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

Primary Purpose

Hepatitis B, Chronic

Status
Withdrawn
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Lamivudine
Telbivudine
Sponsored by
University of Ulm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic focused on measuring Viral kinetics, Viral dynamics, Telbivudine, Lamivudine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Ulm

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Course of the viral load (serum HBV-DNA) during the first 12 weeks of therapy
Influence 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

Full Information

First Posted
July 2, 2008
Last Updated
April 16, 2009
Sponsor
University of Ulm
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00710216
Brief Title
Comparison of Telbivudine Versus Lamivudine on the Early Dynamics and Kinetics of Viral Suppression in Chronic Hepatitis B
Acronym
EVD
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

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor withdraw
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Ulm
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic
Keywords
Viral kinetics, Viral dynamics, Telbivudine, Lamivudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Other Intervention Name(s)
Zeffix, Epivir, LAM, 134678-17-4, J05AF05, 73339
Intervention Description
100 mg/day
Intervention Type
Drug
Intervention Name(s)
Telbivudine
Other Intervention Name(s)
Sebivo, Tyzeka, L-dT, 3424-98-4, J05AF11, 159269
Intervention Description
600 mg/day
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Course of the viral load (serum HBV-DNA) during the first 12 weeks of therapy
Time Frame
12 weeks
Title
Influence of HBeAg status to the decrease in viral load
Time Frame
12 weeks
Title
Influence of HBV genotype to the decrease in viral load
Time Frame
12 weeks
Title
Change in ALT and AST levels from Baseline to Week 12
Time Frame
12 weeks
Title
Development of viral resistance and treatment failure during the study and subsequent course of observation
Time Frame
6 month
Title
Safety assessed by adverse events and laboratory values
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nektarios Dikopoulos, MD
Organizational Affiliation
University Hospital Ulm
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.uniklinik-ulm.de/
Description
University Hospital Ulm

Learn more about this trial

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

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