Comparison of Telbivudine Versus Lamivudine on the Early Dynamics and Kinetics of Viral Suppression in Chronic Hepatitis B
Information source: University of Ulm
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis B, Chronic
Intervention: Lamivudine (Drug); Telbivudine (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: University of Ulm Official(s) and/or principal investigator(s):
Nektarios Dikopoulos, MD, Principal Investigator, Affiliation: University Hospital Ulm
Overall contact:
Nektarios Dikopoulos, MD, Phone: +49 (0)731-500, Ext: 44715, Email: nektarios.dikopoulos@uniklinik-ulm.de
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: Decrease in viral load after 2 weeks of therapy measured in serum HBV-DNA concentration (Copies/ml or IU/ml).
Secondary outcome: Course of the viral load (serum HBV-DNA) during the first 12 weeks of therapyInfluence of HBeAg status to the decrease in viral load Influence of HBV genotype to the decrease in viral load Change in ALT and AST levels from Baseline to Week 12 Development of viral resistance and treatment failure during the study and subsequent course of observation Safety assessed by adverse events and laboratory values
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Nektarios Dikopoulos, MD, Phone: +49 (0)731-500, Ext: 44715, Email: nektarios.dikopoulos@uniklinik-ulm.de
University Hospital Ulm, Ulm 89081, Germany
Additional Information
University Hospital Ulm
Starting date: November 2008
Ending date: May 2011
Last updated: September 29, 2008
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