A Clinical Study of TQA3605 Tablets Monotherapy or in Combination With Nucleoside (Acid) Analogues in Treatment Naive and Treated Patients With Chronic Hepatitis B

CTTQ

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Chronic Hepatitis b

Treatments: Drug: TQA3605 tablets; Drug: Entecavir dispersible tablets; Drug: Tenofovir disoproxil fumarate tablet; Drug: Placebo; Drug: Tenofovir alafenamide fumarate tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT06150014

TQA3605-Ib/IIa-01

Details and patient eligibility

About

A randomized, double-blind Phase Ib/IIa multicenter trial design was used. All eligible subjects received TQA3605 tablets/placebo plus nucleoside (acid) analogues. A total of 88 subjects were required

Enrollment: 88 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects voluntarily participate in this study and sign informed consent;
• Male and female, ≥18 years old and ≤70 years old (subject to the date of signing the informed consent);
• Patients diagnosed with chronic hepatitis B (CHB) who have been serum HBsAg positive for more than 6 months and HBeAg positive or negative ;
• The liver fibrosis ultrasound transient imaging elastic technology (Fibroscan/FibroTouch) showed that the liver hardness (LSM) was less than 12.4 Kpa;
• Patients with chronic hepatitis B after treatment;
• Treatment-naïve patients of chronic hepatitis B patients;

Exclusion criteria

• Complicated with other infected disease such as hepatitis A virus (HAV), hepatitis C virus (HCV), Hepatitis D virus (HDV), hepatitis E virus (HEV), human immunodeficiency virus (HIV), syphilis (syphilis antibody positive and need treatment determined by the investigator);
• Abdominal ultrasound or other imaging or histology showed suspected cirrhosis or other liver disease before or during screening;
• Patients have a history of hepatocellular carcinoma (HCC) before or at the time of screening, or may be at risk for HCC;
• Active autoimmune disease diagnosed with immunodeficiency or undergoing systemic therapy which was continuing within 2 weeks before first dosing;
• Currently being treated with nephrotoxic drugs or drugs that alter renal excretion;
• Abnormal thyroid function;
• Renal diseases such as chronic kidney disease and renal insufficiency or creatinine clearance (CLCr) <60 ml/min during the screening period;
• Hematologic and biochemical abnormalities;
• History of allergy to the investigational drug or its excipients;
• Recipients of solid organs or bone marrow transplants;
• A history of malignant tumors within the past 5 years;
• Interstitial lung disease, acute lung disease, etc.;
• Uncontrolled systemic diseases such as high blood pressure and diabetes;
• Have used any investigational drug or participated in a clinical trial within one month prior to the administration of study drug;
• Those who received live attenuated vaccine within 28 days before the start of study treatment, inactivated vaccine within 7 days, or planned vaccination during the study period;
• The investigator determines that there is any medical or psychiatric condition that puts the subject at risk, interferes with participation in the study, or interferes with the interpretation of the study results;
• Female subjects that were pregnant, lactating or had a positive pregnancy result during the screening period or during the trial; Male and female patients with reproductive potential who were unwilling to use effective contraceptive methods during the study period;
• Subjects who have any medical condition that may affect the absorption of oral drugs;
• Within 12 weeks prior to screening, treated chronic hepatitis B patients who had stopped taking nucleoside (acid) analogues for more than 14 consecutive days;
• Those considered unsuitable for enrollment by the investigators.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

88 participants in 8 patient groups, including a placebo group

Placebo +Nucleoside (acid) analogs (NAs) combination therapy 24 weeks

Placebo Comparator group

Description:

Placebo and Nucleoside (acid) analogues, taken orally once daily, continue for 24 weeks.

Treatment:

Drug: Tenofovir alafenamide fumarate tablet

Drug: Placebo

Drug: Tenofovir disoproxil fumarate tablet

Drug: Entecavir dispersible tablets

50 mg of TQA3605 tablets +NAs combination therapy 24 weeks

Active Comparator group

Description:

50 mg of TQA3605 tablets and Nucleoside (acid) analogues, taken orally once daily, continue for 24 weeks.

Treatment:

Drug: Tenofovir alafenamide fumarate tablet

Drug: Tenofovir disoproxil fumarate tablet

Drug: Entecavir dispersible tablets

Drug: TQA3605 tablets

100 mg of TQA3605 tablets +NAs combination therapy 48 weeks

Active Comparator group

Description:

TQA3605 is taken orally 100mg once daily; Nucleoside (acid) analogues were used once daily for 48 weeks.

Treatment:

Drug: Tenofovir alafenamide fumarate tablet

Drug: Tenofovir disoproxil fumarate tablet

Drug: Entecavir dispersible tablets

Drug: TQA3605 tablets

200 mg of TQA3605 tablets +NAs combination therapy 48 weeks

Active Comparator group

Description:

TQA3605 is taken orally 200mg once daily; Nucleoside (acid) analogues were used once daily for 48 weeks.

Treatment:

Drug: Tenofovir alafenamide fumarate tablet

Drug: Tenofovir disoproxil fumarate tablet

Drug: Entecavir dispersible tablets

Drug: TQA3605 tablets

Placebo +Nucleoside (acid) analogs (NAs) combination therapy

Placebo Comparator group

Description:

Placebo taken orally once daily, continue for 12 weeks. Placebo was then combined with nucleoside (acid) analogues (once daily) for 36 weeks

Treatment:

Drug: Tenofovir alafenamide fumarate tablet

Drug: Placebo

Drug: Tenofovir disoproxil fumarate tablet

Drug: Entecavir dispersible tablets

100 mg of TQA3605 tablets +NAs combination therapy

Active Comparator group

Description:

TQA3605 was taken orally 100mg once a day for 12 weeks. It was then combined with nucleoside (acid) analogues (once daily) for 36 weeks.

Treatment:

Drug: Tenofovir alafenamide fumarate tablet

Drug: Tenofovir disoproxil fumarate tablet

Drug: Entecavir dispersible tablets

Drug: TQA3605 tablets

200 mg of TQA3605 tablets +NAs combination therapy

Active Comparator group

Description:

TQA3605 was taken orally 200mg once a day for 12 weeks. It was then combined with nucleoside (acid) analogues (once daily) for 36 weeks.

Treatment:

Drug: Tenofovir alafenamide fumarate tablet

Drug: Tenofovir disoproxil fumarate tablet

Drug: Entecavir dispersible tablets

Drug: TQA3605 tablets

300 mg of TQA3605 tablets+NAs combination therapy

Active Comparator group

Description:

TQA3605 was taken orally 300mg once a day for 12 weeks. It was then combined with nucleoside (acid) analogues (once daily) for 36 weeks.

Treatment:

Drug: Tenofovir alafenamide fumarate tablet

Drug: Tenofovir disoproxil fumarate tablet

Drug: Entecavir dispersible tablets

Drug: TQA3605 tablets