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UNKNOWNPHASE2

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

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

NCT04180150•Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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;

Locations (2)

The second affiliated hospital of chongqing medical university

Chongqing, Chongqing Municipality, China

The first hospital of Jilin University

Changchun, Jinlin, China

Key Dates

Start Date

November 18, 2019

Primary Completion Date

September 30, 2020

Completion Date

December 31, 2021

Last Updated

December 16, 2019

Enrollment

ESTIMATED participants

Conditions

Chronic Hepatitis B

Interventions

TQ-A3334

DRUG

Placebo

DRUG

Entecavir Tablet

DRUG

Contacts

Junqi Niu, M.D.

CONTACT

0431-88782168 junqiniu@aliyun.com

Hong Ren, M.D.

CONTACT

023-63693213 renhong0531@vip.sina.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 16, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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