NCT04035837Active, not recruitingPhase 4
The Clinical Cure Project of Chronic Hepatitis B in China
A Study of Peg-interferon Treatment for Nucleos(t)Ide Analogues Suppressed Chronic Hepatitis B Patients With Low Level Hepatitis Surface Antigen
Source: ClinicalTrials.gov · Last updated 13 Apr 2025
Brief summary (registry, in English)
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(s)ide analogues(NAs) for some period can achieve higher hepatitis B surface antigen(HBsAg) clearance rate(which is called clinical cure or functional cure) by using pegylated interferon. Patients who achieve clinical cure will further reduce liver inflammation, fibrosis and risks of liver cirrhosis and cancer in the future. This study was initiated in May 2018 and plans to recruit 30,000 eligible patients. The enrollment conditions are as follows: 1. according with the diagnosis of chronic hepatitis B in the guideline of China in 2015; 2.18-60 years old; 3. more than 1 year history of NAs therapy with HBsAg ≤1500 IU/ml, negative hepatitis e antigen and hepatitis B virus DNA\<100 IU/ml; 4. no contraindications of interferon. For the above patients, pegylated interferon was used for 1-2 years(combined with NAs for at least 3 months).The primary goal of this study is to find out the optimal treatment for clinical cure.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 30000 (estimated)
- First submitted
- 13 Jul 2019
- Start date
- 16 May 2018
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Diseases
- Hepatitis B
- NCT number
- NCT04035837
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 30000
- From 16 May 2018 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- existing or previous decompensated liver cirrhosis
- before or after transplantation
- alcohol or drug addicted
Other illness
- Allergy to interferon
- combined with autoimmune diseases, psychiatric diseases, diabetes or thyroidism
- confirmed or suspected malignant tumors
- infected by HIV
- any conditions that is unsuitable to interferon therapy according to the doctors' judgement
Lab values
- Alanine transaminase \>10 times of upper limit of normal(ULN) or total bilirubin \>2 times of ULN
- White blood cells or Platelet below the lower limit of normal
Other
- existing severe organ injury
- using immunosuppressor
- pregnant or having a planned parenthood in 2 years
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.