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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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12 December 2020 |
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Main ID: |
NCT02889094 |
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Date of registration:
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25/08/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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French HIV-HBV Cohort
COVViB |
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Scientific title:
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Multi-center Study Evaluating Persistence of Hepatitis B Virus Replication, Long-term Prognostic Indicators and Their Clinical Relevance in Patients Co-infected With the Human Immunodeficiency Virus and Chronic Hepatitis B |
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Date of first enrolment:
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October 2016 |
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Target sample size:
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152 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT02889094 |
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Study type:
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Observational |
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Study design:
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Phase:
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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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Anders Boyd, MPH, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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INSERM UMR S 1136 |
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Name:
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Karine Lacombe, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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INSERM UMR S 1136 |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- HBsAg seropositivity for >6 months (at initial cohort inclusion)
- HIV-positive serology confirmed with Western blot (at initial cohort inclusion)
- Karnofsky score >70 (at initial cohort inclusion)
- Age =18 years old (at initial cohort inclusion)
- Completed follow-up in at least one previous study phase of the French HIV-HBV Cohort
- Obtained signed written informed consent
Exclusion Criteria:
- Refusal to participate
- Any severe physical, clinical or mental condition preventing participation
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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End Stage Liver Disease
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Hepatitis B
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Liver Cirrhosis
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HIV
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Intervention(s)
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Other: Routine care
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Primary Outcome(s)
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HBeAg-seroclearance
[Time Frame: 14 years]
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HBsAg-seroclearance
[Time Frame: 14 years]
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Liver fibrosis (FibroScan)
[Time Frame: 14 years]
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Liver fibrosis (FibroTest)
[Time Frame: 14 years]
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HBV DNA replication
[Time Frame: 14 years]
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Secondary Outcome(s)
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Liver-related morbidity
[Time Frame: 14 years]
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Liver-related mortality
[Time Frame: 14 years]
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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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