Efficacy of Peginterferon Alpha 2a Therapy in Chronic Hepatitis B Patients Being Treated With Nucleoside(Acid) Analogues
|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: NCT02362490|
Recruitment Status : Unknown
Verified August 2016 by Yao Xie, Beijing Ditan Hospital.
Recruitment status was: Recruiting
First Posted : February 13, 2015
Last Update Posted : September 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis B||Drug: peginterferon alpha 2a||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||HBsAg Clearance of Peginterferon Treatment in Patients Who Had Chronic Hepatitis B and Were on the Treatment of Nucleoside(Acid) Analogues|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
Experimental: peginterferon alpha 2a
in this group, patients who were on treatment of Nucleoside (Acid) Analogues and had achieved HBsAg level ≤250 IU/ml will switch to treatment of peginterferon alpha 2a for 72 week.
Drug: peginterferon alpha 2a
in this group,patients will receive 180 ug of peginterferon alpha 2a injection weekly for 72 weeks
Other Name: PEG-IFN a-2a
No Intervention: control group
in this group, patients who were on treatment of Nucleoside(Acid) Analogues and had achieved HBsAg level ≤250 IU/ml will be continue to treatment of Nucleoside(Acid) Analogues for 72 week.
- rate of HBsAg loss [ Time Frame: 72 weeks ]the effects of peginterferon alpha 2a will be evaluated by HBsAg loss defined as HBsAg level lower than 0.05 IU/ml after 72 week treatment,compared control group.
- decline of HBsAg level [ Time Frame: 72 weeks ]secondary outcome was evaluated by the decline of HBsAg level after 72 weeks of peginterferon alpha 2a treatment compared with control group.
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): NCT02362490
|Contact: Yao Xie, MDemail@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|