Randomized, Double-blind, Placebo-controlled Phase Ib/IIa Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets Monotherapy or in Combination With Nucleoside (Acid) Analogues in Treatment-naïve Patients and Treated Patients With Chronic Hepatitis B

NCT06150014 Phase 1/Phase 2 ACTIVE_NOT_RECRUITING

A randomized, double-blind Phase Ib/IIa multicenter trial design was used. All eligible subjects received TQA3605 tablets/placebo plus nucleoside (acid) analogues. A total of 88 subjects were required

Details

Lead sponsor	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Phase	Phase 1/Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	88
Start date	2023-12-07
Completion	2026-09

Conditions

• Chronic Hepatitis b

Interventions

• Placebo
• TQA3605 tablets
• Entecavir dispersible tablets
• Tenofovir disoproxil fumarate tablet
• Tenofovir alafenamide fumarate tablet

Primary outcomes

• The incidence of adverse events (AEs) — Up to 48 weeks
  The incidence of adverse events (AEs) during treatment
• Severity of adverse events (AEs) — Up to 48 weeks
  The severity of adverse events (AEs) during treatment
• Incidence of serious adverse events (SAEs) — Up to 48 weeks
  The incidence of serious adverse events (SAEs) during treatment
• Severity of serious adverse events (SAEs) — Up to 48 weeks
  The severity of serious adverse events (SAEs) during treatment

Countries

China