A Study to Evaluate Addition of Peginterferon Alfa-2a to Chronic Hepatitis B (CHB) Patients Treated With NAs
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|ClinicalTrials.gov Identifier: NCT02894918|
Recruitment Status : Unknown
Verified September 2016 by Jiashang, Henan Provincial People's Hospital.
Recruitment status was: Active, not recruiting
First Posted : September 9, 2016
Last Update Posted : September 12, 2016
This study evaluates whether addition of Peginterferon alfa-2a to CHB Patients Treated with nucleoside analogues (NAs) can enhance the rate of HBsAg clearance at end of treatment. This study is a Randomized, open-label, multi-center study.
The CHB patients with NAs treatment and have achieved HBV DNA <15 IU/ml、HBeAg <100 PEIU/ml、HBsAg positive and HBsAg<1500 IU/ml will be randomized into 2 groups:
Group 1 (Combination group): Maintain NAs treatment while add 48-week standard treatment by Peginterferon alfa 2a 180µg/week Group 2 (Mono NA group) : Maintain NAs treatment for 49 weeks. Note: NAs including: LAM, ADV, ETV, or TDF.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis B||Drug: Peginterferon alfa-2a||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||114 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open-label, Multi-center Clinical Trial to Evaluate Addition of Peginterferon Alfa-2a to CHB Patients Treated With NAs and Achieved HBV DNA<15 IU/ml、HBeAg<100 PEIU/ml、HBsAg Positive and HBsAg<1500 IU/ml.|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Combination group
Maintain NAs treatment while add 48-week standard treatment by Peginterferon alfa 2a 180µg/week
Drug: Peginterferon alfa-2a
180ug/0.5ml,hypodermic injection once a week
Other Name: Pegasys
No Intervention: Mono NA group
Maintain NAs mono-therapy oral-daily for 48 weeks.
- The rate of HBsAg loss [ Time Frame: 48 weeks ]To determine the response rate will be evaluated by HBsAg loss defined as HBsAg level lower than 0.05 IU/ml after 48 week treatment, compared with control group.
- Decline of HBeAg quantification [ Time Frame: 12 weeks, 24 weeks, 48 weeks of treatment ]Quantitative HBeAg reduction at Weeks 12, 24 and 48 compared with baseline level. Quantitative HBeAg value unit was calculated using 'Paul Ehrlich Institute units per millilitre' (PEIU/ml).
- Decline of HBsAg quantification [ Time Frame: 12 weeks, 24 weeks, 48 weeks of treatment ]Quantitative HBsAg reduction at Weeks 12, 24 and 48 compared with baseline level. Quantitative HBsAg calculated using 'International Units Per Millilitre' (IU/mL).
- The rate of HBeAg loss [ Time Frame: 48 weeks ]
- The rate of HBeAg seroconversion [ Time Frame: 48 weeks ]
- The rate of HBsAg seroconversion [ Time Frame: 48 weeks ]
- Sustained virological response rate [ Time Frame: 12 weeks, 24 weeks, 48 weeks of treatment ]Sustained virological response rate will be presented as rate of HBV DNA <15 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): NCT02894918
|Kaifeng Central Hospitl|
|Kaifeng, Henan, China|
|Weishi County People's Hospital|
|Kaifeng, Henan, China|
|Luoyang Central Hospital|
|Luoyang, Henan, China|
|Shangqiu No.1 People's Hospital|
|Shangqiu, Henan, China|
|Henan People's Hospital|
|Zhengzhou, Henan, China|
|Principal Investigator:||Jia Shang, M.D.||Henan People's hospital|