990776 — Phase 2, Withdrawn, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive HBeAg-positive Subjects With Chronic HBV Infection

RegistryNCT06990776
StatusWithdrawn - Per sponsor request. Premature closure was not prompted by any safety or efficacy concerns.
PhasePhase 2
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry)
ConditionsChronic Hepatitis B
InterventionsTQA3605 tablets Placebo, TQA3605 Tablets, Entecavir dispersible tablets (Drug)
Datesstart 2025-07-09, primary completion 2025-07-17, completion 2025-07-17, first posted 2025-05-25, last updated 2025-08-03
Locations29 sites in China

Related Papers Related Patents Related Grants Related Experts
All trials for Chronic Hepatitis B All trials of TQA3605 tablets Placebo All trials of TQA3605 Tablets

-Summary

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.

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+Arms and interventions

ArmTypeInterventionsDescription
100mg TQA3605 tablets + entecavir (ETV) (PART A)ExperimentalDrug: TQA3605 Tablets; Drug: Entecavir dispersible tabletsPatients 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
200mg TQA3605 tablets +ETV (PART A)ExperimentalDrug: TQA3605 Tablets; Drug: Entecavir dispersible tabletsPatients 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
TQA3605 tablets Placebo +ETV (PART A)Placebo comparatorDrug: TQA3605 tablets PlaceboPatients 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.
200mg TQA3605 tablets +ETV (PART B)ExperimentalDrug: TQA3605 Tablets; Drug: Entecavir dispersible tabletsPatients 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.
TQA3605 tablets Placebo +ETV (PART B)Placebo comparatorDrug: TQA3605 tablets PlaceboPatients 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.
  • TQA3605 tablets Placebo (Drug): Placebo contains no active substance.
  • TQA3605 Tablets (Drug): TQA3605 tablets is core protein allosteric modulators
  • Entecavir dispersible tablets (Drug): Entecavir dispersible tablets is an inhibitor of hepatitis B virus replication.

+Outcome measures

Primary outcomes

  • hepatitis B virus (HBV) DNA <10 IU/mL [48 weeks]: Percentage of subjects with HBV DNA below the lower limit of quantification (<10 IU/mL) after 48 weeks of treatment.

Secondary outcomes

  • Percentage of subjects with HBV DNA<10 IU/mL [12 weeks, 24 weeks, 36 weeks, 60 weeks, 72 weeks]: Percentage of subjects with HBV DNA<10 IU/mL at week 12, 24, 36, 60, and 72
  • Percentage of HBV DNA<20 IU/mL [12 weeks, 24 weeks, 36 weeks, 48weeks, 60 weeks, 72 weeks]: Percentage of subjects with HBV DNA<20 IU/mL at weeks 12, 24, 36, 48, 60, and 72 of treatment.
  • Percentage of subjects with HBeAg serologic clearance and/or serologic conversion [24weeks, 48 weeks, 72 weeks]: Percentage of subjects with HBeAg serologic clearance and/or serologic conversion
  • Alanine aminotransferase(ALT)≤The upper limit of the normal reference value (ULN) [24weeks, 48 weeks, 72 weeks]: The rate of ALT normalization at weeks 24, 48, and 72 of treatment
  • Virology breakthrough percentage [24weeks, 48 weeks, 72 weeks]: Percentage of subjects who experienced virological breakthroughs at weeks 24, 48, and 72 of treatment
  • Actual values of HBV markers and changes over time relative to baseline [12 weeks, 24 weeks, 36 weeks, 48 weeks, 72 weeks]: Actual values of HBsAg, HBeAg, HBV DNA, HBV RNA, and Hepatitis B core-related antigen (HBcrAg) at each visit time point and their changes over time relative to baseline.
  • Adverse events (AE) [72 weeks]: The incidence and severity of adverse events.
  • Steady state minimum concentration (Cmin,ss) [48 weeks]: Cmin,ss of TQA3605 and its metabolite

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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.

+Locations (29)

FacilityCityCountryStatus
Beijing Ditan Hospital Capital Medical UniversityBeijing, Beijing MunicipalityChina
Beijing Youan Hospital,Capital Medical UniversityBeijing, Beijing MunicipalityChina
The Second Affiliated Hospital of Chongqing Medical UniversityChongqing, Chongqing MunicipalityChina
The Southwest Hospital of AMUChongqing, Chongqing MunicipalityChina
Mengchao Hepatobiliary Hospital of Fujian Medical UniversityFuzhou, FujianChina
NanFang HospitalGuangzhou, GuangdongChina
Peking University Shenzhen HospitalShenzhen, GuangdongChina
The First Affiliated Hospital of GUANGXI Medical UniversityNanning, GuangxiChina
Hebei Medical University Third HospitalShijiazhuang, HebeiChina
Zhengzhou No.6 peoples HospitalZhengzhou, HenanChina
Henan Provincial People's HospitalZhengzhou, HenanChina
The First Hospital of ChangshaChangsha, HunanChina
Jiangsu Provincial People's HospitalNanjing, JiangsuChina
The Second Hospital of NanjingNanjing, JiangsuChina
Naniing Drum Tower HospitalNanjing, JiangsuChina
The Fifth People's Hospital of SuzhouSuzhou, JiangsuChina
The Fifth People's Hospital of WuxiWuxi, JiangsuChina
Zhenjiang Third People's HospitalZhenjiang, JiangsuChina
The First Affiliated Hospital of Nanchang UniversityNanchang, JiangxiChina
The First Hospital of Jilin UniversityChangchun, JilinChina
Shengjing Hospital Affiliated to China Medical UniversityShenyang, LiaoningChina
The First Affiliated Hospital of Xi'an Jiao Tong UniversityXi'an, ShaanxiChina
Xi'an Jiaotong University Second Affiliated HospitalXi'an, ShaanxiChina
The Second Hospital of Shandong UniversityJinan, ShandongChina
Shandong Provincial Clinical Center for Public HealthJinan, ShandongChina
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of MedicineShanghai, Shanghai MunicipalityChina
Shanghai Tongren HospitalShanghai, Shanghai MunicipalityChina
The First Affiliated Hospital of Xinjiang Medical UniversityÜrümqi, XinjiangChina
Yiwu Central HospitalYiwu, ZhejiangChina