HBsAg Loss Adding Pegylated Interferon in HBeAg-negative Patients

NCT ID: NCT02743182

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2018-11-30

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.

Conditions

Chronic Hepatitis B (HBeAg-negative)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Pegylated interferon alfa-2a

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

Group Type: ACTIVE_COMPARATOR

Pegylated interferon alfa-2a

Intervention Type: DRUG

Control

HBeAg-negative patients receiving nucleos(t)ide analogues

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pegylated interferon alfa-2a

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

José Antonio Carrion

OTHER

Sponsor Role: lead

Responsible Party

José Antonio Carrion

Dr.

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

QUANTI-B

Identifier Type: -

Identifier Source: org_study_id