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The Clinical Cure Project of Chronic Hepatitis B in China

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04035837
Recruitment Status : Recruiting
First Posted : July 29, 2019
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Zhiliang Gao, Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary:
Chronic hepatitis B is a global public health problem, with nearly 700,000 deaths each year because of hepatitis B-related diseases. Recent studies have found that some patients who have used nucleot(s)ide analogues(NAs) for some period can achieve higher hepatitis B surface antigen(HBsAg) clearance rate(which is called clinical cure or functional cure) by using pegylated interferon. Patients who achieve clinical cure will further reduce liver inflammation, fibrosis and risks of liver cirrhosis and cancer in the future. This study was initiated in May 2018 and plans to recruit 30,000 eligible patients. The enrollment conditions are as follows: 1. according with the diagnosis of chronic hepatitis B in the guideline of China in 2015; 2.18-60 years old; 3. more than 1 year history of NAs therapy with HBsAg ≤1500 IU/ml, negative hepatitis e antigen and hepatitis B virus DNA<100 IU/ml; 4. no contraindications of interferon. For the above patients, pegylated interferon was used for 1-2 years(combined with NAs for at least 3 months).The primary goal of this study is to find out the optimal treatment for clinical cure.

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: pegylated interferon-alfa Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30000 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Peg-interferon Treatment for Nucleos(t)Ide Analogues Suppressed Chronic Hepatitis B Patients With Low Level Hepatitis Surface Antigen
Actual Study Start Date : May 16, 2018
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon

Arm Intervention/treatment
Experimental: short-course combination group
Nucleoside analogue is used during the first 3 months.
Drug: pegylated interferon-alfa
All the patients in this study will receive pegylated interferon for all course.

Experimental: full-course combination group
Nucleoside analogue is used during all the course of study.
Drug: pegylated interferon-alfa
All the patients in this study will receive pegylated interferon for all course.




Primary Outcome Measures :
  1. hepatitis B surface antigen [ Time Frame: up to 48 weeks ]
    hepatitis B surface antigen should be tested by the reagents from Roche or Abbott, which is expressed by using IU/ml.


Secondary Outcome Measures :
  1. hepatitis B surface antibody [ Time Frame: up to 48 weeks ]
    hepatitis B surface antigen should be tested by the reagents from Roche or Abbott, which is expressed by using IU/ml.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • according with the diagnosis of chronic hepatitis B in the guideline of China in 2015
  • 18-60 years old
  • more than 1 year history of nucleot(s)ide analogues therapy with HBsAg ≤1500 IU/ml, negative HBeAg and HBV DNA<100 IU/ml
  • no contraindications of interferon

Exclusion Criteria:

  • Allergy to interferon
  • Alanine transaminase >10 times of upper limit of normal(ULN) or total bilirubin >2 times of ULN
  • existing or previous decompensated liver cirrhosis
  • White blood cells or Platelet below the lower limit of normal
  • existing severe organ injury
  • combined with autoimmune diseases, psychiatric diseases, diabetes or thyroidism
  • confirmed or suspected malignant tumors
  • before or after transplantation
  • using immunosuppressor
  • pregnant or having a planned parenthood in 2 years
  • alcohol or drug addicted
  • infected by HIV
  • any conditions that is unsuitable to interferon therapy according to the doctors' judgement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04035837


Contacts
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Contact: Zhishuo Mo +86 13632434363 vbstone@126.com

Locations
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China, Guangdong
Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Zhi-Liang Gao, Professor    86-20-85252373    zhilianggao@21cn.com   
Contact: Xiang Zhu, Doctor    86-20-85252372    0628zhuxiang@163.com   
Principal Investigator: Zhi-Liang Gao, Professor         
Sponsors and Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
Investigators
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Study Chair: Zhiliang Gao Third Affiliated Hospital, Sun Yat-Sen University

Publications:

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Responsible Party: Zhiliang Gao, The director of the infectious diseases department, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT04035837    
Other Study ID Numbers: ZhuFeng Project
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study protocol would be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Interferons
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs