Trial | NCT02745704  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    200
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.
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 for 48 weeks and follow up for 24 weeks.
Study Started
Apr 30
2016
Primary Completion
Apr 30
2019
Anticipated
Study Completion
Apr 30
2019
Anticipated
Last Update
Jan 15
2019

Drug Peginterferon alfa

peginterferon alfa-2b 80 micrograms/week or peginterferon alfa-2a 180 micrograms/week

PEG-IFN group Experimental

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-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 48 weeks.

NAs group No Intervention

Patients do not need to change their NAs treatment.

Criteria 

Inclusion Criteria:

CHB patients who had received NAs for more than 12 months.
Hepatitis B e antigen (HBeAg)-negative and anti-HBeAg positive.
Hepatitis B surface antigen (HBsAg) positive and <1500 IU/mL.
Hepatitis B virus DNA not detectable(Roche Cobas).

Exclusion Criteria:

Patients with liver cirrhosis, Hepatocellular Carcinoma or other malignancies.
Patients with other factors causing liver diseases.
Pregnant and lactating women.
Patients with concomitant HIV infection or congenital immune deficiency diseases.
Patients with diabetes, autoimmune diseases.
Patients with important organ dysfunctions.
Patients with serious complications (e.g., infection, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding.)
Patients who receive antineoplastic or immunomodulatory therapy in the past 12 months.
Patients who can't come back to clinic for follow-up on schedule.
No Results Posted