The Optimizing Treatment of PegIFN Alfa in HBeAg-negative CHB Patients With Low Level HBsAg

The Optimizing Treatment of PegIFN Alfa in HBeAg-negative Chronic Hepatitis B Patients With Low Level HBsAg

As HBsAg clearance is uncommon in chronic hepatitis B (CHB) patients on nucleoside analogues (NAs) therapy. The purpose of this study is to optimize HBsAg clearance in CHB Patients with sequential treatment of pegylated interferon alpha and NAs.

Study Overview

• Status: Unknown
• Conditions: Chronic Hepatitis B
• Intervention / Treatment: Drug: peginterferon alfa; Drug: Nucleoside analogues

Detailed Description

In order to optimize HBsAg clearance in CHB patients with low level HBsAg, the investigators enrolled patients who had received, and responded to, NAs for more than 12 months(see the inclusion criteria), and patients are switched to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week. The longest course of treatment is 96 weeks. After treatment, patients will be followed up for 24 weeks. During the 96 weeks course of treatment, HBsAg level will be monitored. When HBsAg level is less than 0.05 IU/mL, peginterferon treatment will be stopped and patients will receive 24 weeks follow up.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • Recruiting
      • The Third Affiliated Hospital of Sun Yat-Sen University
      • Contact: Xiang Zhu, Doctor; Phone Number: 13826452564; Email: 0628zhuxiang@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. CHB patients who had received single NAs for more than 12 months.
2. Hepatitis B e antigen (HBeAg)-negative.
3. Hepatitis B surface antigen (HBsAg) positive and <1000 IU/mL.
4. Hepatitis B virus DNA <100 IU/mL.

Exclusion Criteria:

1. Patients with liver cirrhosis, Hepatocellular Carcinoma or AFP >2 ULN or other malignancies.
2. Patients with other factors causing liver diseases.
3. Pregnant and lactating women.
4. Patients with concomitant HIV infection or congenital immune deficiency diseases.
5. Patients with diabetes, autoimmune diseases.
6. Patients with important organ dysfunctions.
7. Patients with serious complications (e.g., infection, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding.)
8. Patients who receive antineoplastic or immunomodulatory therapy in the past 12 months.
9. Patients with a previous use of IFN anti hepatitis B virus treatment or have NAs drug resistance.
10. Patients who can't come back to clinic for follow-up on schedule.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; CHB patients with low level HBsAg.Hepatitis B e antigen (HBeAg)-negative CHB patients who had received NAs for more than 12 months, with HBsAg <1000 IU/mL and Hepatitis B virus DNA <100 IU/mL, are to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week. The longest course of treatment is 96 weeks. After treatment, patients will be followed up for 24 weeks. During the 96 weeks course of treatment, HBsAg level will be monitored. When HBsAg level is less than 0.05 IU/mL, peginterferon treatment will be stopped and patients will receive 24 weeks follow up.	Drug: peginterferon alfa; peginterferon alfa-2b or peginterferon alfa-2a
Other: Control; Patients do not need to change their NAs treatment.	Drug: Nucleoside analogues; Nucleoside analogues; Other Names: NAs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HBsAg Clearance	Percentage of Participants with HBsAg <0.05 IU/mL.	120 weeks
HBsAg Seroconversion	Percentage of Participants with HBsAg <0.05 IU/mL and anti-HBsAg positive.	120 weeks

Collaborators and Investigators

• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
• Collaborators: Peking University; First People's Hospital of Foshan; Shenzhen Third People's Hospital
• Investigators: Principal Investigator: Zhiliang Gao, Doctor, Third Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: July 16, 2016
• First Submitted That Met QC Criteria: July 16, 2016
• First Posted (Estimate): July 20, 2016

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 12, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Chronic Hepatitis B; peginterferon alfa
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic; Hepatitis, Chronic
• Other Study ID Numbers: I-Cure-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED