Trial | NCT02743182  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    119
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 Started
Jan 31
2015
Primary Completion
Oct 31
2018
Study Completion
Nov 30
2018
Last Update
Sep 06
2019

Drug Pegylated interferon alfa-2a

Pegylated interferon alfa-2a Active Comparator

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

Control No Intervention

HBeAg-negative patients receiving nucleos(t)ide analogues

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
No Results Posted