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

CTTQ

Status and phase: Unknown; Phase 2

Conditions: Chronic Hepatitis B

Treatments: Drug: TQ-A3334; Drug: Placebo; Drug: Entecavir Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT04180150

TQ-A3334-II-01a

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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12 participants in 2 patient groups, including a placebo group

TQ-A3334 combined with entecavir

Experimental group

Description:

Subjects receive TQ-A3334 (1.2 mg QW) and entecavir (0.5 mg qd) in 24 weeks

Treatment:

Drug: Entecavir Tablet

Drug: TQ-A3334

Placebo combined with entecavir

Placebo Comparator group

Description:

Subjects receive placebo (0 mg QW) and entecavir (0.5 mg qd) in 24 weeks

Treatment:

Drug: Placebo

Drug: Entecavir Tablet