drugset / Trial / NCT04168333

Safety and Efficacy of Therapeutic Hepatitis B Adenovirus Injection (T101) in Chronic Hepatitis B Patients

NCT04168333

Phase 1 Completed 36 enrolled Tasly Tianjin Biopharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Hepatitis B virus (HBV) infection is a worldwide health problem. It has been proved that the persistence of HBV is associated with the failure to stimulate an efficient HBV-specific immune response. T101, the Chinese counterpart of TG1050, is a replication-defective adenovirus serotype 5 (Ad5) expressing multiple HBV-specific antigens (core, polymerase and envelope) and is used as therapeutic vaccine for chronic hepatitis B patients. The application of T101 aims at inducing a broad HBV-specific cellular immune response and ultimately eliminating HBV infection.

Timeline

Start
2018-01-08
Primary completion
2019-10-14
Completion
2019-10-14

Drugs

EvaluationDrugModalityDoseRoute
Comparator TELIMOMAB ARITOX Vaccine 1e+09 unknown Subcutaneous
Comparator TELIMOMAB ARITOX Vaccine 1e+10 unknown Subcutaneous
Comparator TELIMOMAB ARITOX Vaccine 1e+11 unknown Subcutaneous