Hepatitis E Clinical Trial
Official title:
Observational Study on Seroprevalence of Hepatitis E Infection in Healthy Blood Donors in the Canton Ticino
NCT number | NCT03601221 |
Other study ID # | HEV-TI-2018 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 29, 2018 |
Est. completion date | December 31, 2019 |
Verified date | March 2020 |
Source | Ente Ospedaliero Cantonale, Bellinzona |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is a HEV seroprevalence in the health donors in the Canton Ticino study. The pre-donation sampling pouch of each blood donor coming form the Cantone Ticino region will be collected and tested for HEV serology (IgM and IgG).
Status | Completed |
Enrollment | 1447 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Healthy and voluntary blood donors - Subjects living in the Canton Ticino - Inclusion criteria for blood donation - Signed informed consent of the STCRS SI for blood donation Exclusion Criteria: - Exclusion criteria for blood donation |
Country | Name | City | State |
---|---|---|---|
Switzerland | Swiss Transfusion SRC Canton Ticino | Lugano, |
Lead Sponsor | Collaborator |
---|---|
Ente Ospedaliero Cantonale, Bellinzona | Clinical Trial Unit Ente Ospedaliero Cantonale, Swiss Transfusion SRC |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HEV blood incidence | HEV incidence assessed through a single periferal blood sample from each donor | One year | |
Secondary | change in the blood incidence of HEV | Determine the change in the incidence of HEV in the Canton Ticino region in the last 5 years analysing the blood sample of the donors. | Five years | |
Secondary | Geogarphical distribution of the HEV measured in the blood sample | Determination of the distribution of the HEV infection in different geographical areas of the Canton Ticino analysing donor blood samples | Five years | |
Secondary | Trend of the HEV infection measured in the blood sample | Evaluation of the trend of the HEV infection in the CantoneTicino compared to other Swiss cantons | One year |
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