Efficacy and Safety of Peginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B
A Phase 3, Randomized, Multi-center, Active-controlled, Open-label Study to Evaluate the Efficacy and Safety of Peginterferon Alfa-2b (40kD, Y Shape) in Chinese Chronic Hepatitis B Patients.
1 other identifier
interventional
820
1 country
43
Brief Summary
This study is aimed to assess the efficacy and safety of Peginterferon alfa-2b (40kD, Y-shape), in a dose of 180μg/week, in chronic hepatitis B patients, and collects sufficient evidences for the listed of the studied drug.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2013
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 30, 2012
CompletedFirst Posted
Study publicly available on registry
January 3, 2013
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedAugust 31, 2015
March 1, 2015
2.3 years
December 30, 2012
August 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients with HBeAg seroconversion at week72
24 weeks after the cessation of treatment
Secondary Outcomes (5)
Proportion of Patients with HBeAg seroconversion at week 12,24,48
week 12, 24, 48 from treatment starting
Proportion fo patients with HBeAg undetectable at week 12, 24, 48, and 72.
week 4, 12, 24, 48 and 72 from treatment starting
Average of HBV DNA decline level at week 12, 24,48 and 72
week 12, 24, 48 and 72 from treatment starting
Average of HBsAg decline level at week 12, 24, 48 and 72, and Proportion of patients with HBsAg undetectable and HBsAg seroconversion at week 12, 24, 48 and 72.
week 12, 24, 48 and 72 from treatment starting
Proportion of patients with ALT normalization at week 12,24, 48 and 72.
week 12, 24, 48 and 72 from treatment starting
Study Arms (2)
Ypeginterferon Alfa-2b
EXPERIMENTALPegasys
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Age: 18\~65 years.
- Serum HBsAg or HBV DNA positive for at least 6 months.
- Serum HBsAg and HBeAg are both positive, HBV DNA ≥ 20,000IU/ml at screening.
- ×ULN≤ ALT ≤10×ULN at screening (ULN=upper limit of normal).
- Pregnancy tests of female patients must be negative. All patients with effective birth control measures during treatment period and 6 months after the treatment.
You may not qualify if:
- Pregnant or lactating women.
- Mental disorder or physical disability.
- Interferon treatment history or using nucleos(t)ide analogue for chronic hepatitis B treatment within the previous 6 months.
- ANC \< 1500/mm3, or PLT \< 90,000/mm3.
- Co-infection with HAV, HIV, HCV, HDV, or HEV.
- Both of HBsAg and anti-HBs are positive, or both of HBeAg and anti-HBe are positive at screening.
- Child-Pugh ≥ B, or other evidence of hepatitis decompensation (e.g.: prothrombin time prolonged more than 3 seconds, TBil \> 2ULN, Alb\<35g/L).
- Chronic hepatitis caused by any other reason except hepatitis B.
- Hepatocarcinoma or suffering from any other malignant tumor.
- Not well-controlled endocrine diseases (e.g.: thyroid dysfunction, diabetes mellitus)
- Significant function damage in any major organs (e.g.: heart, lung, kidney).
- Other Conditions which in the opinion of the investigator precluding enrollment into the study (e.g.: poor compliance).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xiamen Amoytop Biotech Co., Ltd.lead
- Peking University First Hospitalcollaborator
Study Sites (43)
Xiamen Hospital of T.C.M
Xiamen, Fujian, 361000, China
Beijing University Shenzhen Hospital
Shenzhen, Guangdong, 518036, China
302 Military Hospital
Beijing, China
Beijing Ditan Hospital Capital Medical University
Beijing, China
Beijing Youan Hospital, Capital Medical University
Beijing, China
Beijing Youyi Hospital, Capital Medical University
Beijing, China
Peking University First Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
First Affiliated Hospital of Jilin University
Changchun, China
Xiangya Hospital, Central-south University
Changsha, China
Xiangya Second Hospital, Central-south University
Changsha, China
West China Hospital, Sichuan University
Chengdu, China
Second Affiliated Hospital Chongqing Medical University
Chongqing, China
Southwest Hospital
Chongqing, China
Fuzhou Infectious Disease Hospital
Fuzhou, China
Guangzhou Eighth People's Hospital
Guangzhou, China
Nanfang Hospital
Guangzhou, China
First Affiliated Hospital of Guangxi Medical University
Guilin, China
First Affiliated Hospital, Zhejiang University
Hangzhou, China
Second Affiliated Hospital of Harbin Medical University
Harbin, China
Jinan Infectious Disease Hospital
Jinan, China
First Affiliated Hospital of Lanzhou University
Lanzhou, China
81 Military Hospital
Nanchang, China
First Affiliated Hospital of Nanchang University
Nanchang, China
Jiangsu Province Hospital
Nanjing, China
Second Hospital of Nanjing
Nanjing, China
85 Military Hospital
Shanghai, China
Huashan Hospital
Shanghai, China
Ruijing Hospital
Shanghai, China
Shanghai Public Health Clinical Center
Shanghai, China
Shengjing Hospital of China Medical University
Shenyang, China
Shenyang Sixed People's Hospital
Shenyang, China
Third Affiliated Hospital, Hebei Medical University
Shijiazhuang, China
First Affiliated Hospital, Shanxi University
Taiyuan, China
Tianjin Third Central Hospital
Tianjin, China
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, China
First Affiliated Hospital of Wenzhou Medical College
Wenzhou, China
Tongji Hospital, Huazhong University of Science & Technology
Wuhan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China
Tangdu Hospital, Fourth Military Medical University
Xi'an, China
Xijing Hospital
Xi'an, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
Henan Provincial People's Hospital
Zhengzhou, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wang Guiqiang, Ph.D
Peking University First Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2012
First Posted
January 3, 2013
Study Start
March 1, 2013
Primary Completion
July 1, 2015
Study Completion
August 1, 2015
Last Updated
August 31, 2015
Record last verified: 2015-03