NCT00710216

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 4, 2008

Completed
Last Updated

April 20, 2009

Status Verified

April 1, 2009

First QC Date

July 2, 2008

Last Update Submit

April 16, 2009

Conditions

Hepatitis B, Chronic

Keywords

Viral kineticsViral dynamicsTelbivudineLamivudine

Outcome Measures

Primary Outcomes (1)

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

    2 weeks

Secondary Outcomes (6)

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

    12 weeks

  • Influence of HBeAg status to the decrease in viral load

    12 weeks

  • Influence of HBV genotype to the decrease in viral load

    12 weeks

  • Change in ALT and AST levels from Baseline to Week 12

    12 weeks

  • Development of viral resistance and treatment failure during the study and subsequent course of observation

    6 month

  • +1 more secondary outcomes

Study Arms (2)

A

ACTIVE COMPARATOR
Drug: Lamivudine

B

EXPERIMENTAL
Drug: Telbivudine

Interventions

LamivudineDRUG

100 mg/day

Also known as: Zeffix, Epivir, LAM, 134678-17-4, J05AF05, 73339
A
TelbivudineDRUG

600 mg/day

Also known as: Sebivo, Tyzeka, L-dT, 3424-98-4, J05AF11, 159269
B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ulm

Ulm, 89081, Germany

Location

Related Links

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

LamivudinelipoarabinomannanTelbivudine

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosidesThymidine

Study Officials

  • Nektarios Dikopoulos, MD

    University Hospital Ulm

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 2, 2008

First Posted

July 4, 2008

Last Updated

April 20, 2009

Record last verified: 2009-04

Locations

DE(1)