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CompletedNCT02743182Updated Nov 24, 2025

HBsAg Loss Adding Pegylated Interferon in HBeAg-negative Patients

An interventional study of Pegylated interferon alfa-2a in Chronic Hepatitis B (HBeAg-negative), sponsored by José Antonio Carrion. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-24.

Sponsored by José Antonio Carrion · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
119
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Chronic Hepatitis B (HBeAg-negative)

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In context

Hepatitis B, Chronic

942 studies on the registry are indexed under Hepatitis B, Chronic; 145 are open to participants now.

This study's enrollment of 119 is above the median of 100 across 683 interventional studies indexed under Hepatitis B, Chronic.

Browse Hepatitis B, Chronic studies →

Lead sponsor

This is the only study on the registry with José Antonio Carrion as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
119 participants (actual)

Study arms

  • 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

Interventions

  • DrugPegylated interferon alfa-2a
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What researchers measure

Primary outcomes

  1. 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)

    Time frame: 1 year after treatment completion

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02743182
Lead sponsor
José Antonio Carrion
Collaborators
Instituto de Salud Carlos III
Responsible party
José Antonio Carrion (Dr., Parc de Salut Mar) — Sponsor-investigator
First posted
Apr 19, 2016
Start date
Jan 2015
Primary completion
Oct 2018
Completion
Nov 2018
Last update
Nov 24, 2025

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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