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NCT04202653CompletedPhase 2

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

New Combination of ETV, TQ-A3334 and TQ-B2450 for the Treatment of Chronic Hepatitis B Virus Infection

Source: ClinicalTrials.gov · Last updated 6 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
24 (actual)
First submitted
15 Dec 2019
Start date
1 Jan 2020
Primary completion date
30 Jun 2023
Lead sponsor
Tongji Hospital
Diseases
Hepatitis B
NCT number
NCT04202653

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 24
  • From 1 Jan 2020 to the primary completion date, 30 Jun 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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);
  • 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);
  • History of severe psychiatric disease;
  • History of a severe seizure disorder or current anticonvulsant use;
  • History of immunologically mediated disease, (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis etc.);
  • History of chronic pulmonary disease associated with functional limitation;
  • Diseases that IFN and Nucleotides or nucleosides are not suitable.

Lab values

  • ALT \>10 ULN;
  • Neutrophil count \< 1500 cells/mm3 or platelet count \<90,000 cells/mm3 at screening;
  • Hemoglobin \< 11.5 g/dL for females and \<12.5 g/dL for men;
  • Serum creatinine level \> 1.5 ULN in screening period.
  • Phosphorus \< 0.65 mmol/L;

Other

  • Patients who had NAs resistance;
  • Other antiviral, anti-neoplastic or immunomodulatory treatment;
  • Women with ongoing pregnancy or breast-feeding;
  • LSM \>9kPa ;
  • Signs or symptoms of hepatocellular carcinoma;
  • ANA \> 1:100;

Who the study is looking for

  • Male and female patients from 18 to 65 years of age;
  • Chronic hepatitis B infection
  • 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;
  • Agree to participate in the study and sign the patient informed consent.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Tongji Hospital
Coordinator of this site? Confirm its status
WuhanChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.