Treatment for inactive chronic hepatitis B patients
Real World Study of Peginterferon Alpha-2b Treatment for Inactive Chronic Hepatitis B Patients: E-Cure Study
This study is testing if a new treatment called Peginterferon Alfa-2B can help adults with inactive chronic hepatitis B achieve a functional cure.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 5000 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Third Affiliated Hospital, Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05182463 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of Peginterferon Alfa-2B in patients with inactive chronic hepatitis B (CHB) to assess its effectiveness in achieving a functional cure. The study focuses on individuals aged 18-60 who have been HBsAg positive for over six months and meet specific criteria regarding their HBV DNA levels and liver enzyme levels. The trial aims to address the lack of consensus in current guidelines regarding antiviral therapy for this patient population. Participants will be monitored for their response to treatment and any potential side effects.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-60 with inactive chronic hepatitis B who have not previously received antiviral therapy.
Not a fit: Patients with liver cirrhosis, co-infections with other hepatitis viruses, or serious organ lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a functional cure for patients with inactive chronic hepatitis B, potentially reducing the risk of liver disease progression.
How similar studies have performed: Other studies have explored antiviral treatments for chronic hepatitis B, but the specific use of Peginterferon in inactive cases is less common, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-60, no gender limitation * HBsAg is positive for more than 6 months * Hepatitis B e antigen(HBeAg) is negative and anti-HBe is positive * Serum HBV DNA is less than 2000 IU/mL * Alanine aminotransferase(ALT) and/or Aspartate aminotransferase(AST) is normal * No antiviral durg (including nucleos(t)ide analogue and interferon) was used before enrollment * Good compliance and voluntarily signed informed consent Exclusion Criteria: * Allergic to pegylated interferon α-2b * Any indication of liver cirrhosis * Coinfection with hepatitis A virus(HAV), hepatitis C virus(HCV), hepatitis D virus(HDV), hepatitis E virus(HEV) or human immunodeficiency virus(HIV) * Combined with other liver diseases (including drug-related, alcoholic, autoimmune, genetic metabolic liver diseases, etc.) * There are serious lesions in the important organs, such as heart, lung, kidney, brain and fundus * Patients with autoimmune diseases, unstable diabetes or thyroid diseases(hyperthyroidism or hypothyroidism) * Confirmed or suspected liver cancer or other malignant tumors * Patients after or preparing for organ transplantation * Peripheral blood white blood cell count \< 3.5×109/L and/or platelet count \< 80×109/L * Under immunosuppressant treatment * Pregnant or planned pregnancy in a short term or lactation patients * Alcohol abuse (average alcohol intake is more than 40 g/d in males or 20g/d in women) or drug addicts * Present or past history of mental or psychological diseases * Other conditions that the investigators deem inappropriate for the study.
Where this trial is running
Guangzhou, Guangdong
- Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Guizhou Zou — The Second Hospital of Anhui Medical University
- Study coordinator: Zhishuo Mo, Master
- Email: vbstone@126.com
- Phone: +86 13632434363
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.