Efficacy and Safety of Ypeginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B
A Multi-center, Randomized, Open-label and Positive Controlled Phase II Clinical Trial to Assess Efficacy and Safety of Ypeginterferon Alfa-2b in HBeAg Positive Patients With Chronic Hepatitis B
1 other identifier
interventional
205
1 country
39
Brief Summary
This study is a multi-center, randomized, open-label and positive controlled Phase II Clinical trial to assess efficacy and safety of Ypeginterferon alfa-2b, once a week, in 3 dose-groups: 90mcg, 135mcg and 180mcg, respectively, for treatment of chronic hepatitis B characterized by HBeAg positivity, with Pegasys 180mcg/week as positive control. It is aimed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of Phase III trials, and generate pharmacokinetic data of Ypeginterferon alfa-2b in hepatitis B patients to satisfy regulatory requirements.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2010
39 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
June 11, 2010
CompletedFirst Posted
Study publicly available on registry
June 14, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedFebruary 4, 2013
June 1, 2010
9 months
June 11, 2010
January 31, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy
* Average of HBV DAN decline level at week 24. * Proportion of patients with HBeAg undetectable and HBeAg seroconversion at week 24.
week 24 from treatment start
Secondary Outcomes (1)
Efficacy
week 12, 24, 48 from treatment start and week 24 after treatment
Study Arms (4)
Group 1
EXPERIMENTALYpeginterferon alfa-2b 90mcg per week
Group 2
EXPERIMENTALYpeginterferon alfa-2b 135mcg per week
Group 3
EXPERIMENTALYpeginterferon alfa-2b 180mcg per week
Group 4
ACTIVE COMPARATORPegasys 180mcg per week
Interventions
Eligibility Criteria
You may qualify if:
- Age:18\~60 years.
- Pregnancy tests of female patients must be negative. All patients with effective birth control measures during treatment period and 6 months after the cessation of treatment.
- Serum HBsAg positive for at least 6 months.
- Serum HBeAg positive with HBV DNA ≥20,000IU/ml.
- ×ULN≤ALT≤10×ULN at screening(ULN=upper limit of normal).
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.
- WBC\<3000/mm3, or ANC \<1500/mm3, or PLT \<90,000/mm3.
- Co-infection with HAV, HIV, HCV, HDV, HEV.
- Both HBsAg and anti-HBs are positive, or both HBeAg and anti-HBe are positive at screening.
- Chest X-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease.
- Evidence of hepatic decompensation.
- History of hypothyroidism or current treatment for thyroid disease.
- Uncontrolled significant chronic medical conditions other than chronic hepatitis B, or other conditions which in the opinion of the investigator preclude enrollment into the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xiamen Amoytop Biotech Co., Ltd.lead
- Peking University First Hospitalcollaborator
Study Sites (39)
302 Military Hospital
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
Southwest Hospital
Chongqing, China
Fuzhou Infectious Disease Hospital
Fuzhou, China
Guangzhou Eighth People's Hospital
Guangzhou, China
Nanfang Hospital
Guangzhou, China
Third Affiliated Hospital of Sun Yat-sen University
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
First Affiliated Hospital of Anhui Medical University
Hefei, China
Jinan Infectious Disease Hospital
Jinan, China
First Affiliated Hospital of Lanzhou University
Lanzhou, China
First Affiliated Hospital of Nanchang University
Nanchang, China
81 Military Hospital
Nanjing, China
Jiangsu Province Hospital
Nanjing, China
Second Hospital of Nanjing
Nanjing, China
85 Militay Hospital
Shanghai, China
Changhai Hospital
Shanghai, China
Huashan Hospital
Shanghai, China
Renji Hospital
Shanghai, China
Ruijin Hospital
Shanghai, China
Shanghai Public Health Clinical Center
Shanghai, China
Shenzhen Third People's Hospital
Shenzhen, 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 Wenzhou Medical College
Wenzhou, China
Tongji Hospital, Huazhong University of Science&Technology
Wuhan, China
Tangdu Hospital, Fourth Military Medical University
Xi'an, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Henan Provincial People's Hospital
Zhengzhou, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wang Guiqiang, MD, PhD
Peking University First Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2010
First Posted
June 14, 2010
Study Start
July 1, 2010
Primary Completion
April 1, 2011
Study Completion
April 1, 2012
Last Updated
February 4, 2013
Record last verified: 2010-06