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

Chronic Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01143662
• Other study ID #: TB1007IFN
• Status: Completed
• Phase: Phase 2
• First received: June 11, 2010
• Last updated: January 31, 2013
• Start date: July 2010
• Est. completion date: April 2012

Study information

• Verified date: June 2010
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: April 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

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, for 48 weeks.
• Peginterferon alfa-2a
sc, qw, for 48 weeks.

Locations

Country	Name	City	State
China	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	Xian
China	First Affiliated Hospital of Zhengzhou University	Zhengzhou
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	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	Yes
Secondary	Efficacy	Average of HBV DNA decline level at week 12, 48 and 72.; Proportion of patients with HBV DNA undetectable at week 48 and 72.; Proportion of patients with HBeAg undetectable and HBeAg seroconversion at week 48 and 72.; Proportion of patients with HBsAg undetectable and HBsAg seroconversion at week 48 and 72.; Proportion of patients with ALT normalization at week 24 and 48.	week 12, 24, 48 from treatment start and week 24 after treatment	Yes