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

April 16, 2009 updated by: University of Ulm

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)

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Ulm, Germany, 89081
        • University Hospital Ulm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Drug: Lamivudine
100 mg/day
Other Names:
  • LAM
  • Epivir
  • Zeffix
  • J05AF05
  • 134678-17-4
  • 73339
Experimental: B
Drug: Telbivudine
600 mg/day
Other Names:
  • Sebivo
  • Tyzeka
  • L-dT
  • 3424-98-4
  • J05AF11
  • 159269

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulm

Collaborators

Novartis

Investigators

  • Principal Investigator: Nektarios Dikopoulos, MD, University Hospital Ulm

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

July 2, 2008

First Submitted That Met QC Criteria

July 2, 2008

First Posted (Estimate)

July 4, 2008

Study Record Updates

Last Update Posted (Estimate)

April 20, 2009

Last Update Submitted That Met QC Criteria

April 16, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVD-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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