Efficacies of Entecavir Add on HBeAg Negative Patients With HBV DNA Positive During Peginterferon Alpha 2a Treatment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02365402|
Recruitment Status : Unknown
Verified August 2016 by Yao Xie, Beijing Ditan Hospital.
Recruitment status was: Recruiting
First Posted : February 18, 2015
Last Update Posted : August 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis B||Drug: Entecavir||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacies of Entecavir Add on HBeAg Negative Chronic Hepatitis B Patients With HBV DNA Load ≥1000 Copies/ml After 3 Months of Peginterferon Alpha 2a Treatment|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
Experimental: entecavir with PEG-IFN a-2a
After enrolled, entecavir will added, and patients will receive treatment of PEG-IFN a-2a combine with entecavir for 48 weeks and 24 weeks of follow up after treatment.
After enrolled, entecavir will added, and patients will receive treatment of PEG-IFN a-2a combine with entecavir for 48 weeks and 24 weeks of follow-up after treatment.
No Intervention: control group
In this group, patients will be continue treated only by PEG-IFN a-2a for 48 weeks after enrolled and receive 24 weeks of follow up.
- rate of sustained virual response [ Time Frame: 72 weeks ]sustained viral response was defined as serum HBV DNA load was undetectable at the end of treatment and 24 weeks of follow-up.
- rates of HBsAg loss during treatment course and at the end of follow-up [ Time Frame: 72 weeks ]HBsAg loss defined as HBsAg level ≤0.05 IU/ml
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): NCT02365402
|Contact: yao Xieemail@example.com|
|Beijing Ditan hospital,Capital Medical University||Recruiting|
|Beijing, Beijing, China, 100015|
|Contact: Yao Xie, doctor 8613501093293 firstname.lastname@example.org|
|Principal Investigator: Yao Xie, doctor|