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

NCT ID: NCT04180150

Last Updated: 2019-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-18

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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TQ-A3334 combined with entecavir

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

Group Type EXPERIMENTAL

TQ-A3334

Intervention Type DRUG

TQ-A3334 is a kind of TLR7 receptor agonist.

Entecavir Tablet

Intervention Type DRUG

Entecavir (ETV) tablet is an antiviral medication used in the treatment of hepatitis B virus (HBV) infection.

Placebo combined with entecavir

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo is a treatment which is designed to have no therapeutic value.

Entecavir Tablet

Intervention Type DRUG

Entecavir (ETV) tablet is an antiviral medication used in the treatment of hepatitis B virus (HBV) infection.

Interventions

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TQ-A3334

TQ-A3334 is a kind of TLR7 receptor agonist.

Intervention Type DRUG

Placebo

Placebo is a treatment which is designed to have no therapeutic value.

Intervention Type DRUG

Entecavir Tablet

Entecavir (ETV) tablet is an antiviral medication used in the treatment of hepatitis B virus (HBV) infection.

Intervention Type DRUG

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The second affiliated hospital of chongqing medical university

Chongqing, Chongqing Municipality, China

Site Status NOT_YET_RECRUITING

The first hospital of Jilin University

Changchun, Jinlin, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Junqi Niu, M.D.

Role: CONTACT

Phone: 0431-88782168

Email: [email protected]

Hong Ren, M.D.

Role: CONTACT

Phone: 023-63693213

Email: [email protected]

Facility Contacts

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Hong Ren, M.D.

Role: primary

Junqi Niu, M.D.

Role: primary

Other Identifiers

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TQ-A3334-II-01a

Identifier Type: -

Identifier Source: org_study_id