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

This study has been withdrawn prior to enrollment.
(Sponsor withdraw)
Sponsor:
Collaborator:
Novartis
Information provided by:
University of Ulm
ClinicalTrials.gov Identifier:
NCT00710216
First received: July 2, 2008
Last updated: April 16, 2009
Last verified: April 2009
  Purpose

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 Intervention Phase
Hepatitis B, Chronic
Drug: Lamivudine
Drug: Telbivudine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: 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 NLM:


Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • Decrease in viral load after 2 weeks of therapy measured in serum HBV-DNA concentration (Copies/ml or IU/ml). [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Course of the viral load (serum HBV-DNA) during the first 12 weeks of therapy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Influence of HBeAg status to the decrease in viral load [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Influence of HBV genotype to the decrease in viral load [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in ALT and AST levels from Baseline to Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Development of viral resistance and treatment failure during the study and subsequent course of observation [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Safety assessed by adverse events and laboratory values [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00710216

Locations
Germany
University Hospital Ulm
Ulm, Germany, 89081
Sponsors and Collaborators
University of Ulm
Novartis
Investigators
Principal Investigator: Nektarios Dikopoulos, MD University Hospital Ulm
  More Information

Additional Information:
No publications provided

Responsible Party: PD Dr. med. Nektarios Dikopoulos, Universitätsklinikum Ulm
ClinicalTrials.gov Identifier: NCT00710216     History of Changes
Other Study ID Numbers: EVD-001
Study First Received: July 2, 2008
Last Updated: April 16, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Ulm:
Viral kinetics
Viral dynamics
Telbivudine
Lamivudine

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Lamivudine
Telbivudine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014