Efficacy Study of Thymosin alpha1 & Pegylated Interferon-alpha2a to Treat Chronic Hepatitis B

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the optimal treatment duration of antiviral therapy for chronic hepatitis B.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborators: Roche Pharma AG; SciClone Pharmaceuticals
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; Thymalfasin

Criteria

Inclusion Criteria:

• HBsAg positive and anti-HBs negative for more than 6 months

• HBeAg positive

• HBV DNA titer more than 100,000 IU/mL

• serum ALT more than upper normal limit value, but no more than 10 times upper normal limit value

Exclusion Criteria:

• the history of antiviral therapy for chronic hepatitis B within the recent 6 months

• HAV IgM Ab + and/or HCV Ab + and/or HDV Ab and/or HIV Ab +

• the sign of decompensated liver disease

• the history of hemoglobinopathy, autoimmune hepatitis, alcoholic liver disease

• pregnant or lactating woman

• neutrophil count less than 1,500/mm3 or platelet count less than 90,000/mm3

• serum creatinine more than 1.5 times upper normal limit value

• the sign of alcoholic or drug addiction within the recent 1 year

• the history of psychotic disorder especially like depression

• immunologically mediated disease

• the history of esophageal varix

• the history of severe heart disease or respiratory disease

• the history of severe epilepsy or current use of antiepileptic drug

• the sign of malignancy or suggestive of malignancy or the history of malignancy, the recurrence rate within 2 years of which is more than 20%

• the history of systemic anticancer treatment including radiation therapy or immunotherapy including systemic corticosteroid

• the history of major organ transplantation

• the history of medically uncontrolled thyroid disease

• the history or sign of severe retinopathy