NCT00412750

Efficacy and Safety of Telbivudine in Treatment naïve Patients With Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB)

A Randomized, Open-label, Controlled, Multi-center Two-year Study Comparing Efficacy and Safety of Telbivudine, 600 mg PO in Combination With Peginterferon Alpha-2a sq 180 µg With Peginterferon Alpha-2a Monotherapy, and With Telbivudine Monotherapy in Treatment naïve Patients With HBeAg-positive CHB.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the combination of telbivudine 600 mg orally (PO) once daily and peginterferon alpha-2a 180 ug subcutaneous (sq) injection weekly for antiviral efficacy in comparison to peginterferon alpha-2a monotherapy.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
DRUG	Telbivudine (LdT)	600 mg orally once daily for 104 weeks.
DRUG	peginterferon alpha-2a	180 μg subcutaneous injection once a week for 52 weeks.

Timeline

• Start date: 2006-12-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2006-12-18
• Last updated: 2011-07-13
• Results posted: 2011-07-13

Locations

1 site across 1 country: United States