Status:
UNKNOWN
Entecavir and Pegasys Sequential Therapy Versus Pegasys for HBeAg Negative Chronic Hepatitis B
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
National Science and Technology Council, Taiwan
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Currently, peginterferon alfa-2a or oral nucleos(t)ides are approved for the treatment with HBeAg negative CHB, with the overall ALT normalization and HBV viral suppression far from satisfactory. Ther...
Detailed Description
Chronic hepatitis B (CHB) is prevalent in the world, with estimated chronic carriers of 350 millions worldwide. Currently, peginterferon alfa-2a or oral nucleos(t)ides are approved for the treatment w...
Eligibility Criteria
Inclusion
- Chronic hepatitis B (presence of HBsAg \> 6 months) with anti-HBe persistence and abscence of HBeAg for more than 3 months
- Age older than 18 years
- HBV DNA \> 2,000 IU/mL for more than 2 occasions
- Serum ALT levels between 2 to 10 folds the upper limit of normal (ULN)
- A liver biopsy compatible with chronic hepatitis B
Exclusion
- Anemia (hemoglobin \< 13 gram per deciliter for men and \< 12 gram per deciliter for women)
- Neutropenia (neutrophil count \<1,500 per cubic milliliter)
- Thrombocytopenia (platelet \<90,000 per cubic milliliter)
- Co-infection with hepatitis B virus (HBV), hepatitis D virus (HDV) or human immunodeficiency virus (HIV)
- Chronic alcohol abuse (daily consumption \> 20 gram per day)
- Decompensated liver disease (Child-Pugh class B or C)
- Serum creatinine level more than 1.5 times the upper limit of normal
- Autoimmune liver disease
- Neoplastic disease
- An organ transplant
- Immunosuppressive therapy
- Poorly controlled autoimmune diseases, pulmonary diseases, cardiac diseases, psychiatric diseases, neurological diseases, diabetes mellitus
- Evidence of drug abuse
- Unwilling to have contraception
- Known allergic reaction to entecavir or peginterferon alfa-2a
- Unwilling to sign inform consent
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00917761
Start Date
February 1 2007
End Date
December 1 2013
Last Update
December 20 2012
Active Locations (6)
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1
National Taiwan University Hosptial, Yun-Lin Branch
Douliu, Taiwan
2
Taichung Veterans General Hospital
Taichung, Taiwan
3
National Taiwan University Hospital
Taipei, Taiwan, 10002
4
Buddhist Tzu Chi General Hospital
Taipei, Taiwan