NCT05922306 Efficacy of NA Combined With PEG-IFN-α2b in the Continuous Versus Pulsed Treatment of Patients With Chronic Hepatitis B
| NCT ID | NCT05922306 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Anhui Medical University |
| Condition | Hepatitis B, Chronic |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,084 participants |
| Start Date | 2023-07 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 1,084 participants in total. It began in 2023-07 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Age 18 to 60 years, both sexes (both 18 and 60 years) 2. HBsAg positive for more than 6 months; 3. 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; 4. 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 of chronic hepatitis B. 5. negative urine or serum pregnancy test within 24 hours prior to the first dose (for women of childbearing age) Exclusion Criteria: 1. Combined active hepatitis A, C, D, E and/or HIV infection; 2. Patients who are on future and intend to continue to use tibivudine 3. 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; 4. 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 encephalopathy, history of oesophageal variceal bleeding, ascites; 5. pregnant or lactating women or patients with planned pregnancy during the study period and unwilling to use contraception 6. Neutrophil count \< 1.5 x 10\^9/L or platelet count \< 90 x 10\^9/L and creatinine \> 1.5 ULN 7. 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 psychosis; 8. history of immune-mediated disease (e.g. inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune haemolytic anaemia, scleroderma, severe psoriasis, rheumatoid arthritis) or abnormally elevated levels of autoimmune antibodies 9. Patients with severe combined diseases of the heart, lungs, kidneys, brain, blood and other vital organs, combined with other malignancies 10. 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 other evidence of retinopathy; 11. History of any organ transplantation and existing functional grafts (except corneal or hair transplants); 12. Patients who are allergic to interferon and its drug components and who, in the judgment of the investigator, are unsuitable for interferon application 13. Patients who, in the opinion of the investigator, are not suitable for participation in this study.
Contact & Investigator
Jiabing Li, MD
STUDY CHAIR
The First Affiliated Hospital of Anhui Medical University
Frequently Asked Questions
Who can join the NCT05922306 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Hepatitis B, Chronic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05922306 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05922306 currently recruiting?
Yes, NCT05922306 is actively recruiting participants. Contact the research team at aygyf@anmu.edu.cn for enrollment information.
Where is the NCT05922306 trial being conducted?
This trial is being conducted at Hefei, China.
Who is sponsoring the NCT05922306 clinical trial?
NCT05922306 is sponsored by Anhui Medical University. The principal investigator is Jiabing Li, MD at The First Affiliated Hospital of Anhui Medical University. The trial plans to enroll 1,084 participants.