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

NCT ID: NCT03181113

Last Updated: 2021-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

473 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-18

Study Completion Date

2020-09-21

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis B

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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peginterferon alfa 2b

Peginterferon Alfa-2B

Intervention Type DRUG

pre-received standard peginterferon alfa-2b therapy

peginterferon alfa 2a

Peginterferon Alfa-2A

Intervention Type DRUG

pre-received standard peginterferon alfa-2a therapy

Interventions

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Peginterferon Alfa-2B

pre-received standard peginterferon alfa-2b therapy

Intervention Type DRUG

Peginterferon Alfa-2A

pre-received standard peginterferon alfa-2a therapy

Intervention Type DRUG

Other Intervention Names

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pegberon pegasys

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University First Hospital

OTHER

Sponsor Role collaborator

Xiamen Amoytop Biotech Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guiqiang Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

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302 Military Hospital

Beijing, Beijing Municipality, China

Site Status

Beijing Ditan Hospital Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Beijing Youan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status

Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status

Second Affiliated Hospital Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status

Southwest Hospital

Chongqing, Chongqing Municipality, China

Site Status

Fuzhou Infectious Disease Hospital

Fuzhou, Fujian, China

Site Status

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Site Status

Xiamen Hospital of T.C.M

Xiamen, Fujian, China

Site Status

Guangzhou Eighth People's Hospital

Guangzhou, Guangdong, China

Site Status

Nanfang Hospital

Guangzhou, Guangdong, China

Site Status

Beijing University Shenzhen Hospital

Shenzhen, Guangdong, China

Site Status

Third Affiliated Hospital, Hebei Medical University

Shijiazhuang, Hebei, China

Site Status

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Site Status

Xiangya Hospital, Central-south University

Changsha, Hunan, China

Site Status

Xiangya Second Hospital, Central-south University

Changsha, Hunan, China

Site Status

81 Military Hospital

Nanjing, Jiangsu, China

Site Status

Second Hospital of Nanjing

Nanjing, Jiangsu, China

Site Status

First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status

Shenyang Sixth People's Hospital

Shenyang, Liaoning, China

Site Status

Jinan Infectious Disease Hospital

Jinan, Shandong, China

Site Status

85 Military Hospital

Shanghai, Shanghai Municipality, China

Site Status

Huashan Hospital

Shanghai, Shanghai Municipality, China

Site Status

Ruijing Hospital

Shanghai, Shanghai Municipality, China

Site Status

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Site Status

Tianjin Third Central Hospital

Tianjin, Tianjin Municipality, China

Site Status

First Affiliated Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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TB1510IFN

Identifier Type: -

Identifier Source: org_study_id

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