An observational study in Australia Antigen Positive, Hepatitis B and Adverse Effects, sponsored by Changhai Hospital. Completed at 1 site in China. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-06-20.
Sponsored by Changhai Hospital · Observational
Along with the improvement of the accuracy of detection of HBV serological markers, the optimization of antiviral therapy for patients with chronic hepatitis B (CHB) infection becomes feasible. Currently, the recommendation of optimized treatment especially interferon therapy are mainly based on retrospective studies, it still lacks prospective evidence. This study is aimed to evaluate the efficacy, safety and pharmacoeconomics benefits of 48 weeks optimized interferon therapy (switch to telbivudine or plus adefovir dipivoxil) for HBeAg positive CHB with inadequate response to 24 weeks interferon treatment.
Patients with inadequate response to interferon therapy at 24 weeks were enrolled in this study and accepted the optimized therapy (add on ADV or switch to LDT) for 48weeks. All these patients were followed for 48 weeks and the HBeAg seroconversion and HBV DNA level were observed. Safety and the economic effect of the two optimized therapy methods also were observed.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 67 is below the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →Changhai Hospital is the lead sponsor of 342 studies on the registry; 133 are open to participants now.
Counted across the registry records on this site, refreshed daily.
cases of HBeAg-positive CHB with inadequate response to 24 weeks Peg interferon alpha-2a were enrolled.
patients receiving Peg interferon α-2a with inadequate response at 24 weeks (HBeAg titer ≥ 100Paul Ehrlich Institute Unit (PEIU)/ml and HBV DNA ≥ 5.0 Log copies/ml or HBV DNA titer decline \<1 Log copies/ml) were enrolled into this study.
Exclusion Criteria:
Patients with inadequate response to interferon at 24 weeks received interferon add on ADV optimized therapy
Drug: Interferon Alfa-2a add on ADV
Patients with inadequate response to interferon at 24 weeks received switching to LDT therapy
Drug: Interferon Alfa-2a add on ADV
Interferon add on ADV for 48 weeks
Also known as: Response guild treatment, optimized therapy, Chronic HBV infection
HBeAg seroconversion rate
Time frame: 48weeks
HBV DNA decline
Time frame: 48weeks
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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Changhai Hospital