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Completed

NCT Number: NCT02743182

HBsAg Loss Adding Pegylated Interferon in HBeAg-negative Patients

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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Key information

Conditions

Chronic Hepatitis B (HBeAg-negative) Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pegylated interferon alfa-2a

Drug

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

José Antonio Carrion

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 19, 2016
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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