HBsAg Clearance of Peginterferon Treatment in Patients Who Had Chronic Hepatitis B and Were on the Treatment of Nucleoside(Acid) Analogues

Efficacy of Peginterferon Alpha 2a Therapy in Chronic Hepatitis B Patients Being Treated With Nucleoside(Acid) Analogues

Sponsors

Lead sponsor: Beijing Ditan Hospital

Source Beijing Ditan Hospital
Brief Summary

Antiviral therapy is the most important method to slow and stop the progress of the disease in patients with chronic hepatitis B (CHB). Nucleoside (acid) analogues (NA) can Effectively suppress HBV replication, but it should be continue used and relapse would happen in most patients after withdrawal of therapy. However, long-term use of NA could induce viral resistance mutation lead to loss of efficacy. Interferon treatment can enhance specific and non-specific immune function in chronic hepatitis B patients, make patients get immune control to HBV infection and obtain sustained response after treatment. Thus the CHB patients on the treatment of NA should be stop NA treatment after interferon treatment. In this study, the effects of interferon treatment in CHB patients who were on the NA treatment and obtained HBsAg level≤250 IU/ml.

Detailed Description

In this trial, patients who were CHB and treated with NA more than 6 months, still on the treatment and achieved HBsAg level ≤250 IU/ml with HBV DNA undetectable will be randomized enrolled into group A (Intervention group), in which patients switch to interferon therapy for 72 weeks, group B(control group), patients continue treated with NA for 72 weeks. Serum HBV DNA load, HBsAg/anti-HBs level, HBeAg/anti-HBe will be tested at enrollment and every 3 months during the treatment course. Parameters of Liver and kidney function, and liver ultrasound examination will be tested with intervals 1-3 months. The efficacies of interferon treatment were devalued by the rate of HBsAg clearance and decline of HBsAg levels on the 72 weeks of interferon treatment compared with control group.

Overall Status Unknown status
Start Date January 2013
Completion Date December 2016
Primary Completion Date December 2016
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
rate of HBsAg loss 72 weeks
Secondary Outcome
Measure Time Frame
decline of HBsAg level 72 weeks
Enrollment 200
Condition
Intervention

Intervention type: Drug

Intervention name: peginterferon alpha 2a

Description: in this group,patients will receive 180 ug of peginterferon alpha 2a injection weekly for 72 weeks

Arm group label: peginterferon alpha 2a

Other name: PEG-IFN a-2a

Eligibility

Criteria:

Inclusion Criteria:

- patients who were chronic hepatitis B and had achieved HBsAg level ≤250 IU/ml on treatment of Nucleoside (acid) Analogues

Exclusion Criteria:

- Active consumption of alcohol and/or drugs

- Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus

- History of autoimmune hepatitis

- Psychiatric disease

- Evidence of neoplastic diseases of the liver

Gender: All

Minimum age: 18 Years

Maximum age: 60 Years

Healthy volunteers: No

Overall Contact

Last name: Yao Xie, MD

Phone: 8610-84322489

Email: [email protected]

Location
facility status contact investigator Beijing Ditan hospital,Capital Medical University Yao Xie, doctor 8613501093293 [email protected] Yao Xie, doctor Principal Investigator
Location Countries

China

Verification Date

August 2016

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Beijing Ditan Hospital

Investigator full name: Yao Xie

Investigator title: liver diseases center

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: peginterferon alpha 2a

Arm group type: Experimental

Description: in this group, patients who were on treatment of Nucleoside (Acid) Analogues and had achieved HBsAg level ≤250 IU/ml will switch to treatment of peginterferon alpha 2a for 72 week.

Arm group label: control group

Arm group type: No Intervention

Description: in this group, patients who were on treatment of Nucleoside(Acid) Analogues and had achieved HBsAg level ≤250 IU/ml will be continue to treatment of Nucleoside(Acid) Analogues for 72 week.

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov