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HBsAg Loss Adding Pegylated Interferon in HBeAg-negative Patients

Primary Purpose

Chronic Hepatitis B (HBeAg-negative)

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pegylated interferon alfa-2a
Sponsored by
José Antonio Carrion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Hepatitis B (HBeAg-negative)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic hepatitis B (HBeAg-negative)
  • Signed inform consent
  • Aged > 18

Exclusion Criteria:

  • Contraindications for Pegylated interferon (cirrhosis, pregnancy, others)
  • Previous treatment with interferon or Pegylated interferon
  • Previous HBsAg loss
  • Treatment duration with Nucleos(t)ide analogues less than 2 years
  • Poor adherence to Nucleos(t)ide analogues

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Pegylated interferon alfa-2a

    Control

    Arm Description

    adding Pegylated interferon alfa-2a (180 microgs /week during 48 weeks) in HBeAg-negative patients receiving nucleos(t)ide analogues

    HBeAg-negative patients receiving nucleos(t)ide analogues

    Outcomes

    Primary Outcome Measures

    Number of patients with HBsAg loss
    HBsAg will be evaluated one year after treatment completion (96 weeks). Efficacy will be calculated as a proportion (rate of patients with HBsAg loss/treated patients)

    Secondary Outcome Measures

    Full Information

    First Posted
    April 12, 2016
    Last Updated
    September 4, 2019
    Sponsor
    José Antonio Carrion
    Collaborators
    Instituto de Salud Carlos III
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02743182
    Brief Title
    HBsAg Loss Adding Pegylated Interferon in HBeAg-negative Patients
    Official Title
    HBsAg Loss Adding Pegylated Interferon Alfa-2a in HBeAg-negative Patients Treated With Nucleos(t)Ide Analogues.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    October 2018 (Actual)
    Study Completion Date
    November 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    José Antonio Carrion
    Collaborators
    Instituto de Salud Carlos III

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Chronic hepatitis B (CHB) affects more than 350 million people worldwide. The most common form in Europe is CHB HBeAg-negative. Antiviral treatment of CHB HBeAg-negative patients includes chronic administration of nucleos(t)ide analogues (NUC) or pegylated interferon (PegIFN) during 12 months. Typically, PegIFN allows immune control of CHB and antigen "s" (HBsAg) loss in around 4% of patients compared to less than 0,1% using NUC. Recently, it has been described that HBsAg quantification (HBsAg-q) is useful to identify patients with high probability to lose HBsAg during follow-up. In addition, a proof-of-concept study with nine HBeAg-negative patients receiving NUC showed that adding PegIFN (16 weeks) achieved HBsAg loss in one patient (11%). The aim of our study is to evaluate the efficacy and safety adding PegIFN (48 weeks) in treated HBeAg-negative patients with NUC.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Hepatitis B (HBeAg-negative)

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    119 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pegylated interferon alfa-2a
    Arm Type
    Active Comparator
    Arm Description
    adding Pegylated interferon alfa-2a (180 microgs /week during 48 weeks) in HBeAg-negative patients receiving nucleos(t)ide analogues
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    HBeAg-negative patients receiving nucleos(t)ide analogues
    Intervention Type
    Drug
    Intervention Name(s)
    Pegylated interferon alfa-2a
    Primary Outcome Measure Information:
    Title
    Number of patients with HBsAg loss
    Description
    HBsAg will be evaluated one year after treatment completion (96 weeks). Efficacy will be calculated as a proportion (rate of patients with HBsAg loss/treated patients)
    Time Frame
    1 year after treatment completion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Chronic hepatitis B (HBeAg-negative) Signed inform consent Aged > 18 Exclusion Criteria: Contraindications for Pegylated interferon (cirrhosis, pregnancy, others) Previous treatment with interferon or Pegylated interferon Previous HBsAg loss Treatment duration with Nucleos(t)ide analogues less than 2 years Poor adherence to Nucleos(t)ide analogues

    12. IPD Sharing Statement

    Learn more about this trial

    HBsAg Loss Adding Pegylated Interferon in HBeAg-negative Patients

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