Optimization of Antiviral Therapy of Chronic HBV Infection

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01623778

Enrollment

Registered

2012-06-20

Start date

2009-01-31

Completion date

2011-12-31

Last updated

2012-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Effects, Australia Antigen Positive, Hepatitis B

Keywords

HBeAg seroconversion, Peginterferon alfa-2a, chronic hepatitis B(CHB, Optimal therapy, Response guild treatment(RGT);

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.

Interventions

DRUGInterferon Alfa-2a add on ADV

Interferon add on ADV for 48 weeks

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to 65 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame
HBeAg seroconversion rate	48weeks

Secondary

Measure	Time frame
HBV DNA decline	48weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026