Chronic Hepatitis bPhase 2NeptuneNCT04202653

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

A Phase 2 study testing ETV, TQ-A3334 and TQ-B2450 in people with Chronic Hepatitis b, run by Tongji Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Chronic Hepatitis b
What is being tested?: ETV, TQ-A3334 and TQ-B2450
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteChina
Study dates: 1 Jan 2020to 31 Dec 2023
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

Patients who had NAs resistance;
Other antiviral, anti-neoplastic or immunomodulatory treatment;
Women with ongoing pregnancy or breast-feeding;
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);
ALT >10 ULN;
LSM >9kPa ;

Show all 18Show fewer

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);
Signs or symptoms of hepatocellular carcinoma;
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;
ANA > 1:100;
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.

Trial locations and contacts

1 site in 1 country.

China1 site

Tongji Hospital
Wuhan, Hubei, 430030

Other trials in China

About this study

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

Conditions: Chronic Hepatitis b
Being tested: ETV, TQ-A3334, TQ-B2450
Medical subject headings: Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ETVDrug
entecavir 0.5 mg qd
TQ-A3334Drug
TQ-A3334 po qw
TQ-B2450Drug
TQ-B2450 q3w iv

Study groups in NCT04202653
Study group	Role	What they receive
Naive:ETV	Active comparator	Entecavir 0.5 mg po daily for 24 weeks in naive patients Receives: Drug: ETV
Naive:ETV+TQ-A3334	Experimental	Entecavir 0.5 mg po daily plus TQ-A3334 for 24 weeks in naive patients Receives: Drug: ETV; Drug: TQ-A3334
Naive:ETV+TQ-A3334+TQ-B2450	Experimental	Entecavir 0.5 mg po daily plus TQ-A3334 plus inhibitor of TQ-B2450 for 24 weeks in naive patients Receives: Drug: ETV; Drug: TQ-A3334; Drug: TQ-B2450
Experienced:ETV	Active comparator	Entecavir 0.5 mg po daily for 24 weeks in treatment experienced patients Receives: Drug: ETV
Experienced:ETV+TQ-A3334	Experimental	Entecavir 0.5 mg po daily plus TQ-A3334 for 24 weeks in treatment experienced patients Receives: Drug: ETV; Drug: TQ-A3334
Experienced:ETV+TQ-A3334+TQ-B2450	Experimental	Entecavir 0.5 mg po daily plus TQ-A3334 plus TQ-B2450 for 24 weeks in treatment experienced patients Receives: Drug: ETV; Drug: TQ-A3334; Drug: TQ-B2450

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in HBsAg quantification at week 24
HBsAg quantification are measured
Measured: week 24

Secondary outcomes (5)

HBsAg loss rates at week 24
HBsAg loss rates are measured
Measured: week 24
HBsAg seroconversion rates at week 24
HBsAg seroconversion rates are measured
Measured: week 24
HBeAg loss rates at week 24
HBeAg loss rates are measured
Measured: week 24
HBeAg seroconversion rates at week 24
HBeAg seroconversion rates are measured
Measured: week 24
HBV DNA<20IU/mL rates at week 24
HBV DNA<20IU/mL rates are measured
Measured: week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202031 Dec 2023

First posted17 Dec 2019
Study start1 Jan 2020
Primary completion30 Jun 2023
Study completion31 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Hepatitis bStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04202653
Sponsor's protocol ID: TQ-A3334-II-02
Acronym: Neptune
Status last verified: Dec 2019
First submitted: 15 Dec 2019
Last updated: 6 Oct 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of Combination Therapy of BRII-179, BRII-835 and PEG-IFNα in Participants With Chronic Hepatitis B Virus (HBV) Infection (ENHANCE)
Chronic Hepatitis B Virus (HBV) Infection
Not yet recruitingPhase 1
A Clinical Study of AHB-121 in Healthy Participants and Chronic Hepatitis B (CHB) Participants
Chronic Hepatitis B Virus
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection

All Chronic Hepatitis b trials