Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2026-03-02 @ 4:23 PM
Study NCT ID:
NCT04168333
Status:
COMPLETED
Last Update Posted:
2019-12-04
First Post:
2019-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Therapeutic Hepatitis B Adenovirus Injection (T101) in Chronic Hepatitis B Patients
Sponsor:
Tasly Tianjin Biopharmaceutical Co., Ltd.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
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).
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: