Clinical trial NCT01143662: Efficacy and Safety of Ypeginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis B
Keywords: peginterferon
interferon
Pegasys
HBV
Hepatitis B
HBeAg positive
Lead sponsor: Xiamen Amoytop Biotech Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Peking University First Hospital
First posted: 2010-06-14
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.
* 2×ULN≤ALT≤10×ULN at screening(ULN=upper limit of normal).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Efficacy
timeFrame: week 24 from treatment start
Secondary outcomes:
measure: Efficacy
timeFrame: week 12, 24, 48 from treatment start and week 24 after treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: 302 Military Hospital
city: Beijing
country: China
facility: Beijing Youan Hospital, Capital Medical University
city: Beijing
country: China
facility: Beijing Youyi Hospital, Capital Medical University
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Changchun
country: China
facility: First Affiliated Hospital of Jilin University
city: Changsha
country: China
facility: Xiangya Hospital, Central-south University
city: Changsha
country: China
facility: Xiangya Second Hospital, Central-south University
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Chongqing
country: China
facility: Southwest Hospital
city: Fuzhou
country: China
facility: Fuzhou Infectious Disease Hospital
city: Guangzhou
country: China
facility: Guangzhou Eighth People's Hospital
city: Guangzhou
country: China
facility: Nanfang Hospital
city: Guangzhou
country: China
facility: Third Affiliated Hospital of Sun Yat-sen University
city: Guilin
country: China
facility: First Affiliated Hospital of Guangxi Medical University
city: Hangzhou
country: China
facility: First Affiliated Hospital, Zhejiang University
city: Harbin
country: China
facility: Second Affiliated Hospital of Harbin Medical University
city: Hefei
country: China
facility: First Affiliated Hospital of Anhui Medical University
city: Jinan
country: China
facility: Jinan Infectious Disease Hospital
city: Lanzhou
country: China
facility: First Affiliated Hospital of Lanzhou University
city: Nanchang
country: China
facility: First Affiliated Hospital of Nanchang University
city: Nanjing
country: China
facility: 81 Military Hospital
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Nanjing
country: China
facility: Second Hospital of Nanjing
city: Shanghai
country: China
facility: 85 Militay Hospital
city: Shanghai
country: China
facility: Changhai Hospital
city: Shanghai
country: China
facility: Huashan Hospital
city: Shanghai
country: China
facility: Renji Hospital
city: Shanghai
country: China
facility: Ruijin Hospital
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
city: Shenzhen
country: China
facility: Shenzhen Third People's Hospital
city: Shijiazhuang
country: China
facility: Third Affiliated Hospital, Hebei Medical University
city: Taiyuan
country: China
facility: First Affiliated Hospital, Shanxi University
city: Tianjin
country: China
facility: Tianjin Third Central Hospital
city: Wenzhou
country: China
facility: First Affiliated Hospital of Wenzhou Medical College
city: Wuhan
country: China
facility: Tongji Hospital, Huazhong University of Science&Technology
city: Xian
country: China
facility: Tangdu Hospital, Fourth Military Medical University
city: Zhengzhou
country: China
facility: First Affiliated Hospital of Zhengzhou University
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
Study officials:
affiliation: Peking University First Hospital
name: Wang Guiqiang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: