- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00640588
Prospective Exploratory Study to Describe Hepatitis B Virus (HBV) Kinetics During Treatment With Telbivudine (EBEREST)
March 24, 2017 updated by: Novartis Pharmaceuticals
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
This study will explore HBV kinetics in CHB patients during the first 24 weeks of treatment with telbivudine
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 3
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
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Barcelona, Spain
- Novartis Investigative Site
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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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Telbivudine
|
Arm 1: 600 mg/day, oral telbivudina for 24 weeks
Other Names:
|
Active Comparator: 2
Arm 2: 600 mg/day, oral telbivudina plus 10 mg/day oral adefovir for 24 weeks
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Arm 2: 600 mg/day, oral telbivudina plus 10 mg/day oral adefovir for 24 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
March 17, 2008
First Submitted That Met QC Criteria
March 20, 2008
First Posted (Estimate)
March 21, 2008
Study Record Updates
Last Update Posted (Actual)
March 28, 2017
Last Update Submitted That Met QC Criteria
March 24, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Telbivudine
- Adefovir
- Adefovir dipivoxil
Other Study ID Numbers
- CLDT600AES01
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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