Optimization of Antiviral Therapy of Chronic HBV Infection

Completed

• Conditions: Hepatitis B; Australia Antigen Positive; Adverse Effects
• Interventions: Drug: Interferon Alfa-2a add on ADV

• Registration Number: NCT01623778
• Lead Sponsor: Changhai Hospital

Brief 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.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-06
• Study First Submitted: 2012-06-16
• Study First Submitted QC: 2012-06-19
• Last Update Submitted: 2012-06-19
• Study First Posted: 2012-06-20
• Last Update Posted: 2012-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

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

• no decompensated cirrhosis,
• no hepatitis C, hepatitis D or human immunodeficiency virus (HIV) co-infection,
• no hepatocellular carcinoma and other tumors or history of severe hepatitis,
• no other systems diseases, such as a history of cardiopulmonary diseases, thyroid disorders, immune system disorders, epilepsy or mental illness (such as severe depression).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Add on ADV	Interferon Alfa-2a add on ADV	Patients with inadequate response to interferon at 24 weeks received interferon add on ADV optimized therapy
Switch to LDT	Interferon Alfa-2a add on ADV	Patients with inadequate response to interferon at 24 weeks received switching to LDT therapy

Primary Outcome Measures

Name	Time	Method
HBeAg seroconversion rate	48weeks

Secondary Outcome Measures

Name	Time	Method
HBV DNA decline	48weeks

Trial Locations

Locations (1)

Changhai hospital; 🇨🇳 Shanghai, Shanghai, China