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Trial record 139 of 517 for:    hepatitis b | Open Studies

Switch or Sequential Combination Therapy of Peginterferon in Hepatitis B Patients With Longterm Entecavir Therapy

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2015 by Huashan Hospital
Sponsor:
Information provided by (Responsible Party):
Wen-hong Zhang, Huashan Hospital
ClinicalTrials.gov Identifier:
NCT02589652
First received: October 25, 2015
Last updated: October 27, 2015
Last verified: October 2015
  Purpose
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.

Condition Intervention
Chronic Hepatitis B
Drug: Pegylated interferon alfa-2a
Drug: Pegylated interferon alfa-2a plus Entecavir
Drug: Entecavir

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Huashan Hospital:

Primary Outcome Measures:
  • Rate of HBeAg seroconversion [ Time Frame: week 72 (24 weeks after 48 weeks of treatment) ] [ Designated as safety issue: No ]
    Loss of HBeAg and detection of anti-HBe antibodies


Secondary Outcome Measures:
  • Rate of HBsAg loss [ Time Frame: week 72 (24 weeks after 48 weeks of treatment) ] [ Designated as safety issue: No ]
    HBsAg loss with or without detection of anti-HBs antibodies

  • Rate of HBV DNA <20IU/mL [ Time Frame: week 72 (24 weeks after 48 weeks of treatment) ] [ Designated as safety issue: No ]
  • Rate of HBsAg seroconversion [ Time Frame: week 72 (24 weeks after 48 weeks of treatment) ] [ Designated as safety issue: No ]
  • Percentage of patients reaching a ≥ 1log10 decline of quantitative HBsAg [ Time Frame: week 72 (24 weeks after 48 weeks of treatment) ] [ Designated as safety issue: No ]
  • Decline of quantitative HBsAg from baseline [ Time Frame: week 72 (24 weeks after 48 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 294
Study Start Date: October 2015
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Switch group
Patients who have been assigned to pegylated interferon alfa-2a.
Drug: 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 Name: PegIFN alpha-2a
Sequential combination group (S-C group)
Patients who have been assigned to pegylated interferon alfa-2a plus entecavir.
Drug: Pegylated interferon alfa-2a plus Entecavir
ETV 0.5mg oral daily plus PegIFN alfa-2a 180ug subcutaneous injection weekly for 48 weeks
Other Names:
  • PegIFN alpha-2a
  • ETV
ETV group
Patients who have been assigned to entecavir monotherapy.
Drug: Entecavir
ETV 0.5mg oral daily for 48 weeks
Other Name: ETV

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Chronic Hepatitis B Patients with Low HBsAg and HBeAg Titers after Long-term Entecavir Therapy
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02589652

Contacts
Contact: Yiqi Yu, MD +86 21 52888123 ext 8123 07301010205@fudan.edu.cn
Contact: Wenhong Zhang, MD, PhD +86 21 52889999 ext 8123 zhangwenhong@fudan.edu.cn

Locations
China, Anhui
The First Affiliated Hospital, Anhui Medical University Not yet recruiting
Hefei, Anhui, China
Contact: Jiabin Li       lijiabin9441@vip.sohu.com   
The Second Affiliated Hospital, Anhui Medical University Not yet recruiting
Hefei, Anhui, China
Contact: Yufeng Gao       aygyf@126.com   
China, Beijing
Beijing Ditan Hospital Not yet recruiting
Beijing, Beijing, China
Contact: Yao Xie       xieyao@public.bta.net.cn   
China, Fujian
Fuzhou Municipal Infectious Disease Hospital Not yet recruiting
Fuzhou, Fujian, China
Contact: Minghua Lin       fulmh@yahoo.com.cn   
China, Guangdong
Zhongshan No.2 People's Hospital, Zhongshan, Guangdong Active, not recruiting
Guangzhou, Guangdong, China
The third People's Hospital of Shenzhen Not yet recruiting
Shenzhen, Guangdong, China
Contact: Jing Yuan       13500054798@139.com   
China, Hebei
The Third Hospital of Hebei Medical University Not yet recruiting
Shijiazhuang, Hebei, China
Contact: Caiyan Zhao       zhaoy2005@163.com   
China, Jiangsu
Fifth People's Hospital of Suzhou Not yet recruiting
Suzhou, Jiangsu, China
Contact: Chuanwu Zhu       zhuchw@126.com   
The Affiliated Hospital of Xuzhou Medical College Not yet recruiting
Xuzhou, Jiangsu, China
Contact: Xuebing Yan       yxbxuzhou@126.com   
China, Liaoning
Shenyang Municipal Infectious Disease Hospital Not yet recruiting
Shenyang, Liaoning, China
Contact: Mingxiang Zhang       zmx6511@126.com   
China, Shandong
Shandong Provincial Hospital of Shandong University Not yet recruiting
Jinan, Shandong, China
Contact: Wanhua Ren       ganbingzx@163.com   
China, Shanxi
The First Affiliated Hospital Medical School of Xi'an Jiaotong University Not yet recruiting
Xi'an, Shanxi, China
Contact: Yingren Zhao       zhaoyingren@sohu.com   
China, Sichuan
The Affiliated Hospital of Luzhou Medical College Not yet recruiting
Luzhou, Sichuan, China, 646000
Contact: Gang Wu    0830-2292040      
Sichuan Provincial People's Hospital Not yet recruiting
Sichuan, Sichuan, China
Contact: Xingxiang Yang       xxyang508@tom.com   
China, Zhejiang
The First Affiliated Hospital, College of Medicine, Zhejiang University Not yet recruiting
Hangzhou, Zhejiang, China
Contact: Xiaowei Xu       xxw69@126.com   
The Second Hospital of Yinzhou of Ningbo Not yet recruiting
Ningbo, Zhejiang, China, 315040
Contact: Guojun Li       13615880689@163.com   
Rui'an People's Hospital Not yet recruiting
Rui'an, Zhejiang, China
Contact: Liang Hong    0577-65866555      
Sponsors and Collaborators
Huashan Hospital
Investigators
Principal Investigator: Wenhong Zhang, MD, PhD Huashan Hospital, Fudan University
  More Information

Responsible Party: Wen-hong Zhang, Director of Division of Infectious Diseases, Huashan Hospital
ClinicalTrials.gov Identifier: NCT02589652     History of Changes
Other Study ID Numbers: 81271833 
Study First Received: October 25, 2015
Last Updated: October 27, 2015
Health Authority: China: Ministry of Science and Technology

Keywords provided by Huashan Hospital:
Pegylated interferon
Entecavir

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Interferon-alpha
Interferons
Entecavir
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 26, 2016