NCT04168333

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Tasly Tianjin Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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).

Conditions

• Hepatitis B Virus (HBV)

Interventions

Type	Name	Description
BIOLOGICAL	T101 Group	Single Dose (SD) Cohort: In each group, 3 of chronic hepatitis B patients will be subcutaneously injected with different dose level of T101 at 1.0E+9VP (Group1)/1.0E+10VP (Group2)/1.0E+11VP (Group 3) on D1. Multiple Dose (MD) Cohort: In each group, 9 of chronic hepatitis B patients will be subcutaneously injected with different dose level of T101 at 1.0E+10VP (Group1)/1.0E+11VP (Group2) on D1, D8, D15.
BIOLOGICAL	Placebo Group	Single Dose (SD) Cohort: 3 of chronic hepatitis B patients will be subcutaneously injected with placebo on D1. Multiple Dose (MD) Cohort: 6 of chronic hepatitis B patients will be subcutaneously injected with placebo on D1, D8, D15.

Timeline

• Start date: 2018-01-08
• Primary completion: 2019-10-14
• Completion: 2019-10-14
• First posted: 2019-11-19
• Last updated: 2019-12-04

Locations

1 site across 1 country: China