NCT01928511 — drugset

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.

Timeline

Start: 2014-01
Primary completion: 2018-12
Completion: 2018-12

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Adefovir	Unknown	10 mg	Oral
Subject	Entecavir	Small molecule	0.5 mg	Oral
Subject	Entecavir	Small molecule	1 mg	Oral
Subject	Lamivudine	Other / unclassified	100 mg	Oral
Subject	Peginterferon alfa-2b	Protein / enzyme biologic	1.5 ug/kg	—
Subject	Tenofovir	Small molecule	300 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications