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Clinical Trial of TQA3605 Tablet in Combination With Nucleos(t)Ide Analogues(NAs) Versus NAs Alone for the Treatment of Patients With Chronic Hepatitis B Virus Infection Who Have Undergone Treatment and Exhibit Low Viral Load or Poor Response

A legfontosabb adatok

Ki végzi
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Hol
Anyang, Baoji, Beijing, Changchun, Changsha, Changzhi, Chengdu, Chifeng, Chongqing, Dalian, Deyang, Foshan, Fuzhou, Guangzhou, Guiyang, Haikou, Hangzhou, Harbin, Hefei, Hengyang, Huaihua, Jinan, Jingzhou, Kunming, Langfang, Lanzhou, Liaocheng, Lishui, Liuzhou, Luoyang, Lüliang, Meishan, Mudanjiang, Nanchang, Nanjing, Ningbo, Puyang, Qingdao, Shanghai, Shenzhen, Shenyang, Shijiazhuang, Suzhou, Taiyuan, Taizhou, Tianjin, Ürümqi, Weifang, Wenzhou, Wuhu, Wuwei, Xi'an, Xi’an, Xiamen, Xining, Yuncheng, Zhengzhou, Zhuhai és Zunyi (Kína)Mind a 77 helyszín megnézése
Azonosító
Állapot
Toborzás még nem indult
Fázis
3. fázis
Résztvevők
930 fő, tervezett
Kezdés
2026. szept.
Várható befejezés
2029. okt.
A vizsgálat típusa
Beavatkozással járó, 2 csoportAz egyik csoport placebót (hatóanyag nélküli szert) kap, összehasonlításként.
A vizsgált kezelések
  • TQA3605 tablets Placebo
  • TQA3605 tablets
  • Entecavir dispersible tablets
  • Tenofovir Disoproxil Fumarate Tablets
  • Tenofovir Alafenamide Fumarate Tablets
  • Tenofovir Amibufenamide Tablets
A regiszteradat frissítve
2026. október 2.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat 18 és 65 év közötti, krónikus hepatitisz B-vel élő felnőtteket keres, akik legalább 12 hónapja szednek nukleozid/nukleotid analóg gyógyszert, de a vírus még kimutatható náluk.

Életkor
18 és 65 év között
Nem
Mindkét nem csatlakozhat.
A betegség stádiuma
Több mint 1 éve fennálló krónikus hepatitisz B, 50 IU/mL feletti HBV DNS-sel és pozitív HBeAg-vel. Májzsugorodás vagy májrák esetén nem lehet csatlakozni.
Korábbi kezelés
Legalább 12 hónapos folyamatos nukleozid/nukleotid analóg kezelés (entecavir, tenofovir disoproxil fumarát, tenofovir alafenamid fumarát vagy tenofovir amibufenamid), legalább 6 hónapja változatlan gyógyszerrel.
Biomarker vagy leletérték
50 IU/mL feletti HBV DNS és pozitív HBeAg, mindkettőt a központi laboratórium igazolja.

A részvétel fő kizáró okai

  • Terhes vagy szoptató nők
  • Más vírusokkal való fertőzés, például HAV, HCV, HDV, HEV, HIV vagy szifilisz
  • Májzsugorodás vagy hepatocelluláris karcinóma a kórtörténetben
  • Más krónikus májbetegség vagy autoimmun betegség
  • Korábbi részvétel hepatitisz B core fehérje allosztérikus modulátorokkal (CpAM) végzett vizsgálatban

A regiszter feltételei, szó szerint

Mind a 26 feltétel megnézéseKevesebb

Ki vehet részt

  • Male or female participants aged 18-65 years (inclusive) at screening
  • Able to communicate effectively with the investigator, understand and comply with all requirements of this study, and understand and sign the informed consent form
  • Have received continuous treatment with nucleos(t)ide analogues (entecavir, tenofovir disoproxil fumarate, tenofovir alafenamide fumarate or tenofovir amibufenamide) or NAs combination therapy for ≥ 12 months at screening, with a stable single regimen for ≥ 6 months (medication adherence > 90% in the past 12 months, with no treatment interruption exceeding 15 consecutive days)
  • Etiological evidence is available at screening to confirm chronic HBV infection of more than 1 year (HBsAg positive and/or HBV DNA positive for at least 1 year)
  • HBV DNA > 50 IU/mL detected by a local medical institution within 30 days prior to screening, which is reconfirmed as HBV DNA > 50 IU/mL by the central laboratory during the screening period
  • HBeAg positive as confirmed by the central laboratory at screening
  • Male trial participants with fertile female partners or female participants of childbearing potential are willing to use effective contraception from screening until 3 months after study discontinuation

Ki nem vehet részt

  • History of liver cirrhosis; or liver histopathology obtained within 1 year prior to screening indicating Metavir ≥ S3, Scheuer ≥ S3 or Ishak ≥ S4; or FibroScan result ≥ 9.0 kPa within 6 months prior to screening; or previous endoscopy revealing esophageal and gastric varices; or suspected liver cirrhosis identified on abdominal ultrasonography at screening, such as ascites, hepatic encephalopathy, and bleeding from esophageal and gastric varices
  • History of hepatocellular carcinoma (HCC) or suspected HCC at or prior to screening (e.g., suspicious lesions on imaging, or AFP ≥ 50 ng/mL)
  • Major trauma or major surgery within 3 months prior to screening, or planned surgery during the study period
  • Received any systemic anti-tumor therapy (including radiotherapy), immunosuppressive therapy (including biological immunosuppressants), or immunomodulatory therapy within 6 months prior to screening (including oral non-biological immunomodulatory agents such as methotrexate greater than 25 mg/week, azathioprine greater than 3 mg/kg/day, or 6-mercaptopurine greater than 1.5 mg/kg/day)
  • Received high-dose systemic corticosteroids within 3 months prior to screening, defined as prednisone ≥ 40 mg/day for more than 7 consecutive days or prednisone ≥ 20 mg/day for more than 14 consecutive days
  • History of allergy to the investigational product or its excipients
  • Previous participation in clinical trials of hepatitis B core protein allosteric modulators (CpAMs)
  • Participated in other clinical trials of investigational drugs or medical devices and received study intervention within 3 months prior to screening
  • Co-infection with other viruses such as HAV, HCV, HDV, HEV, HIV, or syphilis (participants with positive syphilis antibody who require treatment as judged by the investigator; Participants with positive HCV antibody and negative HCV RNA may not be excluded)
  • History of malignant tumor within 5 years prior to screening, except for certain malignancies that are completely curable after surgical resection (e.g., basal cell carcinoma of the skin). Trial participants under evaluation for active or suspected malignant tumor at screening
  • Trial participants with other chronic liver diseases, including but not limited to autoimmune liver disease, alcoholic liver disease, Wilson's disease, metabolic dysfunction-associated steatohepatitis (MASH)
  • Autoimmune diseases including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, sarcoidosis, psoriasis, autoimmune uveitis
  • History of drug dependence or substance abuse
  • History of excessive alcohol consumption. Excessive alcohol consumption is defined as weekly ethanol intake exceeding 210 g for males and 140 g for females over the past 12 months. Ethanol intake (g) = Volume consumed (mL) × Alcohol by volume (%) × 0.8
  • Clinically significant abnormal laboratory parameters at screening (abnormal values may be retested once): Hematology: white blood cell count less than 3 ×10⁹/L, neutrophil count less than 1.5 ×10⁹/L, platelet count less than 100 ×10⁹/L, or hemoglobin less than 100 g/L. Biochemistry: estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI formula ≤ 60 mL/min/1.73 m²; ALT or AST greater than 3 × ULN; total bilirubin greater than 2 × ULN; albumin less than 30 g/L; total cholesterol ≥ 7.75 mmol/L; triglycerides ≥ 3.42 mmol/L; serum uric acid greater than 420 μmol/L. Coagulation: international normalized ratio (INR) greater than 1.5.4) Antinuclear antibody (ANA) greater than 1:100 (indirect immunofluorescence, IIF). If ANA = 1:100, the investigator shall assess whether there is relevant medical history or symptoms of connective tissue disease or autoimmune disease
  • Significant systemic or severe diseases other than liver disease, including recent (≤ 6 months prior to screening) congestive heart failure (New York Heart Association (NYHA) Functional Classification III-IV), unstable coronary artery disease, arterial revascularization, respiratory diseases, renal insufficiency, stroke, transient ischemic attack, organ transplantation, psychiatric disorders. Uncontrolled systemic diseases: poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg); poorly controlled diabetes (fasting plasma glucose (FPG) greater than 10 mmol/L)
  • Pregnant women (positive pregnancy test) or breastfeeding women
  • Electrocardiogram showing clinically significant abnormalities at screening rendering the participant unsuitable for trial participation as judged by the investigator
  • Participants deemed inappropriate for enrollment by the investigator

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

  • 18 és 65 év között vagy?

Helyszínek itt: Kína

  • Anyang People's HospitalAnyang, KínaContact: fangjie chen, BachelorNo longer taking part
  • Bao Ji City People's Hospital （BaoJi Emergency Medical Center ）Baoji, KínaContact: Fuchun Jing, DoctorNo longer taking part
  • Beijing Ditan Hospital, Capital Medical UniversityBeijing, KínaContact: Minghui li, doctorNo longer taking part
  • Beijing YouAn Hospital,Capital Medical UniversityBeijing, KínaContact: Bin Xu, doctorNo longer taking part
  • Peking University First HospitalBeijing, KínaContact: Jinghang Xu, DoctorNo longer taking part
  • Hepatobiliary Hospital of Jilin ProvinceChangchun, KínaContact: shurong liu, Bachelor's DegreeNo longer taking part
  • The First Hospital of Jilin UniversityChangchun, KínaContact: Junqi Niu, doctorNo longer taking part
  • The Second Hospital of Jilin UniversityChangchun, KínaContact: Zhenjing Jin, DoctorNo longer taking part
  • Second Xiangya Hospital of Central South UniversityChangsha, KínaContact: Yongfang Jiang, doctorNo longer taking part
  • Changzhi People's HospitalChangzhi, KínaContact: Hong WU, MasterNo longer taking part
  • Public Health Clinical Center of ChengduChengdu, KínaContact: Li Zhu, bechelorNo longer taking part
  • Sichuan Academy of Medical Sciences sichuan Provincial People's HospitalChengdu, KínaContact: Jianmei Lin, masterNo longer taking part
  • Chifeng HospitalChifeng, KínaContact: huidong lu, MasterNo longer taking part
  • Chongqing University Three Gorges HospitalChongqing, KínaContact: Guicheng Wu, DoctorNo longer taking part
  • The Second Affiliated Hospital of Chongqing Medical UniversityChongqing, KínaContact: peng hu, doctorNo longer taking part
  • The Southwest hospital of AMUChongqing, KínaContact: qing mao, doctorNo longer taking part
  • Dalian Public Health Clinical CenterDalian, KínaContact: gongchen wang, doctorNo longer taking part
  • Deyang People's HospitalDeyang, KínaContact: Xuebing chen, MasterNo longer taking part
  • Nanhai District People's Hospital of FoshanFoshan, KínaContact: yongchun Li, doctorNo longer taking part
  • Mengchao Hepatobiliary Hospital of Fujian Medical UniversityFuzhou, KínaContact: Haibing Gao, DoctorNo longer taking part
  • The Third Affiliated Hospital of Sun Yat-Sen UniversityGuangzhou, KínaContact: Liang Peng, DoctorNo longer taking part
  • Guizhou Provincial People's HospitalGuiyang, KínaContact: Hong Peng, DoctorNo longer taking part
  • Hainan Provincial People's HospitalHaikou, KínaContact: Jian Fu, Bachelor's DegreeNo longer taking part
  • The First Affiliated Hospital Zhejiang University School of MedicineHangzhou, KínaContact: Yida Yang, doctorNo longer taking part
  • Harbin Medical University, The Second Affiliated HospitalHarbin, KínaContact: Ming Liang, DoctorNo longer taking part
  • The Fourth Hospital of Harbin Medical UniversityHarbin, KínaContact: lei yu, doctorNo longer taking part
  • The First Affiliated Hospital of Anhui Medical UniversityHefei, KínaContact: YuFeng Gao, doctorNo longer taking part
  • The First Affiliated Hospital of USTC(Anhui Provincial Hospital)Hefei, KínaContact: HongLiang HE, doctorNo longer taking part
  • The First Affiliated Hospital of University of South ChinaHengyang, KínaContact: Zhongtian Peng, MasterNo longer taking part
  • The General Hospital of Hunan University of MedicineHuaihua, KínaContact: YongZhong Li, Bachelor's DegreeNo longer taking part
  • Shandong Public Health Clinical CenterJinan, KínaContact: Xiaoying Li, MasterNo longer taking part
  • Jingzhou Central HospitalJingzhou, KínaContact: Qin Ming Hu, Bachelor of MedicineNo longer taking part
  • The First Affiliated Hospital of Kunming Medical UniversityKunming, KínaContact: Jinghua Fan, DoctorNo longer taking part
  • Hebei Petro China Central HospitalLangfang, KínaContact: Meili GAO, BachelorNo longer taking part
  • The First Hospital of Lanzhou UniversityLanzhou, KínaContact: Liting Zhang, doctorNo longer taking part
  • Liaocheng People's HospitalLiaocheng, KínaContact: Fenghua Liu, MasterNo longer taking part
  • Lishui People's HospitalLishui, KínaContact: Jiaojian Lv, bachelorNo longer taking part
  • Liuzhou Worker's HospitalLiuzhou, KínaContact: Qian GUO, MasterNo longer taking part
  • Luoyang Central Hospital（Luoyang Central Hospital Affiliated to Zhengzhou University）Luoyang, KínaContact: Guotao Li, MasterNo longer taking part
  • Shanxi province fenyang hospitalLüliang, KínaContact: YaoWu Zhang, MasterNo longer taking part
  • Meishan People's HospitalMeishan, KínaContact: Hui Deng, BachelorNo longer taking part
  • Mudanjiang Kang'an HospitalMudanjiang, KínaContact: Xiqiu Zeng, masterNo longer taking part
  • The First Affiliated Hospital of NanChang UniversityNanchang, KínaContact: Xiaoping Wu, DoctorNo longer taking part
  • The Second Affiliated Hospital of Nanchang UniversityNanchang, KínaContact: shuilin Sun, MasterNo longer taking part
  • Jiangsu Province HospitalNanjing, KínaContact: Li Dong, DoctorNo longer taking part
  • Nanjing Drum Tower hospitalNanjing, KínaContact: Jie Li, doctorNo longer taking part
  • The Second Hospital of NingboNingbo, KínaContact: yunsong Qian, Bachelor's degreeNo longer taking part
  • Puyang People's HospitalPuyang, KínaContact: wenjing Dou, MasterNo longer taking part
  • QingDao Municipal HospitalQingdao, KínaContact: Yongning Xin, doctorNo longer taking part
  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of MedicineShanghai, KínaContact: Qing Xie, doctorNo longer taking part
  • Shanghai East HospitalShanghai, KínaContact: LiHong Qu, doctorNo longer taking part
  • Shanghai Pudong HospitalShanghai, KínaContact: Wujun Xiong, DoctorNo longer taking part
  • Shanghai Pudong New Area Gongli HospitalShanghai, KínaContact: Shi Yi Hai, doctorNo longer taking part
  • Shanghai Sixth People's HospitalShanghai, KínaContact: XiaoHua Chen, doctorNo longer taking part
  • Peking University Shenzhen HospitalShenzhen, KínaContact: Guoxin Hu, Doctor of MedicineNo longer taking part
  • Shengjing Hospital Of China Medical UniversityShenyang, KínaContact: yang ding, doctorNo longer taking part
  • The Sixth People's Hospital of ShenyangShenyang, KínaContact: xiaofeng wu, MasterNo longer taking part
  • Shijiazhuang Fifth HospitalShijiazhuang, KínaContact: Wenfang Yuan, BachelorNo longer taking part
  • The Fifth People's Hospital of SuzhouSuzhou, KínaContact: Chuanwu Zhu, DoctorNo longer taking part
  • Shanxi Provincial People's HospitalTaiyuan, KínaContact: Jing Feng, DoctorNo longer taking part
  • Taizhou Hospital of Zhejiang ProvinceTaizhou, KínaContact: Jiansheng Zhu, MasterNo longer taking part
  • Tianjin First Central HospitalTianjin, KínaContact: fengmei wang, doctorNo longer taking part
  • The First Affiliated Hospital of Xinjiang Medical UniversityÜrümqi, KínaContact: Xiaobo lu, doctorNo longer taking part
  • The Fourth Affiliated Hospital of Xinjiang Medical University (Traditional Chinese Medical Hospital of Xinjiang Uygur Autonomous Region)Ürümqi, KínaContact: xiaozhong wang, Master degreeNo longer taking part
  • Weifang People's HospitalWeifang, KínaContact: Jianhong Chen, MasterNo longer taking part
  • Ruian People's HospitalWenzhou, KínaContact: Liang Hong, bachelorNo longer taking part
  • The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)Wuhu, KínaContact: Jianghua Yang, DoctorNo longer taking part
  • Gansu Wuwei Tumour HospitalWuwei, KínaContact: Wenhua Zhang, BachelorNo longer taking part
  • The Second Affiliated Hospital of Xi'an Jiaotong UniversityXi'an, KínaContact: Shuangsuo Dang, DoctorNo longer taking part
  • The First Affiliated Hospital of Xi'an Jiao Tong UniversityXi’an, KínaContact: Yingli He, DoctorNo longer taking part
  • Zhongshan Hospital Xiamen UniversityXiamen, KínaContact: Hongzhi Xu, DoctorNo longer taking part
  • The 4'th People's Hospital of Qinghai ProvinceXining, KínaContact: Hongmei Zu, doctorNo longer taking part
  • Yuncheng Central HospitalYuncheng, KínaContact: Lijun Chang, Master of medicineNo longer taking part
  • The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, KínaContact: Juan li, DoctorNo longer taking part
  • The Sixth People's Hospital of ZhengzhouZhengzhou, KínaContact: Guangming Li, masterNo longer taking part
  • The Fifth Affiliated Hospital of Sun Yat-sen UniversityZhuhai, KínaContact: Zhongsi Hong, MasterNo longer taking part
  • Affiliated Hospital of Zunyi Medical UniversityZunyi, KínaContact: yu yi, MasterNo longer taking part

