A Phase II Clinical Trial to Evaluate the Safety and Efficacy of Therapeutic Hepatitis B Adenovirus Injection (T101) Combined With Nucleoside (Acid) Analogues in Chronic Hepatitis B Patients

Tasly Tianjin Biopharmaceutical Co., Ltd.3 sites in 1 country100 target enrollmentDecember 10, 2019

ConditionsHepatitis B Virus (HBV)

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Hepatitis B Virus (HBV)
Sponsor: Tasly Tianjin Biopharmaceutical Co., Ltd.
Enrollment: 100
Locations: 3
Primary Endpoint: All the observed or reported AEs (adverse events)
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A multi-center, randomized, open-label, group controlled study to evaluate the safety and efficacy of T101 combined with nucleoside (acid) analogues in chronic hepatitis B patients.

Registry

clinicaltrials.gov

Start Date

December 10, 2019

End Date

December 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Tasly Tianjin Biopharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients must meet all the following inclusion criteria to be enrolled in this study:
•Patients between the ages of 18 and 60 years, male or female;
•Body weight is no less than 45kg for female and no less than 50kg for male;
•Meets the diagnosis and treatment standards of chronic hepatitis B in China's 2015 Guidelines for the Prevention and Treatment of Chronic Hepatitis B;
•Currently, should have taken nucleoside (acid) analogues for 1 year or more;
•HBV DNA\<100 IU/ml; HBsAg is positive and no more than 3000 IU/ml；HBeAg is negative；
•Be able to understand and sign informed consent.

Exclusion Criteria

•Patients with any of the following items will not be enrolled in this study:
•Pregnant or lactating women; male or female who have planned to have children from the start of the study to sixth month after the end of the study.
•Have received interferon treatment within 6 months prior to the screening;
•Have taken strong immunomodulators (such as adrenocortical hormone, thymosin alpha 1, thymosin 5, etc.) within 6 months before the screening, and the course of treatment was more than 2 weeks;
•Have taken hepatotoxic drugs (such as dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) within 6 months before screening, and the course of treatment was more than 2 weeks;
•Currently or previously diagnosed or suspected with cirrhosis or liver cancer; or AFP \> 50ng/ml;
•Liver diseases caused by other causes: including alcoholic hepatitis, drug hepatitis, autoimmune liver disease;
•Currently be infected of HAV, HCV, HDV, HEV, HIV and syphilis;
•Have mental diseases, including but not limited to depression, anxiety, mania, schizophrenia;
•Uncontrolled epilepsy;

Outcomes

Primary Outcomes

All the observed or reported AEs (adverse events)

Time Frame: through study completion, an average of 60 weeks

observe and record all the AEs of patients during the clinical trial and determine their correlation with the investigational medical product

HBsAg change

Time Frame: Day106 (Week15), Day211 (Week30), Day316 (Week45), Day337 (Week48), Day421 (Week60) after administration

evaluate the HBsAg change from the baseline to evaluate the efficacy of T101

Secondary Outcomes

Negative convention rate of HBsAg(Day316 (Week45), Day337 (Week48), Day421 (Week60) after administration)
Positive convention rate of HBsAb(Day316 (Week45), Day337 (Week48), Day421 (Week60) after administration)
The percentage of Subjects' HBsAg decrease ≥ 1 log(Day106 (Week15), Day211 (Week30), Day316 (Week45), Day337 (Week48), Day421 (Week60) after administration)
The percentage of Subjects' HBsAg decrease ≥ 0.5 log(Day106 (Week15), Day211 (Week30), Day316 (Week45), Day337 (Week48), Day421 (Week60) after administration)