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

June 6, 2024 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

162

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Chongqing, China, 400038
        • The Southwest Hospital of Amu
        • Contact:
        • Contact:
          • YongChuan Chen, Master
          • Phone Number: 17749922271
          • Email: zwmcyc@163.com
      • Chongqing, China, 400080
        • The Second Affilated Hospital of Chongqing Medical University
        • Contact:
      • Shanghai, China, 200000
        • Shanghai Tongren Hospital
        • Contact:
      • Tianjin, China, 300000
        • People's Hospital of Tianjin (City)
        • Contact:
    • Anhui
      • Bengbu, Anhui, China, 233000
        • The First Affiliated Hospital of Bengbu Medical College
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350025
        • Mengchao Hepatobiliary Hospital of Fujian Medical University
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730030
        • Gansu Province People Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • The third affiliated hospital of Sun Yat sen University
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
    • Guizhou
      • Guiyang, Guizhou, China, 550002
        • Guizhou Provincial People's Hospital
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • The Fourth Affiliated Hospital of Harbin Medical University
        • Contact:
    • Hubei
      • Shiyan, Hubei, China, 442000
        • Shiyan City Taihe Hospital
        • Contact:
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital of Tongji Medical College of HUST
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410000
        • Xiangya Third Hospital of Central of Central Suoth University
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330000
        • The First Affiliated Hospital of Nanchang University
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130061
        • The First Hospital of Jilin University
        • Contact:
        • Contact:
      • Changchun, Jilin, China, 130062
        • Hepatobiliary Hospital Of Jilin
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110136
        • Shengjing Hospital affiliated to China Medical University
        • Contact:
      • Shenyang, Liaoning, China, 110006
        • The sixth people's hospital at of Shenyang
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250102
        • Shandong Public Health Clinical Center
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital of Sichuan University
        • Contact:
    • Xinjiang
      • Urumqi, Xinjiang, China, 830054
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TQA3038 injection/placebo

100/0mg~400/0mg, subcutaneous injection, 2 weeks~8 weeks as a cycle, a total of 2 doses.

Nucleotide drugs: Oral, once a day, orally administered with food, for 16 weeks.
Drug: TQA3038 injection/placebo
TQA3038 is a Anti-Hepatitis B virus (HBV) drugs.
Active Comparator: Nucleotide drugs Control group
Nucleotide drugs: Oral, once a day, orally administered with food, for 48weeks.
Drug: Nucleotide drugs Control group
Nucleotide drugs are nucleoside reverse transcriptase inhibitors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events (AEs)
Time Frame: Baseline up to 16 weeks
The incidence of adverse events (AEs) during treatment.
Baseline up to 16 weeks
Serious adverse events (SAEs)
Time Frame: Baseline up to 16 weeks
The incidence of serious adverse events (SAEs) during treatment.
Baseline up to 16 weeks
Hepatitis B virus surface antigen (HbsAg)
Time Frame: Baseline up to 48 weeks
Changes of serum HbsAg compared with baseline at the 48th week of treatment in each group.
Baseline up to 48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Reach Maximum Plasma Concentration (Tmax)
Time Frame: 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
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
Maximum Plasma Concentration (Cmax)
Time Frame: 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
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
Area Under the Plasma Concentration Versus Time Curve (AUC)
Time Frame: 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
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
Volume of distribution (Vd/F)
Time Frame: 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
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
Apparent Plasma Clearance (CL/F)
Time Frame: 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
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
Apparent Terminal Elimination Half-life (t1/2)
Time Frame: 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
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
The incidence and titer of anti drug antibodies (ADA)
Time Frame: Day1 before administration, Week 8, Week 16, and during withdrawal
The incidence and titer of anti drug antibodies (ADA) in serum.
Day1 before administration, Week 8, Week 16, and during withdrawal
Incidence of Neutralization antibody (Nab)
Time Frame: Day1 before administration, Week 8, Week 16, and during withdrawal
Incidence of Neutralization antibody (Nab) in serum.
Day1 before administration, Week 8, Week 16, and during withdrawal
Hepatitis B surface antigen (HBsAg)
Time Frame: Baseline up to 48 weeks
Changes in Hepatitis B surface antigen (HbsAg) levels from baseline during the study period.
Baseline up to 48 weeks
Hepatitis B E antigen (HBeAg)
Time Frame: Baseline up to 48 weeks
Changes in HbeAg levels from baseline during the study period.
Baseline up to 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

June 6, 2024

First Submitted That Met QC Criteria

June 6, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Actual)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQA3038-Ib/IIa-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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