The Clinical Cure Project of Chronic Hepatitis B in China

Hepatitis B, Chronic Clinical Trial

Official title:

A Study of Peg-interferon Treatment for Nucleos(t)Ide Analogues Suppressed Chronic Hepatitis B Patients With Low Level Hepatitis Surface Antigen

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04035837
• Other study ID #: ZhuFeng Project
• Status: Recruiting
• Phase: Phase 4
• Start date: May 16, 2018
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2023
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Zhishuo Mo
• Phone: +86 13632434363
• Email: vbstone[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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(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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30000
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• pegylated interferon-alfa
All the patients in this study will receive pegylated interferon for all course.

Locations

Country	Name	City	State
China	Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (10)

Brunetto MR. A new role for an old marker, HBsAg. J Hepatol. 2010 Apr;52(4):475-7. doi: 10.1016/j.jhep.2009.12.020. Epub 2010 Jan 30. No abstract available. — View Citation

Dietary effects on diurnal variation in lipogenesis. Nutr Rev. 1987 May;45(5):157-8. doi: 10.1111/j.1753-4887.1987.tb06353.x. No abstract available. — View Citation

European Association For The Study Of The Liver. EASL clinical practice guidelines: Management of chronic hepatitis B virus infection. J Hepatol. 2012 Jul;57(1):167-85. doi: 10.1016/j.jhep.2012.02.010. Epub 2012 Mar 20. No abstract available. Erratum In: J Hepatol. 2013 Jan;58(1):201. Janssen, Harry [corrected to Janssen, Harry L A]. — View Citation

Fattovich G, Bortolotti F, Donato F. Natural history of chronic hepatitis B: special emphasis on disease progression and prognostic factors. J Hepatol. 2008 Feb;48(2):335-52. doi: 10.1016/j.jhep.2007.11.011. Epub 2007 Dec 4. — View Citation

Liaw YF, Chu CM. Hepatitis B virus infection. Lancet. 2009 Feb 14;373(9663):582-92. doi: 10.1016/S0140-6736(09)60207-5. — View Citation

Liu J, Lee MH, Batrla-Utermann R, Jen CL, Iloeje UH, Lu SN, Wang LY, You SL, Hsiao CK, Yang HI, Chen CJ. A predictive scoring system for the seroclearance of HBsAg in HBeAg-seronegative chronic hepatitis B patients with genotype B or C infection. J Hepatol. 2013 May;58(5):853-60. doi: 10.1016/j.jhep.2012.12.006. Epub 2012 Dec 13. — View Citation

Moucari R, Korevaar A, Lada O, Martinot-Peignoux M, Boyer N, Mackiewicz V, Dauvergne A, Cardoso AC, Asselah T, Nicolas-Chanoine MH, Vidaud M, Valla D, Bedossa P, Marcellin P. High rates of HBsAg seroconversion in HBeAg-positive chronic hepatitis B patients responding to interferon: a long-term follow-up study. J Hepatol. 2009 Jun;50(6):1084-92. doi: 10.1016/j.jhep.2009.01.016. Epub 2009 Mar 9. — View Citation

Ning Q, Han M, Sun Y, Jiang J, Tan D, Hou J, Tang H, Sheng J, Zhao M. Switching from entecavir to PegIFN alfa-2a in patients with HBeAg-positive chronic hepatitis B: a randomised open-label trial (OSST trial). J Hepatol. 2014 Oct;61(4):777-84. doi: 10.1016/j.jhep.2014.05.044. Epub 2014 Jun 7. — View Citation

Thompson AJ, Nguyen T, Iser D, Ayres A, Jackson K, Littlejohn M, Slavin J, Bowden S, Gane EJ, Abbott W, Lau GK, Lewin SR, Visvanathan K, Desmond PV, Locarnini SA. Serum hepatitis B surface antigen and hepatitis B e antigen titers: disease phase influences correlation with viral load and intrahepatic hepatitis B virus markers. Hepatology. 2010 Jun;51(6):1933-44. doi: 10.1002/hep.23571. — View Citation

Tseng TC, Liu CJ, Su TH, Wang CC, Chen CL, Chen PJ, Chen DS, Kao JH. Serum hepatitis B surface antigen levels predict surface antigen loss in hepatitis B e antigen seroconverters. Gastroenterology. 2011 Aug;141(2):517-25, 525.e1-2. doi: 10.1053/j.gastro.2011.04.046. Epub 2011 Apr 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hepatitis B surface antigen	hepatitis B surface antigen should be tested by the reagents from Roche or Abbott, which is expressed by using IU/ml.	up to 48 weeks
Secondary	hepatitis B surface antibody	hepatitis B surface antigen should be tested by the reagents from Roche or Abbott, which is expressed by using IU/ml.	up to 48 weeks