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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: |
NCT02876419 |
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Date of registration:
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16/08/2016 |
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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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A Long Term Follow-up Study of Patients From the REP 301 Protocol
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Scientific title:
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A Long Term Follow-up Study of Patients From the REP 301 Protocol |
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Date of first enrolment:
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August 2016 |
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Target sample size:
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11 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02876419 |
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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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Moldova, Republic of
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Contacts
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Name:
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Victor Pantea, 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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Infectious Clinical Hospital (n.a. Toma Ciorba) |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Signed written informed consent.
Exclusion Criteria:
1. Any patients not enrolled in the REP 301 protocol or not successfully completing all
treatment and follow-up visits in the REP 301 protocol
2. A history of alcohol abuse within the last year
3. The use of illicit drugs within the past two years.
4. Inability to provide informed consent.
5. Inability or unwillingness to provide blood samples.
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hepatitis B, Chronic
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Hepatitis D, Chronic
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Primary Outcome(s)
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Long term safety (AEs)
[Time Frame: 3 years]
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Long term safety (SAEs)
[Time Frame: 3 years]
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Long term safety (test abnormalities)
[Time Frame: 3 years]
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Secondary Outcome(s)
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Long term efficacy (serum anti-HBs)
[Time Frame: 3 years]
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Long term efficacy (serum HBV DNA)
[Time Frame: 3 years]
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Long term efficacy (serum HBsAg)
[Time Frame: 3 years]
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Long term efficacy (serum HDV RNA)
[Time Frame: 3 years]
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Secondary ID(s)
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REP 301-LTF
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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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