Clinical trial NCT01760122: Efficacy and Safety of Peginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis B
Keywords: peginterferon
HBeAg Positive
Chronic hepatitis B
Lead sponsor: Xiamen Amoytop Biotech Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Peking University First Hospital
First posted: 2013-01-03
Enrollment: 820
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.
* 2×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.

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.
* 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).

Primary outcomes:
measure: Proportion of patients with HBeAg seroconversion at week72
timeFrame: 24 weeks after the cessation of treatment
Secondary outcomes:
measure: Proportion of Patients with HBeAg seroconversion at week 12,24,48
timeFrame: week 12, 24, 48 from treatment starting
measure: Proportion fo patients with HBeAg undetectable at week 12, 24, 48, and 72.
timeFrame: week 4, 12, 24, 48 and 72 from treatment starting
measure: Average of HBV DNA decline level at week 12, 24,48 and 72
timeFrame: week 12, 24, 48 and 72 from treatment starting
measure: 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.
timeFrame: week 12, 24, 48 and 72 from treatment starting
measure: Proportion of patients with ALT normalization at week 12,24, 48 and 72.
timeFrame: week 12, 24, 48 and 72 from treatment starting
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Xiamen Hospital of T.C.M
state: Fujian
city: Shenzhen
country: China
facility: Beijing University Shenzhen Hospital
state: Guangdong
city: Beijing
country: China
facility: 302 Military Hospital
city: Beijing
country: China
facility: Beijing Ditan Hospital Capital Medical University
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: Second Affiliated Hospital Chongqing Medical 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: 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: Jinan
country: China
facility: Jinan Infectious Disease Hospital
city: Lanzhou
country: China
facility: First Affiliated Hospital of Lanzhou University
city: Nanchang
country: China
facility: 81 Military Hospital
city: Nanchang
country: China
facility: First Affiliated Hospital of Nanchang University
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Nanjing
country: China
facility: Second Hospital of Nanjing
city: Shanghai
country: China
facility: 85 Military Hospital
city: Shanghai
country: China
facility: Huashan Hospital
city: Shanghai
country: China
facility: Ruijing Hospital
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
city: Shenyang
country: China
facility: Shenyang Sixed 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: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
city: Wulumuqi
country: China
facility: First Affiliated Hospital of Xinjiang Medical University
city: Xi'an
country: China
facility: Tangdu Hospital, Fourth Military Medical University
city: Xi'an
country: China
facility: Xijing Hospital
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
Study officials:
affiliation: Peking University First Hospital
name: Wang Guiqiang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: