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Trial record 4 of 1866 for:    "Hepatitis, Chronic"

The Optimizing Treatment of Peginterferon (PEG IFN) Alpha in Chronic Hepatitis B Virus Patients With Low Level HBsAg

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ClinicalTrials.gov Identifier: NCT02893124
Recruitment Status : Recruiting
First Posted : September 8, 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:
HBeAg-negative chronic hepatitis B (CHB) patients with low Level HBsAg and with a history of drug resistance or suboptimal/partial virological response were enrolled. After giving informed consent, patients were treated with nucleoside analog(s) (NAs) once a day and weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 12 weeks. 12 weeks later, NAs was stopped, patients were treated with weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week. Treatment endpoint was HBsAg loss(<0.05 IU/mL).

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

Detailed Description:

It is estimated that more than 400 million people are infected with hepatitis B virus (HBV) globally. HBeAg-negative CHB patients with low Level HBsAg and with a history of drug resistance or suboptimal/partial virological response 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<100 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 NAs once a day and weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 12 weeks. 12 weeks later, NAs was stopped, 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).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.


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: The Optimizing Treatment of Peginterferon Alpha in HBeAg-negative Chronic Hepatitis B Virus Patients With Low Level HBsAg
Actual Study Start Date : August 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PEG-IFN group
HBeAg-negative CHB patients with HBsAg <1000 IU/ mL and HBV DNA<100 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: NAs group
CHB patients do not need to change their NAs treatment.



Primary Outcome Measures :
  1. HBsAg Clearance [ Time Frame: 96 weeks ]
    Percentage of Participants with HBsAg <0.05 IU/mL.


Secondary Outcome Measures :
  1. HBsAg Seroconversion [ Time Frame: 96 weeks ]
    Percentage of Participants with HBsAg <0.05 IU/mL 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. CHB patients who had received single NAs for more than 12 months and had a history of NAs drug resistance or suboptimal/partial virological response.
  2. Hepatitis B e antigen (HBeAg)-negative.
  3. Hepatitis B surface antigen (HBsAg) positive and <1000 IU/mL.
  4. Hepatitis B virus DNA <100 IU/mL.

Exclusion Criteria:

  1. Patients with liver cirrhosis, Hepatocellular Carcinoma or alpha feto protein (AFP) >2 upper limit of normal(ULN) or other malignancies.
  2. Patients with other factors causing liver diseases.
  3. Pregnant and lactating women.
  4. Patients with concomitant HIV infection or congenital immune deficiency diseases.
  5. Patients with diabetes, autoimmune diseases.
  6. Patients with important organ dysfunctions.
  7. Patients with serious complications (e.g., infection, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding.)
  8. Patients who receive antineoplastic or immunomodulatory therapy in the past 12 months.
  9. Patients with a previous use of IFN anti hepatitis B virus treatment.
  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): NCT02893124


Contacts
Contact: Xiang Zhu 13826452564 0628zhuxiang@163.com

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

Responsible Party: Zhiliang Gao, Chief director of department of infectious disease, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02893124     History of Changes
Other Study ID Numbers: I-Cure-3
First Posted: September 8, 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

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