NCT00805675

Effects of Telbivudine and Tenofovir Disoproxil Fumarate Treatment on the Hepatitis B Virus DNA Kinetics in CHB

A Randomized, Open-label, Controlled, Exploratory Trial to Characterize the Results of Daily Oral Administration of Telbivudine 600 mg and Tenofovir Disproxil Fumarate 300 mg in Combination or Telbivudine 600 mg or Tenofovir Disproxil Fumarate 300 mg Monotherapy Given Over 12 Weeks on the Kinetics of Hepatitis B Virus DNA in Adults With HBeAg Positive Compensated CHB

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the safety, tolerability and effectiveness of 12 weeks of treatment with telbivudine 600 mg daily plus tenofovir DF 300 mg one daily (OD) taken together vs. tenofovir DF 300 mg once daily (QD) or vs telbivudine 600 mg monotherapy daily (QD). This is an open labeled, active controlled, viral kinetics study which means the subjects and study doctor will know what study drug subjects have been assigned. This study is open to male and female subjects, \<40 years of age, who have been infected with HBV for at least 6 months and have not received oral treatment for HBV.

Conditions

• Hepatitis B Virus

Interventions

Type	Name	Description
DRUG	Telbivudine	600 mg monotherapy supplied in film-coated tablets.
DRUG	Tenofovir	Tenofovir disoproxil fumarate was supplied in 300 mg tablets
DRUG	Telbivudine plus tenofovir	Telbivudine 600 mg and Tenofovir 300 mg were purchased in commercial packs. Patients were instructed to take medication(s) orally every morning either with or without food.

Timeline

• Start date: 2008-11-01
• Primary completion: 2010-12-01
• First posted: 2008-12-10
• Last updated: 2012-02-28
• Results posted: 2012-02-28

Locations

1 site across 1 country: China