Switch or Sequential Combination Therapy of Peginterferon in Hepatitis B Patients With Longterm Entecavir Therapy
NCT ID: NCT02589652
Last Updated: 2015-10-28
Study Results
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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UNKNOWN
294 participants
OBSERVATIONAL
2015-10-31
2017-10-31
Brief Summary
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Detailed Description
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This is a multicenter, prospective cohort study to evaluate the efficacy and safety of sequential combination or switch therapy of pegylated interferon alfa-2a in chronic hepatitis B patients with low HBsAg and HBeAg titers after long-term entecavir therapy, and compared to those who continued on ETV therapy.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Switch group
Patients who have been assigned to pegylated interferon alfa-2a.
Pegylated interferon alfa-2a
ETV 0.5mg oral daily plus PegIFN alfa-2a 180ug subcutaneous injection weekly for 8 weeks and followed by PegIFN alfa-2a 180ug subcutaneous injection weekly for 40 weeks
Sequential combination group (S-C group)
Patients who have been assigned to pegylated interferon alfa-2a plus entecavir.
Pegylated interferon alfa-2a plus Entecavir
ETV 0.5mg oral daily plus PegIFN alfa-2a 180ug subcutaneous injection weekly for 48 weeks
ETV group
Patients who have been assigned to entecavir monotherapy.
Entecavir
ETV 0.5mg oral daily for 48 weeks
Interventions
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Pegylated interferon alfa-2a
ETV 0.5mg oral daily plus PegIFN alfa-2a 180ug subcutaneous injection weekly for 8 weeks and followed by PegIFN alfa-2a 180ug subcutaneous injection weekly for 40 weeks
Pegylated interferon alfa-2a plus Entecavir
ETV 0.5mg oral daily plus PegIFN alfa-2a 180ug subcutaneous injection weekly for 48 weeks
Entecavir
ETV 0.5mg oral daily for 48 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Positive HBsAg for more than 6 months;
* Patients receiving previous ETV therapy ≥2 years;
* Patients who have achieved undetectable HBV DNA, HBsAg \<1500IU/mL and HBeAg \<200S/CO prior to switch or S-C therapy;
* ALT\<=10\*ULN and TB\<2\*ULN;
* Patients who have been assigned to treatment with PegIFN (S-C or switch) or continuous ETV after previous ETV therapy
Exclusion Criteria
* Serological evidence of co-infection with HCV, HDV or HIV;
* Pregnant or breast-feeding women;
* Patients with diseases that might contraindicate to PegIFN therapy including severe psychiatric diseases, immunological diseases, severe retinopathy, thyroid dysfunction, leukocytopenia, thrombopenia, etc
* Patients receiving concomitant therapy with telbivudine;
* A history of drug or alcohol abuse;
* Other conditions that investigates consider not suitable for participate
18 Years
60 Years
ALL
No
Sponsors
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Huashan Hospital
OTHER
Responsible Party
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Wen-hong Zhang
Director of Division of Infectious Diseases
Principal Investigators
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Wenhong Zhang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Huashan Hospital
Locations
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The First Affiliated Hospital, Anhui Medical University
Hefei, Anhui, China
The Second Affiliated Hospital, Anhui Medical University
Hefei, Anhui, China
Beijing Ditan Hospital
Beijing, Beijing Municipality, China
Fuzhou Municipal Infectious Disease Hospital
Fuzhou, Fujian, China
Zhongshan No.2 People's Hospital, Zhongshan, Guangdong
Guangzhou, Guangdong, China
The third People's Hospital of Shenzhen
Shenzhen, Guangdong, China
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Fifth People's Hospital of Suzhou
Suzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, China
Shenyang Municipal Infectious Disease Hospital
Shenyang, Liaoning, China
Shandong Provincial Hospital of Shandong University
Jinan, Shandong, China
The First Affiliated Hospital Medical School of Xi'an Jiaotong University
Xi’an, Shanxi, China
The Affiliated Hospital of Luzhou Medical College
Luzhou, Sichuan, China
Sichuan Provincial People's Hospital
Sichuan, Sichuan, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
The Second Hospital of Yinzhou of Ningbo
Ningbo, Zhejiang, China
Rui'an People's Hospital
Rui’an, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Gang Wu
Role: primary
Liang Hong
Role: primary
Other Identifiers
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81271833
Identifier Type: -
Identifier Source: org_study_id
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