Prospective Exploratory Study to Describe Hepatitis B Virus (HBV) Kinetics During Treatment With Telbivudine

Phase 3

Completed

• Conditions: Hepatitis B, Chronic
• Interventions: Drug: Telbivudine; Drug: oral adefovir

• Registration Number: NCT00640588
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study will explore HBV kinetics in CHB patients during the first 24 weeks of treatment with telbivudine

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-17
• Study First Submitted QC: 2008-03-20
• Study First Posted: 2008-03-21
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-24
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Male or female, at least 18 years of age.
• Documented compensated HBeAg negative CHB defined by baseline HBV serology, DNA and ALT criteria.

Exclusion Criteria

• Co-infection with HCV, HDV, or HIV.
• Prior therapy with nucleos(t)ides in NAÏVE patient and prior treatment with lamivudine in patients with suboptimal response to adefovir.
• History of hepatic decompensation
• History of malignancy
• Patient has one or more additional known primary or secondary causes of liver disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Telbivudine	Telbivudine
2	oral adefovir	Arm 2: 600 mg/day, oral telbivudina plus 10 mg/day oral adefovir for 24 weeks

Primary Outcome Measures

Name	Time	Method
HBV viral load will be measured by HBV DNA quantification in plasma (log opies/mL) at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks	at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks

Secondary Outcome Measures

Name	Time	Method
Liver function assessed at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks HBV genotype measured at baseline	at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks

Trial Locations

Locations (1)

Novartis Investigative Site; 🇪🇸 Barcelona, Spain