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NCT Number: NCT01623778

Optimization of Antiviral Therapy of Chronic HBV Infection

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.

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Key information

Conditions

Australia Antigen Positive Adverse Effects Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Changhai hospital

Shanghai, Shanghai Municipality, 200433, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Interferon Alfa-2a add on ADV

Drug

Interferon add on ADV for 48 weeks

Other names: Response guild treatment, optimized therapy, Chronic HBV infection

Primary outcomes

  1. HBeAg seroconversion rate

    Time frame: 48weeks

Secondary outcomes

  1. HBV DNA decline

    Time frame: 48weeks

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 20, 2012
Registry last updated
Jun 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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