Status:
ACTIVE_NOT_RECRUITING
The Clinical Cure Project of Chronic Hepatitis B in China
Lead Sponsor:
Third Affiliated Hospital, Sun Yat-Sen University
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
Chronic hepatitis B is a global public health problem, with nearly 700,000 deaths each year because of hepatitis B-related diseases. Recent studies have found that some patients who have used nucleot(...
Eligibility Criteria
Inclusion
- according with the diagnosis of chronic hepatitis B in the guideline of China in 2015
- 18-60 years old
- more than 1 year history of nucleot(s)ide analogues therapy with HBsAg ≤1500 IU/ml, negative HBeAg and HBV DNA\<100 IU/ml
- no contraindications of interferon
Exclusion
- Allergy to interferon
- Alanine transaminase \>10 times of upper limit of normal(ULN) or total bilirubin \>2 times of ULN
- existing or previous decompensated liver cirrhosis
- White blood cells or Platelet below the lower limit of normal
- existing severe organ injury
- combined with autoimmune diseases, psychiatric diseases, diabetes or thyroidism
- confirmed or suspected malignant tumors
- before or after transplantation
- using immunosuppressor
- pregnant or having a planned parenthood in 2 years
- alcohol or drug addicted
- infected by HIV
- any conditions that is unsuitable to interferon therapy according to the doctors' judgement
Key Trial Info
Start Date :
May 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
30000 Patients enrolled
Trial Details
Trial ID
NCT04035837
Start Date
May 16 2018
End Date
June 30 2026
Last Update
April 13 2025
Active Locations (1)
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1
Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630