NCT01623778

Optimization of Antiviral Therapy of Chronic HBV Infection

Observation Study of Different Optimized Therapy Method of Patients With Chronic Hepatitis B

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 67 (actual)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Australia Antigen Positive
• Hepatitis B
• Adverse Effects

Interventions

Type	Name	Description
DRUG	Interferon Alfa-2a add on ADV	Interferon add on ADV for 48 weeks

Timeline

• Start date: 2009-01-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2012-06-20
• Last updated: 2012-06-20

Locations

1 site across 1 country: China