Clinical trial NCT00710216: Comparison of Telbivudine Versus Lamivudine on the Early Dynamics and Kinetics of Viral Suppression in Chronic Hepatitis B
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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Keywords: Viral kinetics
Viral dynamics
Telbivudine
Lamivudine
Lead sponsor: University of Ulm
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2008-07-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Decrease in viral load after 2 weeks of therapy measured in serum HBV-DNA concentration (Copies/ml or IU/ml).
timeFrame: 2 weeks
Secondary outcomes:
measure: Course of the viral load (serum HBV-DNA) during the first 12 weeks of therapy
timeFrame: 12 weeks
measure: Influence of HBeAg status to the decrease in viral load
timeFrame: 12 weeks
measure: Influence of HBV genotype to the decrease in viral load
timeFrame: 12 weeks
measure: Change in ALT and AST levels from Baseline to Week 12
timeFrame: 12 weeks
measure: Development of viral resistance and treatment failure during the study and subsequent course of observation
timeFrame: 6 month
measure: Safety assessed by adverse events and laboratory values
timeFrame: 6 month
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: University Hospital Ulm
Study officials:
affiliation: University Hospital Ulm
name: Nektarios Dikopoulos, MD
role: PRINCIPAL_INVESTIGATOR
References: