HBsAg Clearance in Inactive Chronic HBsAg Carriers After Interferon Treated

NCT ID: NCT01471535

Last Updated: 2015-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2012-12-31

Brief Summary

Hepatitis B surface antigen loss/seroconversion, considered to be the ideal outcome of chronic hepatitis B virus (HBV) infection, occurs spontaneously at a low rate in inactive carriers.

The researchers aim to investigate the ability of peginterferon alpha-2a to achieve surface antigen loss/seroconversion therapy in inactive carriers with persistently normal alanine aminotransferase (ALT) levels, undetectable HBV DNA and low surface antigen levels, who would not generally be considered candidates for therapy.

Detailed Description

Chronic HBV inactive carriers were enrolled in the out-patient department of Beijing Ditan Hospital. All of them were HBsAg positive and anti-HBs negative for more than 6 months with persistent undetectable HBV DNA and normal ALT levels measured at 3-6 monthly intervals during the preceding 2 years as well as with serum HBsAg levels ≤100 IU/mL determined on two occasions during the month prior to treatment. All patients did not have other liver diseases and contraindications for interferon therapy.

After giving informed consent, patients were treated with weekly subcutaneous injections of peginterferon alpha-2a 180 µg. The use of other immune suppressive or regulatory drugs and other antiviral drugs was prohibited during the course of the study.

In this study, the only parameter to assessing the treatment response was HBsAg level change. Treatment endpoint was HBsAg loss(<0.05 IU/mL) and anti-HBs positive(>10 mIU/mL) defined as seroconversion.

Depending on the decline of HBsAg level, treatment was either continued for a prolonged period until the endpoint was achieved, or terminated in case of nonresponse. Treatment was proceeded if HBsAg level continued to decline until HBsAg seroconversion was achieved and the anti-HBs level was above 200 mIU/ml. If the patients were not willing to extend treatment, the therapy was ended at the time of HBsAg loss, or stopped without further decline of HBsAg levels on three months treatment.

Liver function parameters, including ALT, aspartate aminotransferase (AST), albumin (ALB) and total bilirubin (Tbil) were examined using an automated biochemical analyzer. Peripheral blood neutrophil and platelet count were detected before treatment, and monitored during treatment with one to three month intervals, and base on the test results to adjust the next checking time. Quantitative HBV DNA testing was conducted using a commercially available real-time fluorescence quantitative PCR kit. HBsAg levels were quantified with Architect i2000 HBsAg quantitative assay (Abbott Laboratories) kit.

The main efficacy endpoints were HBsAg loss and seroconversion.

Conditions

Chronic Hepatitis B

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

peginterferon alpha 2a

the inactive chronic HBsAg carriers were treated with peginterferon alpha 2a for 72 weeks and followed for 24 weeks.

Group Type: EXPERIMENTAL

Pegylated interferon alfa-2a

Intervention Type: DRUG

patients were given peginterferon alfa-2a (40KD) (Pegasys®; Roche, Basel, Switzerland)180 µg by subcutaneous injection once weekly for 120 weeks

Interventions

Pegylated interferon alfa-2a

patients were given peginterferon alfa-2a (40KD) (Pegasys®; Roche, Basel, Switzerland)180 µg by subcutaneous injection once weekly for 120 weeks

Intervention Type: DRUG

Other Intervention Names

Pegasys®; Roche, Basel, Switzerland

Eligibility Criteria

Inclusion Criteria

• HBsAg positive and anti-HBs negative for more than 6 months
• HBeAg-negative/anti-HBe-positive
• Persistently undetectable HBV DNA with normal ALT levels, as established at 3-6 monthly intervals during the preceding 2 yrs
• Serum HBsAg levels ≤100 IU/mL, as determined on two occasions during the month prior to treatment
• Absence of previous antiviral therapy

Exclusion Criteria

• With active alcohol and/or drugs consumption
• With human immunodeficiency virus or hepatitis C virus coinfections
• With clinical evidence of cirrhosis
• With history of autoimmune hepatitis
• With hematological or psychiatric diseases
• With evidence of neoplastic diseases
• With severe cardiac or pulmonary disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Ditan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yao Xie

Director of division 4, liver diseases center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yao Xie, phD/MD

Role: PRINCIPAL_INVESTIGATOR

Liver diseases center, Beijing Ditan Hospital

Locations

liver disease center, Beijing Ditan Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

DTH-XY002

Identifier Type: -

Identifier Source: org_study_id