A Phase 4 interventional study of Peginterferon alfa-2a in Hepatitis B, Chronic, sponsored by Hoffmann-La Roche. Completed at 3 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Hoffmann-La Roche · Phase 4, Interventional, and Treatment
This is a study of the efficacy and safety of peginterferon alfa-2a (Pegasys) in naive, interferon- or lamivudine-pretreated participants with HBeAg-positive chronic HBV. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 307 is above 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:
Participants who never received any HBV treatment, will receive peginterferon alfa-2a (180 micrograms \[mcg\]) subcutaneously once weekly for 48 weeks.
Drug: Peginterferon alfa-2a
Participants who received conventional interferon treatment and had relapse or did not respond, will receive peginterferon alfa-2a (180 mcg) subcutaneously once weekly for 48 weeks.
Drug: Peginterferon alfa-2a
Participants who received lamivudine and had relapse or did not respond, will receive peginterferon alfa-2a (180 mcg) subcutaneously once weekly for 48 weeks.
Drug: Peginterferon alfa-2a
Peginterferon alfa-2a will be administered at a dose of 180 mcg subcutaneously once weekly for 48 weeks.
Also known as: Pegasys
Percentage of participants with HBV deoxyribonucleic acid (DNA) less than (<) 100,000 copies per milliliters (copies/mL)
Time frame: 72 weeks
Percentage of participants with HBeAg seroconversion
Time frame: 72 weeks
Number of participants who achieved HBV DNA levels below limit of detection
Time frame: Weeks 48 and 72
Number of participants with HBsAg loss
Time frame: Weeks 48 and 72
Number of participants with both Hepatitis B Surface Antigen (HBsAg) loss and presence of Anti-HBs
Time frame: Weeks 48 and 72
Number of participants with alanine aminotransferase (ALT) normalization
Time frame: Weeks 48 and 72
Number of participants with combined response (HBV DNA <100,000 copies/mL, HBeAg loss, and ALT normalization)
Time frame: Weeks 48 and 72
Incidence of adverse events
Time frame: up to 72 weeks
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche