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Main
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Note: This record shows only 22 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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19 February 2015 |
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Main ID: |
NCT00199732 |
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Date of registration:
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14/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of cccDNA and Total HBV DNA Kinetics in Lymphocytes, Total Blood and Serum in Chronic Hepatitis B Patients Treated With Adefovir Dipivoxil and Peg Interferon Alpha 2a
DNA-EVAL |
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Scientific title:
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Evaluation of cccDNA and Total HBV DNA Kinetics in Lymphocytes, Total Blood and Serum in Chronic Hepatitis B Patients Treated With Adefovir Dipivoxil and Peg Interferon Alpha 2a |
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Date of first enrolment:
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December 2004 |
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Target sample size:
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19 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00199732 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Véronique Loustaud-Ratti, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Limoges |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male and female patients >18 years of age and <70 years of age
- Patients AgHbs+ and AgHbe+ or AgHbe-, and B viral DNA >104 copies/ml PCR COBAS
MONITOR
- Patients treated with adefovir dipivoxil and peg interferon alpha 2a
- Chronic liver disease consistent with chronic hepatitis B infection on a biopsy
obtained within the past 24 months
- Naïve patients or patients having a relapse or a therapeutic failure after
monotherapy lamivudine or interferon, or bitherapy interferon alpha-lamivudine
Exclusion Criteria:
- Co-infection HIV, HCV
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Hepatitis B
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Primary Outcome(s)
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Kinetic cccDNA
[Time Frame: 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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