Status:
COMPLETED
48 Weeks Combination Therapy for Patients With HBeAg-negative Chronic Hepatitis B Virus (HBV) Infection
Lead Sponsor:
Foundation for Liver Research
Conditions:
Hepatitis B
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to investigate whether in patients with chronic HBeAg-negative hepatitis B, PEG-IFN-ribavirin combination therapy for 1 year leads to enhanced response (HBV DNA \<10E4 cop...
Detailed Description
Despite the introduction of newer drugs for the treatment of chronic hepatitis B, there is still no optimal treatment. Pegylated interferon alfa has proven sustained efficacy in approximately 30-40% o...
Eligibility Criteria
Inclusion
- Chronic hepatitis B
- Biopsy performed within one year prior to screening or during screening
- ALT \> 1.5 x ULN
- HBeAg negative, anti-HBeAg positive
- HBV DNA \> 10E5 copies/ml
- Age 18-70 years
- Written informed consent
- Hepatic imaging without evidence of HCC
- All fertile males and females must be using two forms of effective contraception
Exclusion
- Antiviral therapy against HBV within the previous 6 months; treatment with any investigational drug within 30 days of entry to this protocol
- Severe hepatitis activity as documented by ALT \> 10 x ULN
- Advanced liver disease
- Pre-existent leucopenia or thrombopenia
- Co-infection with HCV,HDV or HIV
- Other acquired or inherited causes of liver disease
- Alpha fetoprotein \> 50 ng/ml.
- Evidence of severe renal disease
- Hyper- or hypothyroidism
- Significant cardiovascular or pulmonary dysfunction, malignancy,immunodeficiency syndromes
- Immune suppressive treatment within the previous 6 months
- Contra-indications for alpha-interferon therapy
- Pregnancy, breast-feeding
- Any medical condition requiring chronic systemic administration of steroids
- Substance alcohol or drug abuse
- Subjects with clinically significant retinal abnormalities
- Subjects with clinically significant hearing abnormalities
- Hemoglobinopathies
- Subjects with known hypersensitivity to ribavirin
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT00114361
Start Date
March 1 2005
End Date
April 1 2010
Last Update
June 22 2010
Active Locations (1)
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1
Erasmus MC department hepatology
Rotterdam, Netherlands, 3000CA