Optimization of Antiviral Therapy of Chronic HBV Infection
| Tracking Information | |||||
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| First Received Date ICMJE | June 16, 2012 | ||||
| Last Updated Date | June 19, 2012 | ||||
| Start Date ICMJE | January 2009 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
HBeAg seroconversion rate [ Time Frame: 48weeks ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01623778 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
HBV DNA decline [ Time Frame: 48weeks ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Optimization of Antiviral Therapy of Chronic HBV Infection | ||||
| Official Title ICMJE | Observation Study of Different Optimized Therapy Method of Patients With Chronic Hepatitis B | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Blood samples were retented at 12w,24w and 48w after optimized therapy |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | cases of HBeAg-positive CHB with inadequate response to 24 weeks Peg interferon alpha-2a were enrolled. |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Interferon Alfa-2a add on ADV
Interferon add on ADV for 48 weeks
Other Names:
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 67 | ||||
| Completion Date | December 2011 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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:
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| Gender | Both | ||||
| Ages | 16 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01623778 | ||||
| Other Study ID Numbers ICMJE | HBV2012 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | LiangXS, Changhai Hospital | ||||
| Study Sponsor ICMJE | Changhai Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Changhai Hospital | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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