A vizsgálatról

Mit akar kideríteni a vizsgálat

This is a multicenter, randomized, double-blind, placebo-controlled Phase III study with an open-label extension. The purpose is to evaluate efficacy and safety in adult patients with chronic hepatitis B virus infection who have received at least 12 months of NAs therapy, to demonstrate that TQA3605 Tablets combined with oral nucleos(t)ide analogues can improve efficacy with satisfactory safety profile compared with oral nucleos(t)ide analogues alone in this population. Approximately 930 adult patients with chronic hepatitis B virus infection who have received at least 12 months of NAs therapy are planned to be enrolled in this study.

A vizsgálat 2 csoportja

  • TQA3605 Tablets + NAsA vizsgált kezelés

    TQA3605 Tablets 100 mg once daily (QD) plus NAs administered for 96 weeks. Following completion of the 96-week treatment period, participants will continue NAs therapy with an 8-week follow-up.

    Kezelés: TQA3605 tablets, Entecavir dispersible tablets, Tenofovir Disoproxil Fumarate Tablets, Tenofovir Alafenamide Fumarate Tablets és Tenofovir Amibufenamide Tablets

  • TQA3605 Tablets Placebo + NAsPlacebo, összehasonlításként

    TQA3605 tablets placebo, once daily, combined with NAs for 48 weeks. After the 48-week double-blind period, all trial participants received TQA3605 tablets, 100mg each time, QD, combined with NAs for another 48 weeks. After the 96-week treatment, NAs treatment was continued for an 8-week follow-up

    Kezelés: TQA3605 tablets Placebo, TQA3605 tablets, Entecavir dispersible tablets, Tenofovir Disoproxil Fumarate Tablets, Tenofovir Alafenamide Fumarate Tablets és Tenofovir Amibufenamide Tablets

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
A Randomized, Double-Blind, Placebo-Controlled Phase III Trial With an Open-Label Extension to Evaluate the Efficacy and Safety of TQA3605 Tablets in Chronic Hepatitis B Virus-Infected Patients With Low-Level Viremia or Suboptimal Response After at Least 12 Months of NAs Therapy
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 13.
Illeszkedési kérdések
Forrás: NCT07797231: ki vehet részt
A regiszteradat frissítve
2026. október 2.