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Trial record 116 of 351 for:    hepatitis b | Open Studies

HBsAg Loss/Seroconversion in Low Replicative Chronic Hepatitis B Virus(HBV) Infection Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Third Affiliated Hospital, Sun Yat-Sen University
Sponsor:
Collaborators:
Peking University
Huazhong University of Science and Technology
Nanchang University
Huizhou Municipal Central Hospital
First People's Hospital, Shunde China
Shenzhen Third People's Hospital
First People's Hospital of Foshan
Tang-Du Hospital
The First Affiliated Hospital of Kunming Medical College
Yuebei People's Hospital
Information provided by (Responsible Party):
Zhiliang Gao, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT02908763
First received: August 27, 2016
Last updated: September 18, 2016
Last verified: September 2016
  Purpose
HBsAg Loss/Seroconversion is uncommon in Low replicative chronic HBV infection patients. The purpose of this study is to investigate the ability of peginterferon alpha to achieve HBsAg loss/seroconversion therapy in Low replicative chronic HBV infection patients with Low Level HBsAg.

Condition Intervention Phase
Chronic Hepatitis B
Drug: peginterferon alfa
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: HBsAg Loss/Seroconversion in Low Replicative Chronic HBV Infection Patients With Low Level HBsAg Treated With Peginterferon Alpha

Resource links provided by NLM:


Further study details as provided by Third Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • HBsAg Clearance Rate [ Time Frame: 96 weeks ]
    Percentage of Participants with HBsAg negative.


Secondary Outcome Measures:
  • HBsAg Seroconversion Rate [ Time Frame: 96 weeks ]
    Percentage of Participants with HBsAg negative and anti-HBsAg positive


Estimated Enrollment: 200
Study Start Date: August 2016
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pegylated interferon group
Low replicative chronic HBV infection patients with HBsAg <1000 IU/ mL and HBV DNA<2000 IU/mL are to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for at most 96 weeks.
Drug: peginterferon alfa
peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week, for at most 96 weeks.
Other Name: peginterferon alfa-2a or peginterferon alfa-2b
No Intervention: Observing Group
Only observing and following up in this group.

Detailed Description:

Low replicative chronic HBV infection patients with low Level HBsAg were enrolled in the out-patient department of 3rd Affiliated Hospital of Sun Yat-sen University. All of them were HBsAg positive and anti-HBs negative for more than 6 months with HBV DNA<2000 IU/mL and HBsAg levels ≤1000 IU/mL. All patients did not have other liver diseases and contraindications for interferon therapy.

After giving informed consent, patients were treated with weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week. The use of other immune suppressive or regulatory drugs and other antiviral drugs was prohibited during the course of the study.

In this study, treatment endpoint was HBsAg loss(<0.05 IU/mL) and anti-HBs positive(>10 milli-International unit(mIU)/mL) defined as seroconversion. Depending on the decline of HBsAg level, treatment was either continued for a prolonged period (no more than 96 weeks) until the endpoint was achieved, or terminated in case of nonresponse. Treatment was proceeded if HBsAg level continued to decline until HBsAg seroconversion was achieved and the anti-HBs level was above 200 mIU/ml. If the patients were not willing to extend treatment, the therapy was ended at the time of HBsAg loss, or stopped without further decline of HBsAg levels.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Hepatitis B surface antigen (HBsAg) positive and <1000 IU/mL.
  2. Hepatitis B surface antibody (HBsAb) negative.
  3. Hepatitis B e antigen (HBeAg) negative.
  4. Hepatitis B virus DNA <2000 IU/mL.
  5. Absence of previous antiviral therapy.

Exclusion Criteria:

  1. Patients with active alcohol and/or drugs consumption.
  2. Patients with liver cirrhosis, Hepatocellular Carcinoma or other malignancies.
  3. Patients with other factors causing liver diseases.
  4. Pregnant and lactating women.
  5. Patients with concomitant HIV infection or congenital immune deficiency diseases.
  6. Patients with diabetes, autoimmune diseases.
  7. Patients with important organ dysfunctions.
  8. Patients with mental illness.
  9. Patients who receive antineoplastic or immunomodulatory therapy in the past 12 months.
  10. Patients who can't come back to clinic for follow-up on schedule.
  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: NCT02908763

Locations
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
Peking University
Huazhong University of Science and Technology
Nanchang University
Huizhou Municipal Central Hospital
First People's Hospital, Shunde China
Shenzhen Third People's Hospital
First People's Hospital of Foshan
Tang-Du Hospital
The First Affiliated Hospital of Kunming Medical College
Yuebei People's Hospital
  More Information

Responsible Party: Zhiliang Gao, chief director of department of infectious disease, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02908763     History of Changes
Other Study ID Numbers: 3rd-SYSU-I-Cure-4
Study First Received: August 27, 2016
Last Updated: September 18, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Third Affiliated Hospital, Sun Yat-Sen University:
Chronic Hepatitis B
Peginterferon Alpha

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

ClinicalTrials.gov processed this record on March 29, 2017