A Phase 4 interventional study of peginterferon alfa-2a (40KD) [PEGASYS] in Hepatitis B, Chronic, sponsored by Hoffmann-La Roche. Terminated at 4 sites in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2008-06-30.
Sponsored by Hoffmann-La Roche · Phase 4, Interventional, and Treatment
This single arm study will evaluate the efficacy and safety of PEGASYS in patients with lamivudine resistant HBeAg negative chronic hepatitis B. Patients will receive PEGASYS 180 micrograms s.c. weekly for 48 weeks; following this, there will be a 48 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: peginterferon alfa-2a (40KD) [PEGASYS]
180 micrograms sc weekly for 48 weeks
Normalization of ALT, and HBV-DNA <10,000 copies/mL
Time frame: Week 96
Normalization of ALT, and HBV-DNA <10,000 copies/mL
Time frame: Weeks 48 and 72
HBsAg loss and anti-HBs seroconversion
Time frame: Weeks 48, 72 and 96
AEs and lab parameters
Time frame: Throughout study
This study is terminated, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche