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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00640588 |
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Date of registration:
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17/03/2008 |
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Primary sponsor: |
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Public title:
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Prospective Exploratory Study to Describe Hepatitis B Virus (HBV) Kinetics During Treatment With Telbivudine
EBEREST |
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Scientific title:
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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 |
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Date of first enrolment:
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March 2008 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00640588 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label
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Countries of recruitment
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Spain
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Contacts
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Name:
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Novartis |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hepatitis B, Chronic
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Intervention(s)
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Drug: oral adefovir
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Drug: Telbivudine
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Primary Outcome(s)
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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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Secondary Outcome(s)
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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]
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Secondary ID(s)
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CLDT600AES01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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