Overview

This trial is active, not recruiting.

Condition chronic hepatitis b (hbeag-negative)
Treatment pegylated interferon alfa-2a
Sponsor José Antonio Carrion
Collaborator Instituto de Salud Carlos III
Start date January 2015
End date December 2017
Trial size 116 participants
Trial identifier NCT02743182, QUANTI-B

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Arm
(Active Comparator)
adding Pegylated interferon alfa-2a (180 microgs /week during 48 weeks) in HBeAg-negative patients receiving nucleos(t)ide analogues
pegylated interferon alfa-2a
(No Intervention)
HBeAg-negative patients receiving nucleos(t)ide analogues

Primary Outcomes

Measure
Number of patients with HBsAg loss
time frame: 1 year after treatment completion

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title HBsAg Loss Adding Pegylated Interferon Alfa-2a in HBeAg-negative Patients Treated With Nucleos(t)Ide Analogues.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Parc de Salut Mar.