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

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Treatments: Entecavir

Criteria

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;