Optimization of Antiviral Therapy of Chronic HBV Infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LiangXS, Changhai Hospital
ClinicalTrials.gov Identifier:
NCT01623778
First received: June 16, 2012
Last updated: June 19, 2012
Last verified: June 2012

June 16, 2012
June 19, 2012
January 2009
December 2011   (final data collection date for primary outcome measure)
HBeAg seroconversion rate [ Time Frame: 48weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01623778 on ClinicalTrials.gov Archive Site
HBV DNA decline [ Time Frame: 48weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Optimization of Antiviral Therapy of Chronic HBV Infection
Observation Study of Different Optimized Therapy Method of Patients With Chronic Hepatitis B

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood samples were retented at 12w,24w and 48w after optimized therapy

Non-Probability Sample

cases of HBeAg-positive CHB with inadequate response to 24 weeks Peg interferon alpha-2a were enrolled.

  • Australia Antigen Positive
  • Hepatitis B
  • Adverse Effects
Drug: Interferon Alfa-2a add on ADV
Interferon add on ADV for 48 weeks
Other Names:
  • Response guild treatment
  • optimized therapy
  • Chronic HBV infection
  • Add on ADV
    Patients with inadequate response to interferon at 24 weeks received interferon add on ADV optimized therapy
    Intervention: Drug: Interferon Alfa-2a add on ADV
  • Switch to LDT
    Patients with inadequate response to interferon at 24 weeks received switching to LDT therapy
    Intervention: Drug: Interferon Alfa-2a add on ADV
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
December 2011
December 2011   (final data collection date for primary outcome measure)

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).
Both
16 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01623778
HBV2012
No
LiangXS, Changhai Hospital
Changhai Hospital
Not Provided
Study Director: Wan Mo Bin, Dr Changhai Hospital affiliated to the Second Military Medical University
Changhai Hospital
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP