New Strategy Study of Functional Cure of Chronic Hepatitis B

Sun Yat-sen University

Status: Unknown

Conditions: Hepatitis B, Chronic

Treatments: Drug: Peginterferon alfa-2b

Study type: Interventional

Funder types: Other

Identifiers

NCT02605252

3rd-sysu-hbv-functional cure

Details and patient eligibility

About

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-2b and NAs.

Full description

CHB Patients who had received, and responded to, NAs for more than 12 months are switched to receive peginterferon alfa-2b 80 micrograms/week for 48 weeks and follow up for 48 weeks.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

CHB patients

Experimental group

Description:

Hepatitis B e antigen (HBeAg)-negative CHB patients who had received NAs for more than 12 months, with HBsAg \<1500 IU/ mL and Hepatitis B virus DNA not detectable, are to receive peginterferon alfa-2b 80 micrograms/week for 48 weeks.

Treatment:

Drug: Peginterferon alfa-2b