Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | TQA3605 placebo tablets were orally administered on an empty stomach (at least 2 hours before or after meals) with warm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse events (AEs) | The incidence of adverse events (AEs) during treatment | Up to 48 weeks |
| Severity of adverse events (AEs) | The severity of adverse events (AEs) during treatment | Up to 48 weeks |
| Incidence of serious adverse events (SAEs) | The incidence of serious adverse events (SAEs) during treatment | Up to 48 weeks |
| Severity of serious adverse events (SAEs) | The severity of serious adverse events (SAEs) during treatment | Up to 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of abnormal laboratory test values | The incidence of abnormal laboratory values during treatment, e.g. triglycerides. | Up to 48 weeks |
| Severity of abnormal laboratory test values | The severity of abnormal laboratory values during treatment, e.g. triglycerides. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400010 | China | ||
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| 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. |
|
| Up to 48 weeks |
| Deoxyribonucleic acid level of hepatitis B virus | Changes in hepatitis B virus deoxyribonucleic acid (HBV DNA) levels from baseline | At week 12, week 24, week 36 and week 48 or when subjects withdrawal from the study |
| Hepatitis B surface antigen | Changes in serum hepatitis B surface antigen (HBsAg) from baseline | At week 12, week 24, week 36 and week 48 or when subjects withdrawal from the study |
| Hepatitis B e antigen | Changes in serum hepatitis B e antigen (HBeAg) from baseline | At week 12, week 24, week 36 and week 48 or when subjects withdrawal from the study |
| Serologic clearance and/or serologic conversion of HBsAg | Proportion of subjects with HBsAg serologic clearance and/or serologic conversion | At week 12, week 24, week 36 and week 48 or when subjects withdrawal from the study |
| Serologic clearance and/or serologic conversion of HBeAg | Proportion of subjects with HBeAg serologic clearance and/or serologic conversion | At week 12, week 24, week 36 and week 48 or when subjects withdrawal from the study |
| Virological breakthrough rate | The proportion of subjects who achieved a virological breakthrough (defined as a confirmed increase of HBV DNA levels >1.0 log10 IU/ml from the minimum during treatment). | At week 12, week 24, week 36 and week 48 or when subjects withdrawal from the study |
| Peak time (Tmax) | Time to reach peak blood concentration after a single dose | pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10. |
| Peak concentration | The highest plasma drug concentration that can be achieved after medication | pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10. |
| Area under blood concentration-time curve (AUC) | The amount of drug absorbed into the human circulation after a single dose can be estimated using the area under the blood concentration-time curve | pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10. |
| Apparent volume of distribution (Vd/F) | When a drug reaches homeostasis in the body, the ratio of the amount of drug in the body to the blood concentration is called the apparent volume of distribution. | pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10. |
| Plasma clearance | The amount of plasma that the kidneys completely clear in unit time (per minute). | pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10. |
| Elimination half-life | The time it takes for the plasma concentration to drop by half. | pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10. |
| Steady state peak time | The time required to reach peak steady-state concentration after administration | pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10. |
| Steady state maximum concentration | The highest blood concentration that occurs after stabilization | pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10. |
| Steady state minimal concentration | The lowest blood concentration that occurs after stabilization | pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10. |
| The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University |
| Chongqing |
| Chongqing Municipality |
| 400038 |
| China |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shannxi | 710061 | China |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C413685 | entecavir |
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided