A Study of Peginterferon Alfa-2a [PEGASYS] in Patients With Chronic Hepatitis B Who Are HBeAg Positive
Status and phase
Conditions
Treatments
Details and patient eligibility
About
This open-label, multi-center study will evaluate the effect on the quantitative HBsAg reduction of peginterferon alfa-2a [PEGASYS] in patients with HBeAg positive chronic hepatitis B. Patients will receive PEGASYS 180 mcg sc once weekly. After 24 weeks of treatment, rapid responders will receive another 24 weeks of treatment. After 24 weeks of treatment, slow responders will be randomized to another 24 or 72 weeks of PEGASYS monotherapy, or to 72 weeks PEGASYS plus 36 weeks adefovir (10 mg, po once daily, starting from week 29 of PEGASYS treatment). The anticipated time on study drug is >2 years.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Adult patients >/=18 years of age
- HBeAg positive chronic hepatitis B
- Compensated liver disease
Exclusion criteria
- Patients who had previously received treatment of drugs with activity against HBV within 6 months prior to study start
- Antiviral, anti-neoplastic or immunomodulatory treatment
- Co-infection with active hepatitis A, hepatitis C, hepatitis D, or HIV
- Evidence of decompensated liver disease
- Chronic liver disease other than viral hepatitis
Trial design
Primary purpose
Allocation
Interventional model
Masking
265 participants in 4 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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