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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00710216
Recruitment Status : Withdrawn (Sponsor withdraw)
First Posted : July 4, 2008
Last Update Posted : April 20, 2009
Information provided by:
University of Ulm

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.

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: Lamivudine Drug: Telbivudine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: A Drug: Lamivudine
100 mg/day
Other Names:
  • Zeffix
  • Epivir
  • LAM
  • 134678-17-4
  • J05AF05
  • 73339

Experimental: B Drug: Telbivudine
600 mg/day
Other Names:
  • Sebivo
  • Tyzeka
  • L-dT
  • 3424-98-4
  • J05AF11
  • 159269

Primary Outcome Measures :
  1. Decrease in viral load after 2 weeks of therapy measured in serum HBV-DNA concentration (Copies/ml or IU/ml). [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Course of the viral load (serum HBV-DNA) during the first 12 weeks of therapy [ Time Frame: 12 weeks ]
  2. Influence of HBeAg status to the decrease in viral load [ Time Frame: 12 weeks ]
  3. Influence of HBV genotype to the decrease in viral load [ Time Frame: 12 weeks ]
  4. Change in ALT and AST levels from Baseline to Week 12 [ Time Frame: 12 weeks ]
  5. Development of viral resistance and treatment failure during the study and subsequent course of observation [ Time Frame: 6 month ]
  6. Safety assessed by adverse events and laboratory values [ Time Frame: 6 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00710216

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University Hospital Ulm
Ulm, Germany, 89081
Sponsors and Collaborators
University of Ulm
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Principal Investigator: Nektarios Dikopoulos, MD University Hospital Ulm
Additional Information:
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Responsible Party: PD Dr. med. Nektarios Dikopoulos, Universitätsklinikum Ulm Identifier: NCT00710216    
Other Study ID Numbers: EVD-001
First Posted: July 4, 2008    Key Record Dates
Last Update Posted: April 20, 2009
Last Verified: April 2009
Keywords provided by University of Ulm:
Viral kinetics
Viral dynamics
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents