MedTrace Logo

Efficacy of Switching or Adding Pegylated Interferon in Chronic Hepatitis B Patients on Long Term Oral Antiviral Therapy

NCT01928511 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2019-09-24

No results posted yet for this study

Summary

Patients with Chronic Hepatitis B on long term oral antiviral therapy have to continue treatment indefinitely unless they achieve HBeAg seroconversion or HBsAg seroclearance, when therapy can be stopped. While HBeAg seroconversion is a more achievable endpoint, only 20-25% of patients develop this after one year of oral antiviral therapy. HBsAg seroclearance is universally infrequent. Strategies to improve these endpoints such as combination oral antiviral therapy have not been generally successful and recently studies have examined the possibility of switching or adding peginterferon therapy. However these have not been tested adequately in the group of patients that have been on long term oral antiviral therapy. Consequently this study was conceived to evaluate whether switching or adding peginterferon compared to continuing oral antiviral therapy are more efficacious strategies. HBeAg positive and HBeAg negative patients (n=310)will be randomised to continue oral antiviral therapy, switch or add pegylated interferon for 48 weeks in a ratio of 1:2:2 respectively. The study endpoints are HBsAg seroclearance, reduction of qHBsAg \>1 log, qHBsAg\<200 IU/ml, HBeAg loss and seroconversion, and HBV DNA suppression, all at week 72.

Conditions

Interventions

DRUG

peg-interferon alpha 2b, 1.5mcg/kg s/c given weekly

DRUG

Nucleos(t)ide analogue therapy

Sponsors & Collaborators

  • Tan Tock Seng Hospital

    collaborator OTHER

  • Singapore Clinical Research Institute

    collaborator OTHER

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Singapore General Hospital

    collaborator OTHER

  • Changi General Hospital

    collaborator OTHER

  • 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
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT01928511 on ClinicalTrials.gov