Comparing continuous and pulsed treatment for chronic hepatitis B
A Multicenter, Prospective Cohort Study: Efficacy of NA Combined With PEG-IFN-α2b Continuous Versus Pulsed Therapy for 96 Weeks in Patients With Chronic Hepatitis B.
This study is testing whether a continuous or pulsed treatment using a combination of medications can help people with chronic hepatitis B get better results.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 1084 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Anhui Medical University Academic / other |
| Locations | 1 site (Hefei, Anhui) |
| Trial ID | NCT05922306 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy of nucleos(t)ide analogs (NAs) combined with PEG-IFN-α2b in treating patients with chronic hepatitis B (CHB) through two different treatment regimens: continuous and pulsed therapy. It is a large-scale, multicenter, prospective study that will last up to 96 weeks, measuring various markers of hepatitis B infection at multiple time points to assess clinical cure rates and E antigen conversion rates. The goal is to determine which treatment strategy is more effective in achieving better outcomes for CHB patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 60 who have been HBsAg positive for more than 6 months and are currently on continuous NA therapy.
Not a fit: Patients with active hepatitis A, C, D, E, or HIV infections, or those with decompensated liver disease, are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for chronic hepatitis B, enhancing patient outcomes and potentially achieving higher cure rates.
How similar studies have performed: Previous studies have indicated potential benefits of pulsed therapy in similar contexts, but this specific approach is being evaluated for the first time in this large-scale setting.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hefei, Anhui
- The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (Recruiting)
Study contacts
- Study coordinator: Yufeng Gao, MD
- Email: aygyf@anmu.edu.cn
- Phone: 13956938032
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.