A Study of TQ-A3334 Combined With Entecavir in the Treatment of Chronic Hepatitis B
- Registration Number
- NCT04180150
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 12
-
- 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;
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TQ-A3334 combined with entecavir Entecavir Tablet Subjects receive TQ-A3334 (1.2 mg QW) and entecavir (0.5 mg qd) in 24 weeks Placebo combined with entecavir Placebo Subjects receive placebo (0 mg QW) and entecavir (0.5 mg qd) in 24 weeks TQ-A3334 combined with entecavir TQ-A3334 Subjects receive TQ-A3334 (1.2 mg QW) and entecavir (0.5 mg qd) in 24 weeks Placebo combined with entecavir Entecavir Tablet Subjects receive placebo (0 mg QW) and entecavir (0.5 mg qd) in 24 weeks
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (2)
The second affiliated hospital of chongqing medical university
🇨🇳Chongqing, Chongqing, China
The first hospital of Jilin University
🇨🇳Changchun, Jinlin, China