- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02589652
Switch or Sequential Combination Therapy of Peginterferon in Hepatitis B Patients With Longterm Entecavir Therapy
Efficacy of Switch or Sequential Combination Therapy of Pegylated Interferon Alfa-2a in Chronic Hepatitis B Patients With Low HBsAg and HBeAg Titers After Long-term Entecavir Therapy: A Multicenter, Prospective Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Chronic hepatitis B (CHB) infection remains a global health treat. The ideal end point of therapy is HBsAg loss or HBsAg seroconversion, indicating a complete remission of CHB. In patients with HBeAg-positive CHB, sustained HBeAg seroconversion is also a desirable end point. Current therapies include pegylated interferon (PegIFN) finite and nucleos(t)ide analogues (NUCs) longterm therapy. However, only 30-40% of patients may achieve HBeAg seroconversion on PegIFN monotherapy, whereas 15-20% of patients on entecavir (ETV). Recently, accumulating evidence had shown that optimization of switching or combining PegIFN in patients on long-term ETV therapy may increase rate of HBeAg seroconversion and even lead to the complete eradication of HBV. However, these two regimens has not been tested adequately in patients with low HBsAg/HBeAg titers on long-term ETV therapy.
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Yiqi Yu, MD
- Phone Number: 8123 +86 21 52888123
- Email: 07301010205@fudan.edu.cn
Study Contact Backup
- Name: Wenhong Zhang, MD, PhD
- Phone Number: 8123 +86 21 52889999
- Email: zhangwenhong@fudan.edu.cn
Study Locations
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Anhui
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Hefei, Anhui, China
- The first affiliated hospital, anhui medical university
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Contact:
- Jiabin Li
- Email: lijiabin9441@vip.sohu.com
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Hefei, Anhui, China
- The second affiliated hospital, anhui medical university
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Contact:
- Yufeng Gao
- Email: aygyf@126.com
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Beijing
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Beijing, Beijing, China
- Beijing Ditan Hospital
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Contact:
- Yao Xie
- Email: xieyao@public.bta.net.cn
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Fujian
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Fuzhou, Fujian, China
- Fuzhou Municipal Infectious Disease Hospital
-
Contact:
- Minghua Lin
- Email: fulmh@yahoo.com.cn
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Guangdong
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Guangzhou, Guangdong, China
- Zhongshan No.2 People's Hospital, Zhongshan, Guangdong
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Shenzhen, Guangdong, China
- The Third People's Hospital of Shenzhen
-
Contact:
- Jing Yuan
- Email: 13500054798@139.com
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Hebei
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Shijiazhuang, Hebei, China
- The Third Hospital of Hebei Medical University
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Contact:
- Caiyan Zhao
- Email: zhaoy2005@163.com
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-
Jiangsu
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Suzhou, Jiangsu, China
- Fifth People's Hospital of Suzhou
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Contact:
- Chuanwu Zhu
- Email: zhuchw@126.com
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Xuzhou, Jiangsu, China
- The Affiliated Hospital of Xuzhou Medical College
-
Contact:
- Xuebing Yan
- Email: yxbxuzhou@126.com
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Liaoning
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Shenyang, Liaoning, China
- Shenyang Municipal Infectious Disease Hospital
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Contact:
- Mingxiang Zhang
- Email: zmx6511@126.com
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Shandong
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Jinan, Shandong, China
- Shandong Provincial Hospital of Shandong University
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Contact:
- Wanhua Ren
- Email: ganbingzx@163.com
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-
Shanxi
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Xi'an, Shanxi, China
- The First Affiliated Hospital Medical School of Xi'an Jiaotong University
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Contact:
- Yingren Zhao
- Email: zhaoyingren@sohu.com
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Sichuan
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Luzhou, Sichuan, China, 646000
- The Affiliated Hospital of Luzhou Medical College
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Contact:
- Gang Wu
- Phone Number: 0830-2292040
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Sichuan, Sichuan, China
- Sichuan Provincial People's Hospital
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Contact:
- Xingxiang Yang
- Email: xxyang508@tom.com
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Zhejiang
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Hangzhou, Zhejiang, China
- The First Affiliated Hospital, College of Medicine, Zhejiang University
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Contact:
- Xiaowei Xu
- Email: xxw69@126.com
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Ningbo, Zhejiang, China, 315040
- The Second Hospital of Yinzhou of Ningbo
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Contact:
- Guojun Li
- Email: 13615880689@163.com
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Rui'an, Zhejiang, China
- Rui'an People's Hospital
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Contact:
- Liang Hong
- Phone Number: 0577-65866555
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male and female patients > 18 and ≤ 60 years of age;
- 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:
- Evidence of decompensated cirrhosis or hepatocellular carcinoma;
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Switch group
Patients who have been assigned to 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
Other Names:
|
Sequential combination group (S-C group)
Patients who have been assigned to pegylated interferon alfa-2a plus entecavir.
|
ETV 0.5mg oral daily plus PegIFN alfa-2a 180ug subcutaneous injection weekly for 48 weeks
Other Names:
|
ETV group
Patients who have been assigned to entecavir monotherapy.
|
ETV 0.5mg oral daily for 48 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of HBeAg seroconversion
Time Frame: week 72 (24 weeks after 48 weeks of treatment)
|
Loss of HBeAg and detection of anti-HBe antibodies
|
week 72 (24 weeks after 48 weeks of treatment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of HBsAg loss
Time Frame: week 72 (24 weeks after 48 weeks of treatment)
|
HBsAg loss with or without detection of anti-HBs antibodies
|
week 72 (24 weeks after 48 weeks of treatment)
|
Rate of HBV DNA <20IU/mL
Time Frame: week 72 (24 weeks after 48 weeks of treatment)
|
week 72 (24 weeks after 48 weeks of treatment)
|
|
Rate of HBsAg seroconversion
Time Frame: week 72 (24 weeks after 48 weeks of treatment)
|
week 72 (24 weeks after 48 weeks of treatment)
|
|
Percentage of patients reaching a ≥ 1log10 decline of quantitative HBsAg
Time Frame: week 72 (24 weeks after 48 weeks of treatment)
|
week 72 (24 weeks after 48 weeks of treatment)
|
|
Decline of quantitative HBsAg from baseline
Time Frame: week 72 (24 weeks after 48 weeks of treatment
|
week 72 (24 weeks after 48 weeks of treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wenhong Zhang, MD, PhD, Huashan Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
- Hepatitis, Chronic
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Immunologic Factors
- Interferons
- Interferon-alpha
- Peginterferon alfa-2a
- Interferon alpha-2
- Entecavir
Other Study ID Numbers
- 81271833
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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