Optimization of Antiviral Therapy of Chronic HBV Infection

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01623778
• Other study ID #: HBV2012
• Status: Completed
• Phase: N/A
• First received: June 16, 2012
• Last updated: June 19, 2012
• Start date: January 2009
• Est. completion date: December 2011

Study information

• Verified date: June 2012
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

Inclusion Criteria:

patients receiving Peg interferon a-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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adverse Effects
• Australia Antigen Positive
• Hepatitis
• Hepatitis B

Intervention

Drug:
• Interferon Alfa-2a add on ADV
Interferon add on ADV for 48 weeks

Locations

Country	Name	City	State
China	Changhai hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBeAg seroconversion rate		48weeks	Yes
Secondary	HBV DNA decline		48weeks	Yes