Status:
COMPLETED
Efficacy Study of Thymosin alpha1 & Pegylated Interferon-alpha2a to Treat Chronic Hepatitis B
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Roche Pharma AG
SciClone Pharmaceuticals
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine the optimal treatment duration of antiviral therapy for chronic hepatitis B.
Detailed Description
Thymosin alpha1/interferon combination therapy has been known as an effective antiviral therapy for chronic hepatitis B. It is superior to interferon single therapy since the sustained viral response ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00291616
Start Date
December 1 2005
End Date
August 1 2008
Last Update
July 21 2011
Active Locations (1)
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1
Seoul National University Hospital
Seoul, Chongno-gu, South Korea, 110-744