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

Sponsor:	University of Ulm
Collaborator:	Novartis
Information provided by:	University of Ulm
ClinicalTrials.gov Identifier:	NCT00710216

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 IV

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:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

Drug Information available for: Lamivudine Telbivudine

U.S. FDA Resources

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

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:

University Hospital Ulm This link exits the ClinicalTrials.gov site

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, Chronic
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
Lamivudine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on February 09, 2012