Hepatitis ENCT03601221
Seroprevalence Hepatitis E Infection in Healthy Blood Donors
An observational study of Hepatitis E, run by Ente Ospedaliero Cantonale, Bellinzona at 1 site in Switzerland.
Trial summary
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis E
- What is being tested?
- Sample collection
- How many people
- 1,447 participants
- Where
- 1 siteSwitzerland
- Study dates
- 29 May 2018to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Healthy and voluntary blood donors
Who may be able to join
- Healthy and voluntary blood donors
- Subjects living in the Canton Ticino
- Signed informed consent of the STCRS SI for blood donation
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study on Seroprevalence of Hepatitis E Infection in Healthy Blood Donors in the Canton Ticino
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).
Read the detailed description
Pre-donation sampling pouch of fresh and stored frozen plasma collected within the last 5 years will be tested for HEV IgG serology at the National Reference Laboratory of the Blood Transfusion Services SRC in Berne Collected data will be used to determine HEV seroprevalence, actual and in the last 5 years, in the Canton Ticino and to investigate trend and pattern of the HEV infection (seroprevalence by different regional areas, comparison with national HEV data, and correlation with age, sex and place of residence).
- Conditions
- Hepatitis E
- Being tested
- Sample collection
- Medical subject headings
- Hepatitis E
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample collectionOther
Collection of one sampling pouch from each blood donor
What is being measured
The primary outcome is the main question the study is designed to answer.
HEV blood incidence
HEV incidence assessed through a single periferal blood sample from each donor
Measured: One year
Secondary outcomes (3)
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.
Measured: Five years
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
Measured: Five years
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
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start29 May 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis EStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,447 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ente Ospedaliero Cantonale, Bellinzona
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Transfusion SRC, Clinical Trial Unit Ente Ospedaliero Cantonale
- Responsible party
- Sponsor
- Investigators
- Florian Bihl, MD, Study director, Ente Ospedaliero Cantonale, Bellinzona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601221
- Sponsor's protocol ID
- HEV-TI-2018
- Status last verified
- Mar 2020
- First submitted
- 5 Jul 2018
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Seroprevalence of Hepatitis E Infection in Healthy Blood Donors in the Canton Ticino
- ClinicalTrials.gov ID
- NCT03601221
- Acronym / sponsor ID
- HEV-TI-2018
- Conditions
- Hepatitis E
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,447 participants (actual)
- Lead sponsor
- Ente Ospedaliero Cantonale, BellinzonaUniversity, hospital or other
- Collaborators
- Swiss Transfusion SRC, Clinical Trial Unit Ente Ospedaliero Cantonale
- Study start
- 29 May 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Pre-donation sampling pouch of fresh and stored frozen plasma collected within the last 5 years will be tested for HEV IgG serology at the National Reference Laboratory of the Blood Transfusion Services SRC in Berne Collected data will be used to determine HEV seroprevalence, actual and in the last 5 years, in the Canton Ticino and to investigate trend and pattern of the HEV infection (seroprevalence by different regional areas, comparison with national HEV data, and correlation with age, sex and place of residence).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy and voluntary blood donors
Key inclusion criteria (3 listed)
- Healthy and voluntary blood donors
- Subjects living in the Canton Ticino
- Signed informed consent of the STCRS SI for blood donation
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sample collectionCollection of one sampling pouch from each blood donor | Other | – |
Primary outcome
HEV blood incidence
Time frame: One year
HEV incidence assessed through a single periferal blood sample from each donor
3 secondary outcomes
change in the blood incidence of HEV
Time frame: Five years
Geogarphical distribution of the HEV measured in the blood sample
Time frame: Five years
Trend of the HEV infection measured in the blood sample
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florian Bihl, MD study director
Ente Ospedaliero Cantonale, Bellinzona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis E, run by Ente Ospedaliero Cantonale, Bellinzona at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HEV blood incidence (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.