Status:
UNKNOWN
A Study of Switch From Nucleotide to Peginterferon Alfa-2a in CHB Patients Achieving HBeAg Loss and HBV DNA <200IU/ml
Lead Sponsor:
The Second Affiliated Hospital of Chongqing Medical University
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
A Randomized, open-label, multicenter study. The patients after 1-3 years NAs treatment and having achieved HBeAg loss and HBV DNA \<200IU/ml will be switched to Pegasys for 48 or 96 weeks (with a 12...
Detailed Description
eligibility criteria: Men and women old of 18 to 65 years with chronic hepatitis B HBeAg positive treated with nucleoside and/or nucleotide analogues for 1-2 years and with partial response (HBeAg los...
Eligibility Criteria
Inclusion
- Patients on-treatment with NAs (ADV, ETV or LAM) for 1-3 years, having achieved HBeAg loss at screening, and HBV DNA \<200IU/ml for at least 48 weeks
- Male and female patients ≥ 18 to 65 years of age
- Chronic hepatitis B (positive HBsAg for at least 6 months prior to NA therapy start)
- Compensated liver disease (Child-Pugh \<6)
- Absence of hepatocellular carcinoma on liver imaging and/or alfa fetoprotein \< 50 ng/ml
- Negative urine or blood pregnancy test for women of childbearing potential within 24 hours of first PEG IFN study medication administration
- Able and willing to provide informed consent and abide by the requirements of the study
Exclusion
- Neutrophil count \<1.5 x 109cells/L or platelet count \<90 x 109cells/L
- Co-infections with HIV, HAV, HCV, HDV or HEV
- Women with ongoing pregnancy or breast feeding, or wishing to become pregnant during the study period
- Prolonged and excessive alcohol intake (\> 40g/day for men and \> 30g/day for women)
- Active intravenous drug abuse
- History or current treatment with telbivudine
- Treatment with immunomodulators (e.g. Interferon) for less than one year before study enrollment
- Treatment with immunosuppressors (including systemic corticosteroids) or anti-neoplastic treatment (including radiation therapy) \<=6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
- Serum concentrations of ceruloplasmin or alfa-antitrypsin consistent with an increased risk of metabolic disease
- History or other evidence of chronic pulmonary disease associated with functional limitation
- History of severe cardiac disease
- History of the severe seizure disorder or current anticonvulsivant use
- History of thyroid disease poorly controlled on prescribed medications. Patients with elevated thyroid stimulating hormone concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease
- History or other evidence of severe retinopathy
- History of autoimmune disease or presence of a significant level of auto-antibodies
- Renal insufficiency (creatinine clearance of \< 50 ml/min according to the Cockroft and Gault equation), kidney transplant, hemodialysis
- History of depression or uncontrolled psychiatric disorders
- Subjects protected by law or not in a position to give consent
- Patients with reproductive potential not willing to use an effective method of contraception.
- Evidence of an active or suspected cancer or a history of malignancy (other than basocellular carcinoma or in-situ cervical carcinoma)
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01464281
Start Date
October 1 2011
End Date
December 1 2016
Last Update
November 3 2011
Active Locations (1)
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1
The 2nd affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400010