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
This is a randomized, double-blinded, placebo-controlled, phase IIa study to evaluate safety and efficacy of TQ-A3334 combined with entecavir in the untreated or HBV DNA negative subjects with Chronic Hepatitis B.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQ-A3334 combined with entecavir | Experimental | Subjects receive TQ-A3334 (1.2 mg QW) and entecavir (0.5 mg qd) in 24 weeks |
|
| Placebo combined with entecavir | Placebo Comparator | Subjects receive placebo (0 mg QW) and entecavir (0.5 mg qd) in 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQ-A3334 | Drug | TQ-A3334 is a kind of TLR7 receptor agonist. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Cmax is the maximum plasma concentration of TQ-A3334 or metabolite(s). | Hour 0, 5, 10, 20, 30 minutes, 1, 2 , 3 , 6 , 12, 24, 72 , 168 hours post-dose at week 1 and week 12; Hour 0 of week 4, week 7, week 9, week 11. |
| Tmax | To characterize the pharmacokinetics of TQ-A3334 by assessment of time to reach maximum plasma concentration. | Hour 0, 5, 10, 20, 30 minutes, 1, 2 , 3 , 6 , 12, 24, 72 , 168 hours post-dose at week 1 and week 12; Hour 0 of week 4, week 7, week 9, week 11. |
| AUC0-t | To characterize the pharmacokinetics of TQB3804 by assessment of area under the plasma concentration time curve from zero to infinity. | Hour 0, 5, 10, 20, 30 minutes, 1, 2 , 3 , 6 , 12, 24, 72 , 168 hours post-dose at week 1 and week 12; Hour 0 of week 4, week 7, week 9, week 11. |
| Cytokine | Including IFN-α, IFN-γ, TNF-α, IL-6, IL-2, MCP-1 and so on. | Hour 0, 1.5 , 12 , 24 , 72 hours post-dose at week 1 and week 12; Hour 0 at week 7. |
| Measure | Description | Time Frame |
|---|---|---|
| HBV biomarker | Including HBsAg, HBsAb, HBeAb, anti-HBc, HBV-DNA, HBV RNA and HBcrAg. | Day 1 pre-dose, day 84, day 168, day 336 post-dose. |
| Lymphocyte function | Analysis of immune cell response to hepatitis B antigen after treatment. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junqi Niu, M.D. | Contact | 0431-88782168 | junqiniu@aliyun.com | |
| Hong Ren, M.D. | Contact | 023-63693213 | renhong0531@vip.sina.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The second affiliated hospital of chongqing medical university | Not yet recruiting | Chongqing | Chongqing Municipality | China |
Not provided
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C413685 | entecavir |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Placebo is a treatment which is designed to have no therapeutic value. |
|
| Entecavir Tablet | Drug | Entecavir (ETV) tablet is an antiviral medication used in the treatment of hepatitis B virus (HBV) infection. |
|
| Hour 0 pre-dose, day 56, day 84, day 168 at post-dose. |
| The first hospital of Jilin University | Recruiting | Changchun | Jinlin | China |
|
| 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 |