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

Chronic Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02838810
• Other study ID #: I-Cure-2
• Status: Recruiting
• Phase: Phase 4
• Start date: June 2016
• Est. completion date: December 2019

Study information

• Verified date: January 2019
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Xiang Zhu, Doctor
• Phone: 13826452564
• Email: 0628zhuxiang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• peginterferon alfa
peginterferon alfa-2b or peginterferon alfa-2a
• Nucleoside analogues
Nucleoside analogues

Locations

Country	Name	City	State
China	The third affiliated hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (4)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University	First People's Hospital of Foshan, Peking University, Shenzhen Third People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBsAg Clearance	Percentage of Participants with HBsAg <0.05 IU/mL.	120 weeks
Primary	HBsAg Seroconversion	Percentage of Participants with HBsAg <0.05 IU/mL and anti-HBsAg positive.	120 weeks