Hepatitis B Virus (HBV) Clinical Trial
Official title:
A Phase I, Single Center, Randomized, Double-blind, Placebo Controlled, Single Dose (SD) and Multiple Dose (MD), Dose-escalation Clinical Trial to Evaluate the Tolerability and Preliminary Antiviral Activity of Therapeutic Hepatitis B Adenovirus Injection (T101) in Chronic Hepatitis B Patients
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.
This study is a randomized, double-blind, placebo-controlled, single dose (SD) and multiple
dose (MD) administration study.
Primary Objective: Safety and tolerability;
Secondary Objective:
1. Antiviral activity of T101 (HBsAg levels).
2. Cellular (HBV-specific) and humoral (AD5 neutralizing antibodies, NAd5) immune responses
to T101.
Key Inclusion Criteria:
1. Chronic hepatitis B patients with positive HBsAg.
2. Patients must be receiving antiviral treatment with nucleoside analogs and have negative
HBV DNA (defined as HBV DNA <20 IU/mL).
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00734162 -
Evaluation of Tenofovir Disoproxil Fumarate in Adolescents With Chronic Hepatitis B Infection
|
Phase 3 | |
| Active, not recruiting |
NCT04189276 -
Safety and Efficacy of Therapeutic Hepatitis B Adenovirus Injection (T101) Combined With Nucleoside (Acid) Analogues in Chronic Hepatitis B Patients
|
Phase 2 |