Prospective Exploratory Study to Describe Hepatitis B Virus (HBV) Kinetics During Treatment With Telbivudine - Full Text View

Prospective Exploratory Study to Describe Hepatitis B Virus (HBV) Kinetics During Treatment With Telbivudine (EBEREST)

This study is currently recruiting participants.

Verified by Novartis, August 2009

First Received: March 17, 2008 Last Updated: August 11, 2009 History of Changes

Sponsored by:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00640588

Purpose

This study will explore HBV kinetics in CHB patients during the first 24 weeks of treatment with telbivudine

Condition	Intervention	Phase
Hepatitis B, Chronic	Drug: Telbivudine Drug: oral adefovir	Phase III

Study Type:	Interventional
Study Design:	Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study
Official Title:	Prospective Exploratory Study to Describe in CHB naïve and Non-naïve Patients, Hepatitis B Virus (HBV) Kinetics During the First 24 Weeks of Treatment With Telbivudine

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Adefovir Adefovir dipivoxil Hepatitis B Vaccines Telbivudine

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

HBV viral load will be measured by HBV DNA quantification in plasma (log opies/mL) at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks [ Time Frame: at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Liver function assessed at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks HBV genotype measured at baseline [ Time Frame: at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	March 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Telbivudine	Drug: Telbivudine Arm 1: 600 mg/day, oral telbivudina for 24 weeks
2: Active Comparator Arm 2: 600 mg/day, oral telbivudina plus 10 mg/day oral adefovir for 24 weeks	Drug: oral adefovir Arm 2: 600 mg/day, oral telbivudina plus 10 mg/day oral adefovir for 24 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female, at least 18 years of age.
Documented compensated HBeAg negative CHB defined by baseline HBV serology, DNA and ALT criteria.

Exclusion Criteria:

Co-infection with HCV, HDV, or HIV.
Prior therapy with nucleos(t)ides in NAÏVE patient and prior treatment with lamivudine in patients with suboptimal response to adefovir.
History of hepatic decompensation
History of malignancy
Patient has one or more additional known primary or secondary causes of liver disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640588

Contacts

Contact: Novartis

41613241111

Locations

Spain
Novartis Investigative Site	Recruiting
Barcelona, Spain
Contact: Novartis 41613241111

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CLDT600AES01
Study First Received:	March 17, 2008
Last Updated:	August 11, 2009
ClinicalTrials.gov Identifier:	NCT00640588 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Novartis:

Hepatitis B, chronic
Viral kinetics
Telbivudine
Adefovir
Compliance

Study placed in the following topic categories:

Anti-Infective Agents
Liver Diseases
Hepatitis, Chronic
Hepatitis, Viral, Human
Antiviral Agents
Reverse Transcriptase Inhibitors
Hepatitis
Virus Diseases

Digestive System Diseases
Anti-Retroviral Agents
Hepatitis B, Chronic
Hepatitis B
DNA Virus Infections
Adefovir dipivoxil
Adefovir

Additional relevant MeSH terms:

Anti-Infective Agents
Liver Diseases
Molecular Mechanisms of Pharmacological Action
Hepatitis, Chronic
Hepatitis, Viral, Human
Enzyme Inhibitors
Hepadnaviridae Infections
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Hepatitis

Virus Diseases
Digestive System Diseases
Anti-Retroviral Agents
Therapeutic Uses
Hepatitis B, Chronic
Hepatitis B
DNA Virus Infections
Adefovir dipivoxil
Adefovir
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 10, 2009