Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06150014 | A Clinical Study of TQA3605 Tablets Monotherapy or in Combination With Nucleoside (Acid) Analogues in Treatment Naive and Treated Patients With Chronic Hepatitis B | PHASE1 | ACTIVE NOT_RECRUITING | 88 | — | — | Dec 7, 2023 | Sep 1, 2026 | Nov 14, 2024 | 3 | China |
The incidence of adverse events (AEs) during treatment
The severity of adverse events (AEs) during treatment
The incidence of serious adverse events (SAEs) during treatment
The severity of serious adverse events (SAEs) during treatment
| Arm | Type | Description |
|---|---|---|
| Placebo +Nucleoside (acid) analogs (NAs) combination therapy 24 weeks | PLACEBO_COMPARATOR | Placebo and Nucleoside (acid) analogues, taken orally once daily, continue for 24 weeks. |
| 50 mg of TQA3605 tablets +NAs combination therapy 24 weeks | ACTIVE_COMPARATOR | 50 mg of TQA3605 tablets and Nucleoside (acid) analogues, taken orally once daily, continue for 24 weeks. |
| 100 mg of TQA3605 tablets +NAs combination therapy 48 weeks | ACTIVE_COMPARATOR | TQA3605 is taken orally 100mg once daily; Nucleoside (acid) analogues were used once daily for 48 weeks. |
| 200 mg of TQA3605 tablets +NAs combination therapy 48 weeks | ACTIVE_COMPARATOR | TQA3605 is taken orally 200mg once daily; Nucleoside (acid) analogues were used once daily for 48 weeks. |
| Placebo +Nucleoside (acid) analogs (NAs) combination therapy | PLACEBO_COMPARATOR | Placebo taken orally once daily, continue for 12 weeks. Placebo was then combined with nucleoside (acid) analogues (once daily) for 36 weeks |
| 100 mg of TQA3605 tablets +NAs combination therapy | ACTIVE_COMPARATOR | TQA3605 was taken orally 100mg once a day for 12 weeks. It was then combined with nucleoside (acid) analogues (once daily) for 36 weeks. |
| 200 mg of TQA3605 tablets +NAs combination therapy | ACTIVE_COMPARATOR | TQA3605 was taken orally 200mg once a day for 12 weeks. It was then combined with nucleoside (acid) analogues (once daily) for 36 weeks. |
| 300 mg of TQA3605 tablets+NAs combination therapy | ACTIVE_COMPARATOR | TQA3605 was taken orally 300mg once a day for 12 weeks. It was then combined with nucleoside (acid) analogues (once daily) for 36 weeks. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | TQA3605 placebo tablets were orally administered on an empty stomach (at least 2 hours before or after meals) with warm. |
| TQA3605 tablets | DRUG | TQA3605 inhibits viral replication. |
| Entecavir dispersible tablets | DRUG | Entecavir inhibits viral replication and indicated for chronic hepatitis B treatment. |
| Tenofovir disoproxil fumarate tablet | DRUG | Tenofovir disoproxil fumarate is a Nucleotide reverse transcriptase inhibitor. |
| Tenofovir alafenamide fumarate tablet | DRUG | Tenofovir alafenamide fumarate inhibits hepatitis B virus replication. |
Inclusion Criteria: * Subjects voluntarily participate in this study and sign informed consent; * Male and female, ≥18 years old and ≤70 years old (subject to the date of signing the informed consent); * Patients diagnosed with chronic hepatitis B (CHB) who have been serum HBsAg positive for more t...