A Study of TQ-A3334 Combined With Entecavir in the Treatment of Chronic Hepatitis B

Chronic Hepatitis B Clinical Trial

Official title:

A Randomized, Double-blinded, Placebo-controlled, Phase IIa Study of TQ-A3334 Combined With Entecavir in the Treatment of Untreated or HBV DNA Negative Subjects With Chronic Hepatitis B

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04180150
• Other study ID #: TQ-A3334-II-01a
• Status: Recruiting
• Phase: Phase 2
• Start date: November 18, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2019
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Junqi Niu, M.D.
• Phone: 0431-88782168
• Email: junqiniu[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 31, 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• TQ-A3334
TQ-A3334 is a kind of TLR7 receptor agonist.
• Placebo
Placebo is a treatment which is designed to have no therapeutic value.
• Entecavir Tablet
Entecavir (ETV) tablet is an antiviral medication used in the treatment of hepatitis B virus (HBV) infection.

Locations

Country	Name	City	State
China	The first hospital of Jilin University	Changchun	Jinlin
China	The second affiliated hospital of chongqing medical university	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	Cytokine	Including IFN-a, IFN-?, TNF-a, 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.
Secondary	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.
Secondary	Lymphocyte function	Analysis of immune cell response to hepatitis B antigen after treatment.	Hour 0 pre-dose, day 56, day 84, day 168 at post-dose.