Chronic Hepatitis B
Conditions
Brief summary
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.
Interventions
DRUGTQ-A3334
TQ-A3334 is a kind of TLR7 receptor agonist.
DRUGPlacebo
Placebo is a treatment which is designed to have no therapeutic value.
DRUGEntecavir Tablet
Entecavir (ETV) tablet is an antiviral medication used in the treatment of hepatitis B virus (HBV) infection.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 1\. 18 and 65 years old ; 2. HBsAg positive at least for 6 months ; 3. HBeAg positive chronic hepatitis B, HBV DNA \> 10\^5 copies/ml; 4. Fibroscan ≤ 12.4 Kpa，2×ULN ≤ ALT ≤ ULN; 5. New diagnosed chronic hepatitis B subjects;
Exclusion criteria
* 1.Combined with other virus infection ; 2.Has cirrhosis or hepatocellular carcinoma; 3.Has autoimmune diseases; 4.Has thyroid disease; 5.Has eye diseases; 6.Has clinically significant abnormalities/diseases ≥ grade 2; 7.Has history of chronic kidney disease, renal insufficiency, renal anemia; 8.Peripheral blood index is low; 9.Has a history of allergy to experimental drugs or their excipients; 10.Has participated in other clinical trials within 3 months; 11.Breastfeeding or pregnant women.; Men unwilling to use adequate contraceptive measures during the study; 12.According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.; 13.Has history of drug abuse in the past five years;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 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. | Cmax is the maximum plasma concentration of TQ-A3334 or metabolite(s). |
| Tmax | 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. | To characterize the pharmacokinetics of TQ-A3334 by assessment of time to reach maximum plasma concentration. |
| AUC0-t | 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. | To characterize the pharmacokinetics of TQB3804 by assessment of area under the plasma concentration time curve from zero to infinity. |
| Cytokine | Hour 0, 1.5 , 12 , 24 , 72 hours post-dose at week 1 and week 12; Hour 0 at week 7. | Including IFN-α, IFN-γ, TNF-α, IL-6, IL-2, MCP-1 and so on. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HBV biomarker | Day 1 pre-dose, day 84, day 168, day 336 post-dose. | Including HBsAg, HBsAb, HBeAb, anti-HBc, HBV-DNA, HBV RNA and HBcrAg. |
| Lymphocyte function | Hour 0 pre-dose, day 56, day 84, day 168 at post-dose. | Analysis of immune cell response to hepatitis B antigen after treatment. |
Countries
China
Contacts
Primary ContactJunqi Niu, M.D.
Backup ContactHong Ren, M.D.
Outcome results
None listed