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Combination of ETV, TQ-A3334 and TQ-B2450 for CHB (Neptune Study)

NCT ID: NCT04202653

Last Updated: 2019-12-19

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-06-30

Brief Summary

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This study is a single-center, randomized, prospective, open-label Phase 2 Clinical trial to evaluate efficacy and safety of ETV and TQ-A3334 combinated with/without inhibitor of TQ-B2450 versus ETV alone in chronic hepatitis B patients. Patients were randomized to one of 3 different antiviral treatment.

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

NONE

Study Groups

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Naive:ETV

Entecavir 0.5 mg po daily for 24 weeks in naive patients

Group Type ACTIVE_COMPARATOR

ETV

Intervention Type DRUG

entecavir 0.5 mg qd

Naive:ETV+TQ-A3334

Entecavir 0.5 mg po daily plus TQ-A3334 for 24 weeks in naive patients

Group Type EXPERIMENTAL

ETV

Intervention Type DRUG

entecavir 0.5 mg qd

TQ-A3334

Intervention Type DRUG

TQ-A3334 po qw

Naive:ETV+TQ-A3334+TQ-B2450

Entecavir 0.5 mg po daily plus TQ-A3334 plus inhibitor of TQ-B2450 for 24 weeks in naive patients

Group Type EXPERIMENTAL

ETV

Intervention Type DRUG

entecavir 0.5 mg qd

TQ-A3334

Intervention Type DRUG

TQ-A3334 po qw

TQ-B2450

Intervention Type DRUG

TQ-B2450 q3w iv

Experienced:ETV

Entecavir 0.5 mg po daily for 24 weeks in treatment experienced patients

Group Type ACTIVE_COMPARATOR

ETV

Intervention Type DRUG

entecavir 0.5 mg qd

Experienced:ETV+TQ-A3334

Entecavir 0.5 mg po daily plus TQ-A3334 for 24 weeks in treatment experienced patients

Group Type EXPERIMENTAL

ETV

Intervention Type DRUG

entecavir 0.5 mg qd

TQ-A3334

Intervention Type DRUG

TQ-A3334 po qw

Experienced:ETV+TQ-A3334+TQ-B2450

Entecavir 0.5 mg po daily plus TQ-A3334 plus TQ-B2450 for 24 weeks in treatment experienced patients

Group Type EXPERIMENTAL

ETV

Intervention Type DRUG

entecavir 0.5 mg qd

TQ-A3334

Intervention Type DRUG

TQ-A3334 po qw

TQ-B2450

Intervention Type DRUG

TQ-B2450 q3w iv

Interventions

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ETV

entecavir 0.5 mg qd

Intervention Type DRUG

TQ-A3334

TQ-A3334 po qw

Intervention Type DRUG

TQ-B2450

TQ-B2450 q3w iv

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male and female patients from 18 to 65 years of age;
2. Chronic hepatitis B infection
3. Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug;
4. Agree to participate in the study and sign the patient informed consent.

Exclusion Criteria

1. Patients who had NAs resistance;
2. Other antiviral, anti-neoplastic or immunomodulatory treatment;
3. Women with ongoing pregnancy or breast-feeding;
4. Co-infection with active hepatitis A, hepatitis C, hepatitis D(Those hospitals which have the ability to do the test will do) and/or human immunodeficiency virus (HIV);
5. ALT \>10 ULN;
6. LSM \>9kPa ;
7. History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures, thalassemia);
8. Signs or symptoms of hepatocellular carcinoma;
9. Neutrophil count \< 1500 cells/mm3 or platelet count \<90,000 cells/mm3 at screening;
10. Hemoglobin \< 11.5 g/dL for females and \<12.5 g/dL for men;
11. Serum creatinine level \> 1.5 ULN in screening period.
12. Phosphorus \< 0.65 mmol/L;
13. ANA \> 1:100;
14. History of severe psychiatric disease;
15. History of a severe seizure disorder or current anticonvulsant use;
16. History of immunologically mediated disease, (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis etc.);
17. History of chronic pulmonary disease associated with functional limitation;
18. Diseases that IFN and Nucleotides or nucleosides are not suitable.
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 collaborator

Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Qin Ning

Director, Head of Department of Infectious Diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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TQ-A3334-II-02

Identifier Type: -

Identifier Source: org_study_id