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

• Status: Unknown status
• Trial end date: 2019-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
• Collaborators: First People's Hospital of Foshan; First People's Hospital, Shunde China; Huazhong University of Science and Technology; Huizhou Municipal Central Hospital; Nanchang University; Peking University; Shenzhen Third People's Hospital; Tang-Du Hospital; The First Affiliated Hospital of Kunming Medical College; Yuebei People's Hospital
• Treatments: Peginterferon alfa-2a; Peginterferon alfa-2b

Criteria

Inclusion Criteria:

1. CHB patients who had received NAs for more than 12 months.

2. Hepatitis B e antigen (HBeAg)-negative and anti-HBeAg positive.

3. Hepatitis B surface antigen (HBsAg) positive and <1500 IU/mL.

4. Hepatitis B virus DNA not detectable(Roche Cobas).

Exclusion Criteria:

1. Patients with liver cirrhosis, Hepatocellular Carcinoma 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 who can't come back to clinic for follow-up on schedule.