NCT04189276

Safety and Efficacy of Therapeutic Hepatitis B Adenovirus Injection (T101) Combined With Nucleoside (Acid) Analogues in Chronic Hepatitis B Patients

A Phase II Clinical Trial to Evaluate the Safety and Efficacy of Therapeutic Hepatitis B Adenovirus Injection (T101) Combined With Nucleoside (Acid) Analogues in Chronic Hepatitis B Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Tasly Tianjin Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

A multi-center, randomized, open-label, group controlled study to evaluate the safety and efficacy of T101 combined with nucleoside (acid) analogues in chronic hepatitis B patients.

Conditions

• Hepatitis B Virus (HBV)

Interventions

Type	Name	Description
BIOLOGICAL	ETV/TDF+T101 No.1	Patients will be injected with T101 once on Day1 (Week0), Day8 (Week1), Day15 (Week2), Day106 (Week15), Day113 (Week16), Day120 (Week17), Day211 (Week30), Day218 (Week31), Day225 (Week32), Day316 (Week45), Day323 (Week46), Day330 (Week47); ETV or TDF will be administrated once each day successively until Day420.
BIOLOGICAL	ETV/TDF+T101 No.2	Patients will be injected with T101 once on Day1 (Week0), Day106 (Week15), Day211 (Week30), Day316 (Week45); ETV or TDF will be administrated once each day successively until Day420.
BIOLOGICAL	ETV or TDF	Patients will be administrated ETV or TDF once each day successively until Day420.
BIOLOGICAL	ETV/TDF+Peg-IFNα-2b	Patients will be administrated Peg-IFNα-2b successively once a week until Day330 (Week47); ETV or TDF will be administrated once each day successively until Day420.

Timeline

• Start date: 2019-12-10
• Primary completion: 2021-06-30
• Completion: 2021-12-01
• First posted: 2019-12-06
• Last updated: 2021-02-08

Locations

3 sites across 1 country: China