drugset / Trial / NCT04168333
Safety and Efficacy of Therapeutic Hepatitis B Adenovirus Injection (T101) in Chronic Hepatitis B Patients
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | TELIMOMAB ARITOX | Vaccine | 1e+09 unknown | Subcutaneous |
| Comparator | TELIMOMAB ARITOX | Vaccine | 1e+10 unknown | Subcutaneous |
| Comparator | TELIMOMAB ARITOX | Vaccine | 1e+11 unknown | Subcutaneous |