Pegylated interferon treatment for chronic hepatitis B patients who previously received interferon
A Prospective, Multicenter, Non-randomized, Controlled Study to Pursuit Clinical Functional Cure of Pegylated Interferon α in Previously Interferon-treated Chronic Hepatitis B （Leading Study）
This study is testing if a new pegylated interferon treatment can help people with chronic hepatitis B who didn't get better with previous interferon therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2016 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06323681 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of pegylated interferon α-2b in patients with chronic hepatitis B (CHB) who have previously undergone interferon therapy but did not achieve a functional cure. It aims to enroll approximately 2000 participants who will be randomly assigned to receive either peginterferon-based therapy or nucleos(t)ide analogs (NAs) monotherapy for 48 weeks. The study seeks to confirm whether retreatment with peginterferon can lead to higher rates of HBsAg clearance compared to NAs alone, potentially reducing complications associated with CHB. Participants will be monitored for their response to treatment and overall health outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 who have previously received interferon therapy for chronic hepatitis B and have shown a good response but have not achieved a functional cure.
Not a fit: Patients who are pregnant, lactating, or have neuropsychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option that enhances the chances of achieving a functional cure for chronic hepatitis B.
How similar studies have performed: Previous studies have suggested that retreatment with interferon can be beneficial, indicating that this approach may have a foundation of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Understand and sign the informed consent, participate in the study voluntarily. * Aged between 18 and 65 (including 18 and 65). * HBsAg positive for at least 6 months or other evidence suggests chronic hepatitis B. * Had previously received interferon therapy, and discontinuation for at least 6 months at the time of enrollment, with a HBsAg level declined for at least 80% at the end of interferon treatment compared to the level of treatment started. * HBsAg≤500 IU/mL at screening, and HBsAg rebound should not exceed 50% when compared to the HBsAg level of previously interferon treatment started. * The pregnancy test within 24 hours previous to the first medication must be negative for women of childbearing. And all participants (male and female) should use effective contraception during the study period. Exclusion Criteria: * Pregnant or lactating women, or those who had a birth plan during the study period. * Patients with neuropsychiatric disorders, especially depression, anxiety, mania, schizophrenia and other mental illness history or family history of mental illness. * Patients with chronic liver disease caused by hepatitis A, hepatitis C, hepatitis E and/or HIV infection, or other causes (such as alcoholic hepatitis, drug-induced hepatitis, autoimmune liver disease, etc.). * Evidence of acute severe liver damage: ALT\>10 ULN, or markedly elevated ALT with significantly elevated bilirubin. * Evidence of uncompensated liver disease: ascites, esophageal and gastric varices rupture bleeding, sepsis, hepatic encephalopathy, hepatorenal syndrome, etc. Or previous evidence of decompensation of cirrhosis. * Patients with evidence of hepatocellular carcinoma or AFP\>1 ULN. * Kidney diseases: acute or chronic nephritis, renal insufficiency, nephrotic syndrome, etc. Or serum creatinine \>1 ULN at screening. * Neutrophil count \<1.5×10\^9/L, platelet count \<90×10\^9/L, blood phosphorus \< 0.8 mmol /L. * Autoimmune diseases (such as psoriasis, systemic erythematosus, etc.), endocrine system diseases (such as thyroid diseases, diabetes, etc.), hypertension (blood pressure ≥140/90 mmHg) poorly controlled by prescription drugs, serious history of heart disease (especially in the past 6 months), severe retinopathy or other serious eye diseases. Patients with organic disease or dysfunction of other vital organs. * Patients who plan to receive organ transplant or have already undergone organ transplant. * Patients who allergic to the investigational drug or any of its excipients, or who meet any contraindication declared in the instructions of the investigational drug. * Other conditions that are considered inappropriate for enrollment by the investigator.
Where this trial is running
Shanghai, Shanghai Municipality
- Department of Infectious Diseases , Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
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.