Clinical trial NCT03181113: Long-term Benefit in Chronic Hepatitis B Patients After Standard Peginterferon Alfa Therapy
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B
Keywords: peginterferon alpha
HBeAg seroconversion
immune control
Lead sponsor: Xiamen Amoytop Biotech Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Peking University First Hospital
First posted: 2017-06-08
Enrollment: 473
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic hepatitis B who previously participated in TB1211IFN study.

Brief 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.


Eligibility criteria: 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).

Primary outcomes:
measure: rate of HBeAg seroconversion
timeFrame: from the second year to the fifth year
Secondary outcomes:
measure: decent degree of HBeAg
timeFrame: from the second year to the fifth year
measure: decent degree of HBV DNA
timeFrame: from the second year to the fifth year
measure: rate of alanine aminotransferase normalization
timeFrame: from the second year to the fifth year
measure: rate of HBeAg loss
timeFrame: from the second year to the fifth year
measure: rate of HBV DNA undetectable
timeFrame: from the second year to the fifth year
measure: rate of HBeAg seroconversion
timeFrame: from the second year to the fifth year
Other outcomes:
Locations:
city: Beijing
country: China
facility: 302 Military Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Ditan Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Youan Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Chongqing
country: China
facility: Second Affiliated Hospital Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: Southwest Hospital
state: Chongqing
city: Fuzhou
country: China
facility: Fuzhou Infectious Disease Hospital
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Xiamen
country: China
facility: Xiamen Hospital of T.C.M
state: Fujian
city: Guangzhou
country: China
facility: Guangzhou Eighth People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Beijing University Shenzhen Hospital
state: Guangdong
city: Shijiazhuang
country: China
facility: Third Affiliated Hospital, Hebei Medical University
state: Hebei
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Changsha
country: China
facility: Xiangya Hospital, Central-south University
state: Hunan
city: Changsha
country: China
facility: Xiangya Second Hospital, Central-south University
state: Hunan
city: Nanjing
country: China
facility: 81 Military Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Second Hospital of Nanjing
state: Jiangsu
city: Nanchang
country: China
facility: First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Shenyang
country: China
facility: Shenyang Sixth People's Hospital
state: Liaoning
city: Jinan
country: China
facility: Jinan Infectious Disease Hospital
state: Shandong
city: Shanghai
country: China
facility: 85 Military Hospital
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Ruijing Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Third Central Hospital
state: Tianjin
city: Wenzhou
country: China
facility: First Affiliated Hospital of Wenzhou Medical College
state: Zhejiang
Study officials:
affiliation: Peking University First Hospital
name: Guiqiang Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: