Real World Study of Peginterferon Alpha-2b Treatment for Inactive Chronic Hepatitis B Patients: E-Cure Study

Who is this study for? Patients with inactive chronic hepatitis B
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

There are about 400 million chronic hepatitis B virus (HBV) infection patients worldwide, posing a serious threat to global public health security. In China, HBV infection occured mainly in the perinatal period or infants, and about 10% of patients in the immune tolerance stage spontaneously transit to the immune clearance stage every year and become HBeAg-negative chronic HBV infection, resulting in a significant increase in the number of inactive chronic hepatitis B (CHB) patients. In recent years, different guidelines have not reached consensus on the need to initiate antiviral therapy for inactive CHB patients: In the guidelines of Asian Pacific Association for The Study of Liver(APASL)-2015 and American Association for the Study of Liver Diseases(AASLD)-2018, antiviral therapy is generally not recommended for this group of patients, and regular outpatient follow-up is recommended. Guideline of European Association for the Study of the Liver(EASL)-2017 suggests that people with a family history of cirrhosis and liver cancer at this stage could be treated with antiviral therapy even if they did not meet the indications of antiviral therapy. According to Guidelines for the Prevention and Treatment of Chronic Hepatitis B (version 2019) of China, antiviral therapy is still recommended for some patients with inactive HBsAg carrier status who are HBV DNA positive and meet the treatment indications. Studies have shown that some patients in immune tolerance stage may enter the immune clearance stage and have hepatitis flare. Patients of inactive CHB have the potential to develop HBeAg-negative CHB, and studies of long-term follow-up in this population have indicated the risk of hepatocellular carcinoma. With the popularization of the concept of functional cure for chronic hepatitis B, more and more people with inactive CHB have a strong desire for treatment. In recent years, several studies have demonstrated that Pegylated-interferon therapy can achieve high functional cure rate in patients with inactive CHB. The purpose of this study is to establish a national multi-center, prospective real world study to compare the efficacy of different antiviral treatment regimens for patients with inactive CHB and seek for the factors of functional cure.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Zhishuo Mo, Master
vbstone@126.com
+86 13632434363
Time Frame
Start Date: 2022-01-08
Estimated Completion Date: 2029-11-30
Participants
Target number of participants: 5000
Treatments
Experimental: Sequential Combination Group
Oral nucleos(t)ide analogues (NAs) (Entecavir(ETV), Tenofovir disoproxil fumarate tablets(TDF) or Tenofovir Alafenamide Fumarate(TAF)) is used for 12-24 weeks, followed by combination therapy with peginterferon α-2b. The Maximum course is 96 weeks. Follow-up period is 144 weeks.
Experimental: Initial Combination Group
NAs combined with peginterferon are used for 12-24 weeks, followed by peginterferon α-2b. The Maximum course is 96 weeks. Follow-up period is 144 weeks.
Experimental: Whole-course Combination Group
NAs combined with peginterferon are used for a maximum course of 96 weeks. Follow-up period is 144 weeks.
Experimental: Peginterferon Monotherapy Group
Peginterferon is used for a maximum course of 96 weeks. Follow-up period is 144 weeks.
Experimental: NAs Monotherapy Group
NAs is used for a maximum course of 96 weeks. Follow-up period is 144 weeks.
Related Therapeutic Areas
Sponsors
Leads: Third Affiliated Hospital, Sun Yat-Sen University

This content was sourced from clinicaltrials.gov