HBsAg Loss Adding Pegylated Interferon in HBeAg-negative Patients

November 18, 2025 updated by: José Antonio Carrion

HBsAg Loss Adding Pegylated Interferon Alfa-2a in HBeAg-negative Patients Treated With Nucleos(t)Ide Analogues.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pegylated interferon alfa-2a
adding Pegylated interferon alfa-2a (180 microgs /week during 48 weeks) in HBeAg-negative patients receiving nucleos(t)ide analogues
Drug: Pegylated interferon alfa-2a
No Intervention: Control
HBeAg-negative patients receiving nucleos(t)ide analogues

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with HBsAg loss
Time Frame: 1 year after treatment completion
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)
1 year after treatment completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

José Antonio Carrion

Collaborators

Instituto de Salud Carlos III

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

April 12, 2016

First Submitted That Met QC Criteria

April 14, 2016

First Posted (Estimated)

April 19, 2016

Study Record Updates

Last Update Posted (Estimated)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QUANTI-B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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