Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in HBeAg-positive and HBeAg-negative Chronic Hepatitis B (HBRN)

NCT01369212 Phase 3 COMPLETED Results posted

This clinical trial compares the efficacy of peginterferon plus tenofovir for 24 weeks followed by monotherapy with tenofovir for a further 3.5 years to the efficacy of tenofovir alone given for 4 years in patients with chronic hepatitis B. The primary measure of outcome will be HBsAg loss in serum at 48 weeks after stopping all antiviral therapy (sustained off-treatment response).

Details

Lead sponsor	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phase	Phase 3
Status	COMPLETED
Enrolment	201
Start date	2012-11
Completion	2021-03-08

Conditions

• Hepatitis B

Interventions

• Tenofovir
• Peginterferon-alfa 2a and tenofovir

Primary outcomes

• Percent of Participants With Hepatitis B Surface Antigen (HBsAg) Loss by Week 240 — Week 240
  Estimated percent of participants who became HBsAg negative by week 240 from randomization

Countries

United States, Canada