A Clinical Study to Evaluate the Efficacy of TQA3038 Injection in Patients With Chronic Hepatitis B

Hepatitis B, Chronic Clinical Trial

Official title:

A Phase Ib/IIa Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic, and Antiviral Efficacy of TQA3038 Injection in Patients With Chronic Hepatitis B

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06452693
• Other study ID #: TQA3038-Ib/IIa-01
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: June 2024
• Est. completion date: September 2026

Study information

• Verified date: March 2024
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Qin Ning, Doctor
• Phone: 13971521450
• Email: qning[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is divided into two parts. Phase Ib is a randomized, double-blind, placebo-controlled trial, designed to evaluate the safety, tolerability, pharmacokinetic characteristics, preliminary efficacy, and immunogenicity of TQA3038 injection in patients with chronic hepatitis B. It is expected to include 72 subjects. Phase IIa adopted an open-label, randomized, parallel-controlled design, with a total of 90 subjects included, mainly evaluating the changes in serum HBsAg compared to baseline at the end of the 48th week.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 162
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subjects voluntarily participate in this study and sign informed consent;
• Male and female =18 years old and =65 years old;
• Male subjects with a weight of = 50 kilograms and female subjects with a weight of = 45 kilograms, BMI 18~28 kg/m2;
• Patients diagnosed with chronic hepatitis B (CHB) who have been serum HBsAg positive for more than 6 months and HBeAg positive ; During the screening period, 100 IU/ml = HBsAg quantification = 5000 IU/ml;
• The subjects are able to communicate well with the researchers, voluntarily and can understand and follow the experimental protocol process to complete the study;
• The subjects (including partners) are willing to voluntarily adopt effective contraceptive measures during the clinical trial period and long-term follow-up period, and specific contraceptive measures are shown in the appendix;
• The treated patients need to meet the condition:The subject must have received oral nucleoside (acid) drug treatment and a stable treatment regimen;
• Newly treated patients must meet the condition:During screening, the subjects had never received antiviral treatment for chronic hepatitis B B (oral nucleoside (acid) drugs and interferon), or had irregular antiviral treatment in the past, but had not received any antiviral treatment for chronic hepatitis B 3 months before enrollment.

Exclusion Criteria:

• Pregnant and lactating women;
• Chronic diseases other than chronic HBV infection with significant clinical significance that have a history of mental illness or are deemed unsuitable by researchers for participation in this study;
• Acute diseases with significant clinical significance occurring within 7 days prior to receiving the investigational drug;
• Individuals with a history of active pathological bleeding or a tendency towards bleeding;
• Prescription medication has been used within 14 days prior to receiving the study drug;
• Receive any preventive or attenuated vaccines within 14 days prior to receiving the study drug;
• Blood donors or those who have lost a significant amount of blood within the first 3 months of screening, or those who have donated blood during the planned study period;
• Subjects with a history of excessive alcohol consumption;
• A history of alcohol or drug abuse within the 12 months prior to screening, or a positive drug screening result during screening;
• Complicated with other infected disease;
• Patients with significant liver fibrosis or cirrhosis before or during screening;
• History of chronic liver diseases other than chronic HBV infection;
• Patients have a history of hepatocellular carcinoma (HCC) before or at the time of screening, or may be at risk for HCC;
• Used immunosuppressive or immunomodulatory drugs and cytotoxic drugs within 6 months prior to the study medication;
• During screening, subjects showed significant laboratory results abnormalities;
• Screening for tumors with a history of malignancy within the first 5 years, excluding tumors that can be completely cured through surgical resection;
• Uncontrollable chronic diseases;
• History of intolerance to subcutaneous injection;
• Participated in clinical studies of any drug or medical device within 3 months prior to drug administration or within 5 times the half-life of the investigational drug, or used the investigational drug;
• Those considered unsuitable for enrollment by the investigators.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• TQA3038 injection/placebo
TQA3038 is a Anti-Hepatitis B virus (HBV) drugs.
• Nucleotide drugs Control group
Nucleotide drugs are nucleoside reverse transcriptase inhibitors.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	Hepatobiliary Hospital of Jilin	Changchun	Jilin
China	The first hospital of Jilin University	Changchun	Jilin
China	Xiangya Third Hospital of Central of Central Suoth University	Changsha	Hunan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	The Second Affilated Hospital of Chongqing medical university	Chongqing
China	The Southwest Hospital of AMU	Chongqing
China	Mengchao Hepatobiliary Hospital of Fujian Medical University	Fuzhou	Fujian
China	The Third Affiliated Hospital of Sun Yat sen University	Guangzhou	Guangdong
China	Guizhou Provincial People's Hospital	Guiyang	Guizhou
China	The Fourth Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Shandong Public Health Clinical Center	Jinan	Shandong
China	Gansu province people hospital	Lanzhou	Gansu
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	The First Affiliated Hospital of GUANGXI Medical University	Nanning	Guangxi
China	Shanghai Tongren Hospital	Shanghai
China	Shengjing Hospital Affiliated to China Medical University	Shenyang	Liaoning
China	The sixth people's hospital at of Shenyang	Shenyang	Liaoning
China	Shiyan City Taihe Hospital	Shiyan	Hubei
China	People's Hospital of Tianjin (City)	Tianjin
China	The First Affiliated Hospital of Xinjiang Medical University	Urumqi	Xinjiang
China	Tongji Hospital of Tongji medical college of HUST	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events (AEs)	The incidence of adverse events (AEs) during treatment.	Baseline up to 16 weeks
Primary	Serious adverse events (SAEs)	The incidence of serious adverse events (SAEs) during treatment.	Baseline up to 16 weeks
Primary	Hepatitis B virus surface antigen (HbsAg)	Changes of serum HbsAg compared with baseline at the 48th week of treatment in each group.	Baseline up to 48 weeks
Secondary	Time to Reach Maximum Plasma Concentration (Tmax)	Time to reach Cmax of TQA3038 and its metabolite in plasma.	Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose
Secondary	Maximum Plasma Concentration (Cmax)	Maximum concentration of TQA3038 and its metabolite in plasma.	Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose
Secondary	Area Under the Plasma Concentration Versus Time Curve (AUC)	Area under the curve of TQA3038 and its metabolite from time 0 to last measurable time.	Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose
Secondary	Volume of distribution (Vd/F)	Volume of distribution (Vd/F) of TQA3038 in Plasma.	Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose
Secondary	Apparent Plasma Clearance (CL/F)	Apparent Plasma Clearance (CL/F) of TQA3038 in Plasma.	Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose
Secondary	Apparent Terminal Elimination Half-life (t1/2)	Apparent Elimination Half-life (T1/2) of TQA3038 in Plasma	Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose
Secondary	The incidence and titer of anti drug antibodies (ADA)	The incidence and titer of anti drug antibodies (ADA) in serum.	Day1 before administration, Week 8, Week 16, and during withdrawal
Secondary	Incidence of Neutralization antibody (Nab)	Incidence of Neutralization antibody (Nab) in serum.	Day1 before administration, Week 8, Week 16, and during withdrawal
Secondary	Hepatitis B surface antigen (HBsAg)	Changes in Hepatitis B surface antigen (HbsAg) levels from baseline during the study period.	Baseline up to 48 weeks
Secondary	Hepatitis B E antigen (HBeAg)	Changes in HbeAg levels from baseline during the study period.	Baseline up to 48 weeks