An observational study in Chronic Hepatitis B, sponsored by Huashan Hospital. Status unknown at 17 sites in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-10-28.
Sponsored by Huashan Hospital · Observational
This is a multicenter, prospective cohort study to evaluate the efficacy and safety of sequential combination or switch therapy of pegylated interferon alfa-2a in chronic hepatitis B patients with low HBsAg and HBeAg titers after long-term entecavir therapy, and compared to those who continued on ETV therapy.
Chronic hepatitis B (CHB) infection remains a global health treat. The ideal end point of therapy is HBsAg loss or HBsAg seroconversion, indicating a complete remission of CHB. In patients with HBeAg-positive CHB, sustained HBeAg seroconversion is also a desirable end point. Current therapies include pegylated interferon (PegIFN) finite and nucleos(t)ide analogues (NUCs) longterm therapy. However, only 30-40% of patients may achieve HBeAg seroconversion on PegIFN monotherapy, whereas 15-20% of patients on entecavir (ETV). Recently, accumulating evidence had shown that optimization of switching or combining PegIFN in patients on long-term ETV therapy may increase rate of HBeAg seroconversion and even lead to the complete eradication of HBV. However, these two regimens has not been tested adequately in patients with low HBsAg/HBeAg titers on long-term ETV therapy.
This is a multicenter, prospective cohort study to evaluate the efficacy and safety of sequential combination or switch therapy of pegylated interferon alfa-2a in chronic hepatitis B patients with low HBsAg and HBeAg titers after long-term entecavir therapy, and compared to those who continued on ETV therapy.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's planned enrollment of 294 is above the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →Huashan Hospital is the lead sponsor of 239 studies on the registry; 102 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Chronic Hepatitis B Patients with Low HBsAg and HBeAg Titers after Long-term Entecavir Therapy
Exclusion Criteria:
Patients who have been assigned to pegylated interferon alfa-2a.
Drug: Pegylated interferon alfa-2a
Patients who have been assigned to pegylated interferon alfa-2a plus entecavir.
Drug: Pegylated interferon alfa-2a plus Entecavir
Patients who have been assigned to entecavir monotherapy.
Drug: Entecavir
ETV 0.5mg oral daily plus PegIFN alfa-2a 180ug subcutaneous injection weekly for 8 weeks and followed by PegIFN alfa-2a 180ug subcutaneous injection weekly for 40 weeks
Also known as: PegIFN alpha-2a
ETV 0.5mg oral daily plus PegIFN alfa-2a 180ug subcutaneous injection weekly for 48 weeks
Also known as: PegIFN alpha-2a, ETV
ETV 0.5mg oral daily for 48 weeks
Also known as: ETV
Rate of HBeAg seroconversion
Loss of HBeAg and detection of anti-HBe antibodies
Time frame: week 72 (24 weeks after 48 weeks of treatment)
Rate of HBsAg loss
HBsAg loss with or without detection of anti-HBs antibodies
Time frame: week 72 (24 weeks after 48 weeks of treatment)
Rate of HBV DNA <20IU/mL
Time frame: week 72 (24 weeks after 48 weeks of treatment)
Rate of HBsAg seroconversion
Time frame: week 72 (24 weeks after 48 weeks of treatment)
Percentage of patients reaching a ≥ 1log10 decline of quantitative HBsAg
Time frame: week 72 (24 weeks after 48 weeks of treatment)
Decline of quantitative HBsAg from baseline
Time frame: week 72 (24 weeks after 48 weeks of treatment
This study is status unknown, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Huashan Hospital