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Peg-interferon for Inactive Chronic Hepatitis B Carriers

NCT02992704 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-07-14

No results posted yet for this study

Summary

Chronic Hepatitis B carriers (normal LFTs and viral load \< 2 x 10\^4 IU/ml are not recommended to be treated by guidelines as they are at low risk for complications. However, it is unclear if treatment can enhance HBsAg loss which has been shown to be associated with significantly lower risk of complications compared to those without HBsAg loss. Consequently, this is a proof of concept study to determine the possibility of HBsAg loss in Chronic Hepatitis B carriers in a randomised open label clinical trial comparing no treatment to 24 weeks peg-interferon alpha 2a or 48 weeks peginterferon alpha 2a (randomised 1:1:1). The primary endpoint of HBsAg loss will be evaluated 24 weeks after the end of therapy for those on therapy and matched to an equivalent timepoint in the control arm. The sample size calculation is 30 patients in each arm for a 20% difference between any experimental arm and the control arm.

Conditions

  • Chronic Hepatitis, B Virus
  • Carrier of Viral Hepatitis Type B

Interventions

DRUG

Peginterferon Alfa-2A

peginterferon alpha 2a 180mcg weekly for either 24 or 48 weeks

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Seng Gee Lim

    lead OTHER

Principal Investigators

  • Seng Gee Lim, MBBS, FRACP, FRCP, MD · National University Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2020-01-31
Completion
2020-01-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02992704 on ClinicalTrials.gov