Efficacy and Safety of Peginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B

Chronic Hepatitis B Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01760122
• Other study ID #: TB1211IFN
• Status: Completed
• Phase: Phase 3
• First received: December 30, 2012
• Last updated: August 28, 2015
• Start date: March 2013
• Est. completion date: August 2015

Study information

• Verified date: March 2015
• Source: Xiamen Amoytop Biotech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 820
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Ypeginterferon alfa-2b
sc, qw, 48 weeks.
• Pegasys
sc, qw, 48 weeks.

Locations

Country	Name	City	State
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	Beijing University Shenzhen Hospital	Shenzhen	Guangdong
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	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan
China	First Affiliated Hospital of Xinjiang Medical University	Wulumuqi
China	Tangdu Hospital, Fourth Military Medical University	Xi'an
China	Xijing Hospital	Xi'an
China	The First Affiliated Hospital of Xiamen University	Xiamen
China	Xiamen Hospital of T.C.M	Xiamen	Fujian
China	Henan Provincial People's Hospital	Zhengzhou

Sponsors (2)

Lead Sponsor	Collaborator
Xiamen Amoytop Biotech Co., Ltd.	Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with HBeAg seroconversion at week72		24 weeks after the cessation of treatment	No
Secondary	Proportion of Patients with HBeAg seroconversion at week 12,24,48		week 12, 24, 48 from treatment starting	No
Secondary	Proportion fo patients with HBeAg undetectable at week 12, 24, 48, and 72.		week 4, 12, 24, 48 and 72 from treatment starting	No
Secondary	Average of HBV DNA decline level at week 12, 24,48 and 72		week 12, 24, 48 and 72 from treatment starting	No
Secondary	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	No
Secondary	Proportion of patients with ALT normalization at week 12,24, 48 and 72.		week 12, 24, 48 and 72 from treatment starting	No