HBsAg Loss Adding Pegylated Interferon in HBeAg-negative Patients

Not Applicable

Completed

• Conditions: Chronic Hepatitis B (HBeAg-negative)
• Interventions: Drug: Pegylated interferon alfa-2a

• Registration Number: NCT02743182
• Lead Sponsor: José Antonio Carrion

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-04-12
• Study First Submitted QC: 2016-04-14
• Study First Posted: 2016-04-19
• Primary Completion: 2018-10
• Study Completion: 2018-11
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-04
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of patients with HBsAg loss	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)