Efficacy of Switching or Adding Pegylated Interferon in Chronic Hepatitis B Patients on Long Term Oral Antiviral Therapy
Status:
Completed
Trial end date:
2018-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Seng Gee Lim
Collaborators:
Changi General Hospital Merck Sharp & Dohme Corp. Singapore Clinical Research Institute Singapore General Hospital Tan Tock Seng Hospital