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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04180150
Other study ID # TQ-A3334-II-01a
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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;

Study Design


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.
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