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Compares treatment options for Hepatitis B, Chronic
Official title Efficacy of NA Combined With PEG-IFN-α2b in the Continuous Versus Pulsed Treatment of Patients With Chronic Hepatitis B
ClinicalTrials.gov ID: NCT05922306
What this study is testing
What is PEGylated recombinant human interferon alpha-2b injection?
PEGylated recombinant human interferon alpha-2b injection is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for hepatitis b, chronic.
Also referred to as Nucleotide analogues.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Previous studies have shown that there are alterations in the number and affinity of interferon receptors during interferon therapy and that such alterations recover to varying degrees some time after the end of treatment. It can be conjectured that the rest period of pulsed therapy facilitates the recovery of type I interferon receptors and thus the next round of IFN therapy compared to a continuous regimen of interferon.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Age 18 to 60 years, both sexes (both 18 and 60 years)
- HBsAg positive for more than 6 months;
- NAs treated patients on continuous NA therapy for more than 6 months with HBsAg ≥ 1500 IU/ml and HBV-DNA \< 500 IU/ml at enrolment;
- Primary treated patients with surface antigen \>1500 IU, unlimited E antigen and unlimited HBV DNA at enrolment, meeting the treatment indications of...
- negative urine or serum pregnancy test within 24 hours prior to the first dose (for women of childbearing age)
You likely can't join if
- Combined active hepatitis A, C, D, E and/or HIV infection;
- Patients who are on future and intend to continue to use tibivudine
- methaemoglobin greater than 100ng/ml at screening; or methaemoglobin that has not remained stable for 3 months prior to the trial and/or liver...
- decompensated liver disease (Child-Pugh score ≥ 7), meaning that patients will be excluded if one of the following is met: prolonged prothrombin time...
- pregnant or lactating women or patients with planned pregnancy during the study period and unwilling to use contraception
- Neutrophil count \ 1.5 ULN
See the full eligibility criteria
- Age 18 to 60 years, both sexes (both 18 and 60 years)
- HBsAg positive for more than 6 months;
- NAs treated patients on continuous NA therapy for more than 6 months with HBsAg ≥ 1500 IU/ml and HBV-DNA \< 500 IU/ml at enrolment;
- Primary treated patients with surface antigen \>1500 IU, unlimited E antigen and unlimited HBV DNA at enrolment, meeting the treatment indications of the 2019 edition of the guidelines for the prevention and treatment...
- negative urine or serum pregnancy test within 24 hours prior to the first dose (for women of childbearing age)
- Combined active hepatitis A, C, D, E and/or HIV infection;
- Patients who are on future and intend to continue to use tibivudine
- methaemoglobin greater than 100ng/ml at screening; or methaemoglobin that has not remained stable for 3 months prior to the trial and/or liver imaging suggestive of liver tumours;
- decompensated liver disease (Child-Pugh score ≥ 7), meaning that patients will be excluded if one of the following is met: prolonged prothrombin time ≥ 3 seconds, serum bilirubin \> 34umol/L, history of hepatic...
- pregnant or lactating women or patients with planned pregnancy during the study period and unwilling to use contraception
- Neutrophil count \ 1.5 ULN
- History of severe psychiatric illness, especially depression. Major psychosis defined as major depressive disorder or psychosis, suicide attempts, hospitalisation for psychosis or incapacity for a period of time due to...
- history of immune-mediated disease (e.g. inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune haemolytic anaemia, scleroderma, severe psoriasis, rheumatoid arthritis) or...
- Patients with severe combined diseases of the heart, lungs, kidneys, brain, blood and other vital organs, combined with other malignancies
- History of severe epilepsy or current treatment with anti-epileptic drugs. Unstable control of diabetes mellitus, hypertension, thyroid disease, etc. Patients with a history of severe retinopathy or as indicated by...
- History of any organ transplantation and existing functional grafts (except corneal or hair transplants);
- Patients who are allergic to interferon and its drug components and who, in the judgment of the investigator, are unsuitable for interferon application
- Patients who, in the opinion of the investigator, are not suitable for participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.