Comparison of Telbivudine Versus Lamivudine on the Early Dynamics and Kinetics of Viral Suppression in Chronic Hepatitis B

Hepatitis B, Chronic Clinical Trial

— EVD  

Official title:

Randomized, Open-Label, Phase IV Trial in Nucleus(t)id-Naive Patients With Chronic Hepatitis B to Examine the Effect of Telbivudine Compared to Lamivudine on the Early Dynamics and Kinetics of Viral Suppression (Early-Viral-Dynamics Study)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00710216
• Other study ID #: EVD-001
• Status: Withdrawn
• Phase: Phase 4
• First received: July 2, 2008
• Last updated: April 16, 2009

Study information

• Verified date: April 2009
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This study examines the effect of telbivudine compared to lamivudine on the early viral kinetics in patients with chronic hepatitis B. The virus Kinetics is measured by the viral load (HBV-DNA) reduction in the serum during the first 12 weeks of therapy.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Documented compensated HBeAg-positive or negative chronic hepatitis B

• Increased viral load with a concentration of serum HBV-DNA of at least 10^4 copies/ml

• Proof of inflammatory activity in the liver: ALT = 2 x ULN or histological evidence of inflammatory activity = level I or fibrosis of = I degrees (according to the Desmet classification)

• Negative urine pregnancy test with fertile women

• Willingness to use a recognized method of contraception

• Able to comply with study regimen and provide written informed consent

Exclusion Criteria:

• Current or previous antiviral treatment of chronic hepatitis B with Nucleus(t)id analoga

• Known hypersensitivity to lamivudine or telbivudine or any of the other components of the preparations

• Pregnant or breastfeeding women or women

• Simultaneous participation in other clinical trials or in the past three months

• Co-infected with HCV, HDV, HIV

• Other non HBV-related chronic liver disease: Autoimmune hepatitis, primary biliary cirrhosis, Hemochromatosis, alpha-1 antitrypsin deficiency, alcoholic hepatitis

• Evidence of hepatocellular carcinoma (alpha-fetoprotein levels> 100 ng/ml)

• Active drug use, including an excessive alcohol consumption during the last 6 months before participating in the clinical trial

• Use of systemic treatment with anti-neoplastic or immunomodulatory medication within the last 6 months before participating in the clinical trial and during the duration of the clinical examination

• Lack of willingness or inability to consent in writing

• Concurrent condition likely to preclude compliance with schedule of evaluations

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Lamivudine
100 mg/day
• Telbivudine
600 mg/day

Locations

Country	Name	City	State
Germany	University Hospital Ulm	Ulm

Sponsors (2)

Lead Sponsor	Collaborator
University of Ulm	Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in viral load after 2 weeks of therapy measured in serum HBV-DNA concentration (Copies/ml or IU/ml).		2 weeks	No
Secondary	Course of the viral load (serum HBV-DNA) during the first 12 weeks of therapy		12 weeks	No
Secondary	Influence of HBeAg status to the decrease in viral load		12 weeks	No
Secondary	Influence of HBV genotype to the decrease in viral load		12 weeks	No
Secondary	Change in ALT and AST levels from Baseline to Week 12		12 weeks	No
Secondary	Development of viral resistance and treatment failure during the study and subsequent course of observation		6 month	No
Secondary	Safety assessed by adverse events and laboratory values		6 month	Yes

External Links

•   University Hospital Ulm