HBsAg Clearance in Inactive Chronic HBsAg Carriers After Interferon Treated

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Ditan Hospital
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a

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