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The Optimizing Treatment of PegIFN Alfa in HBeAg-negative CHB Patients With Low Level HBsAg

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Third Affiliated Hospital, Sun Yat-Sen University
Sponsor:
Collaborators:
Peking University
Shenzhen Third People's Hospital
First People's Hospital of Foshan
Information provided by (Responsible Party):
Zhiliang Gao, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT02838810
First received: July 16, 2016
Last updated: August 27, 2016
Last verified: August 2016
  Purpose
As HBsAg clearance is uncommon in chronic hepatitis B (CHB) patients on nucleoside analogues (NAs) therapy. The purpose of this study is to optimize HBsAg clearance in CHB Patients with sequential treatment of pegylated interferon alpha and NAs.

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Optimizing Treatment of PegIFN Alfa in HBeAg-negative Chronic Hepatitis B Patients With Low Level HBsAg

Resource links provided by NLM:


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

Primary Outcome Measures:
  • HBsAg Clearance [ Time Frame: 120 weeks ] [ Designated as safety issue: No ]
    Percentage of Participants with HBsAg <0.05 IU/mL.

  • HBsAg Seroconversion [ Time Frame: 120 weeks ] [ Designated as safety issue: No ]
    Percentage of Participants with HBsAg <0.05 IU/mL and anti-HBsAg positive.


Estimated Enrollment: 200
Study Start Date: June 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental
CHB patients with low level HBsAg.Hepatitis B e antigen (HBeAg)-negative CHB patients who had received NAs for more than 12 months, with HBsAg <1000 IU/mL and Hepatitis B virus DNA <100 IU/mL, are to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week. The longest course of treatment is 96 weeks. After treatment, patients will be followed up for 24 weeks. During the 96 weeks course of treatment, HBsAg level will be monitored. When HBsAg level is less than 0.05 IU/mL, peginterferon treatment will be stopped and patients will receive 24 weeks follow up.
Drug: peginterferon alfa
peginterferon alfa-2b or peginterferon alfa-2a
Control
Patients do not need to change their NAs treatment.
Drug: Nucleoside analogues
Nucleoside analogues
Other Name: NAs

Detailed Description:
In order to optimize HBsAg clearance in CHB patients with low level HBsAg, the investigators enrolled patients who had received, and responded to, NAs for more than 12 months(see the inclusion criteria), and patients are switched to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week. The longest course of treatment is 96 weeks. After treatment, patients will be followed up for 24 weeks. During the 96 weeks course of treatment, HBsAg level will be monitored. When HBsAg level is less than 0.05 IU/mL, peginterferon treatment will be stopped and patients will receive 24 weeks follow up.
  Eligibility

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

Inclusion Criteria:

  1. CHB patients who had received single NAs for more than 12 months.
  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 AFP >2 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 or have NAs drug resistance.
  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: NCT02838810

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

Locations
China, Guangdong
The third affiliated hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Xiang Zhu, Doctor    13826452564    0628zhuxiang@163.com   
Sponsors and Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
Peking University
Shenzhen Third People's Hospital
First People's Hospital of Foshan
Investigators
Principal Investigator: Zhiliang Gao, Doctor Third Affiliated Hospital, Sun Yat-Sen University
  More Information

Responsible Party: Zhiliang Gao, Chief director of department of infectious disease, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02838810     History of Changes
Other Study ID Numbers: I-Cure-2 
Study First Received: July 16, 2016
Last Updated: August 27, 2016
Health Authority: China: Ethics Committee
Individual Participant Data  
Plan to Share IPD: Undecided

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

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
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 23, 2016