Long-term Benefit in Chronic Hepatitis B Patients After Standard Peginterferon Alfa Therapy

Hepatitis B Clinical Trial

Official title:

A Multi-center, Prospective Study to Acess Long-term Benefit in HBeAg Positive Chronic Hepatitis B Patients Who Previously Received Standard Peginterferon Alfa Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03181113
• Other study ID #: TB1510IFN
• Status: Completed
• Start date: May 18, 2016
• Est. completion date: September 21, 2020

Study information

• Verified date: April 2021
• Source: Xiamen Amoytop Biotech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this cohort study, patients with chronic hepatitis B who prior participated in TB1211IFN study and received at least 39 doses of peginterferon alfa will be enrolled. HBsAg/anti-HBs level, HBeAg/anti-HBe level, Serum HBV DNA load and alanine transaminase level will be test every year from the second year to the fifth year after the ending of peginterferon alfa treatment, and long-term benefit of interferon treatment will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 473
• Est. completion date: September 21, 2020
• Est. primary completion date: September 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Understand and sign the informed consent form.
• Participated in NCT01760122 study (TB1211IFN) and has received at least 39 doses of peginterferon.

Exclusion Criteria:

• Conditions which in the opinion of the investigator should be precluded from the study(e.g., poor compliance).

Related Conditions & MeSH terms

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

Intervention

Drug:
• Peginterferon Alfa-2B
pre-received standard peginterferon alfa-2b therapy
• Peginterferon Alfa-2A
pre-received standard peginterferon alfa-2a therapy

Locations

Country	Name	City	State
China	302 Military Hospital	Beijing	Beijing
China	Beijing Ditan Hospital Capital Medical University	Beijing	Beijing
China	Beijing Youan Hospital, Capital Medical University	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	Xiangya Hospital, Central-south University	Changsha	Hunan
China	Xiangya Second Hospital, Central-south University	Changsha	Hunan
China	Second Affiliated Hospital Chongqing Medical University	Chongqing	Chongqing
China	Southwest Hospital	Chongqing	Chongqing
China	Fuzhou Infectious Disease Hospital	Fuzhou	Fujian
China	Guangzhou Eighth People's Hospital	Guangzhou	Guangdong
China	Nanfang Hospital	Guangzhou	Guangdong
China	Jinan Infectious Disease Hospital	Jinan	Shandong
China	First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	81 Military Hospital	Nanjing	Jiangsu
China	Second Hospital of Nanjing	Nanjing	Jiangsu
China	85 Military Hospital	Shanghai	Shanghai
China	Huashan Hospital	Shanghai	Shanghai
China	Ruijing Hospital	Shanghai	Shanghai
China	Shanghai Public Health Clinical Center	Shanghai	Shanghai
China	Shenyang Sixth People's Hospital	Shenyang	Liaoning
China	Beijing University Shenzhen Hospital	Shenzhen	Guangdong
China	Third Affiliated Hospital, Hebei Medical University	Shijiazhuang	Hebei
China	Tianjin Third Central Hospital	Tianjin	Tianjin
China	First Affiliated Hospital of Wenzhou Medical College	Wenzhou	Zhejiang
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	Xiamen Hospital of T.C.M	Xiamen	Fujian
China	Henan Provincial People's Hospital	Zhengzhou	Henan

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	rate of HBeAg seroconversion		from the second year to the fifth year
Secondary	decent degree of HBeAg		from the second year to the fifth year
Secondary	decent degree of HBV DNA		from the second year to the fifth year
Secondary	rate of alanine aminotransferase normalization		from the second year to the fifth year
Secondary	rate of HBeAg loss		from the second year to the fifth year
Secondary	rate of HBV DNA undetectable		from the second year to the fifth year
Secondary	rate of HBeAg seroconversion		from the second year to the fifth year