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Trial record 76 of 546 for:    "Viral Infectious Disease" | "Peginterferon alfa-2a"

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

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ClinicalTrials.gov Identifier: NCT02908763
Recruitment Status : Recruiting
First Posted : September 21, 2016
Last Update Posted : May 22, 2018
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

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: peginterferon alfa Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : August 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



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


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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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.

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): NCT02908763


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
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

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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
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Zhiliang Gao, Third Affiliated Hospital, Sun Yat-Sen University:
Chronic Hepatitis B
Peginterferon Alpha
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
DNA Virus Infections
Peginterferon alfa-2a
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Hepadnaviridae Infections
Peginterferon alfa-2b
Antiviral Agents
Anti-Infective Agents