Efficacy and Safety of Peginterferon a-2a in Patients of Chronic Hepatitis B With Spontaneous Decline of HBV DNA
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|ClinicalTrials.gov Identifier: NCT01892241|
Recruitment Status : Completed
First Posted : July 4, 2013
Last Update Posted : October 1, 2013
|Condition or disease||Intervention/treatment||Phase|
|Antiviral Treatment of Chronic Hepatitis B||Drug: Pegasys(Roche) Drug: Entecavir||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||February 2013|
Experimental: 180µg of peginterferon alfa-2a
Cases in group A receive 180µg of peginterferon alfa-2a (Pegasys,Roche) once weekly for 48 weeks.
180µg of peginterferon alfa-2a (Pegasys,Roche) once weekly for 48 weeks.
Other Name: peginterferon alfa-2a
Active Comparator: Entecavir
cases in group B received an continual entecavir therapy(0.5 mg orally once daily)
continual entecavir therapy(0.5 mg orally once daily)
No Intervention: Control group
Those in group C didn't accept any antiviral regiment .
- Complete viralogic response [ Time Frame: week 96 ]Complete viralogic response was defined as suppression of HBV DNA to the level below 60IU/mL(detected by Cobas Amplicor HBV Monitor Test, Roche Diagnostics).
- HBsAg loss and seroconversion [ Time Frame: week 24,48,72 and 96 ]HBsAg loss was defined as HBsAg titre less than 0.05 IU/mL and the HBsAg seroconversion was defined as the loss of HBsAg and the presence of anti-HBs antibody. HBeAg seroconversion was defined as disappearance of HBeAg and appearance of anti-HBe antibody, while HBeAg loss was defined as disappearance of HBeAg only.
- ALT normalization [ Time Frame: week 24,48,72 and 96 ]ALT normalization was defined as ALT level less than 40 IU/L(determined by a sequential multiple autoanalyzer).
- Sick leave in patients in different groups [ Time Frame: week 48,72 and 96 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892241
|Study Chair:||Gao Zhiliang, doctor||The Third Affliated Hospital of Sun Yat-sen University|
|Study Director:||Zhao Zhixin, doctor||The Third Affliated Hospital of Sun Yat-sen University|