Family Study HbA2 Leuven Mutation.HbA2 LeuvenNCT01909648
HbA2 Leuven and Its Impact on HbA1c Results
A study testing Blood withdrawal in people with Family Study HbA2 Leuven Mutation., run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The study is designed to demonstrate HbA2 Leuven mutation and to asssess its impact on routine HbA1c measurements. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Family Study HbA2 Leuven Mutation.
- What is being tested?
- Blood withdrawal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2013to Feb 2014
- Phase
- Interventional
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Family history of HbA2 Leuven mutation.
Who cannot join
- Any condition inhibiting simple blood withdrawal.
Trial locations and contacts
1 site in 1 country.
About this study
The study is designed to demonstrate HbA2 Leuven mutation and to asssess its impact on routine HbA1c measurements.
Read the detailed description
HbA2 Leuven mutation will be investigated using molecular diagnostic techniques.
Interference on HbA1c measurements will be assessed in HbA2 Leuven carriers using different methodologies.
- Conditions
- Family Study HbA2 Leuven Mutation.
- Being tested
- Blood withdrawal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood withdrawalOther
Also called Impact of mutation on routine HbA1c measurements.
Blood withdrawalGenetic
Also called Demonstration of HbA2 Leuven mutation
| Study group | Role | What they receive |
|---|---|---|
| HbA2 Leuven | Other | Presence of HbA2 Leuven mutation, demonstrated by molecular diagnosis on blood sample. Receives: Other: Blood withdrawal; Genetic: Blood withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstration of presence/absence of HbA2 Leuven mutation
Measured: 1 year
Secondary outcomes (1)
Demonstration of impact of HbA2 Leuven mutation on routine HbA1c measurements
Measured: 1 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 2013 (estimated)
- Study startSep 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family Study HbA2 Leuven Mutation.Studies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Davy MJ Kieffer, PhD, Principal investigator, Universitaire Ziekenhuizen KU LeuvenPieter Gillard, MD, PhD, Study chair, Universitaire Ziekenhuizen KU LeuvenKoen Desmet, PharmD, Study chair, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909648
- Sponsor's protocol ID
- S55709
- Other IDs
- S55709
- Acronym
- HbA2 Leuven
- Status last verified
- Jul 2015
- First submitted
- 24 Jul 2013
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HbA2 Leuven and Its Impact on HbA1c Results
- ClinicalTrials.gov ID
- NCT01909648
- Acronym / sponsor ID
- HbA2 Leuven / S55709
- Conditions
- Family Study HbA2 Leuven Mutation.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 26 Jul 2013 (estimated)
- 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.
The study is designed to demonstrate HbA2 Leuven mutation and to asssess its impact on routine HbA1c measurements.
Detailed description
HbA2 Leuven mutation will be investigated using molecular diagnostic techniques.
Interference on HbA1c measurements will be assessed in HbA2 Leuven carriers using different methodologies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HbA2 Leuven | Other | Other: Blood withdrawal, Genetic: Blood withdrawalPresence of HbA2 Leuven mutation, demonstrated by molecular diagnosis on blood sample. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Family history of HbA2 Leuven mutation.
Key exclusion criteria (1 listed)
- Any condition inhibiting simple blood withdrawal.
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 |
|---|---|---|
| Blood withdrawalAlso: Impact of mutation on routine HbA1c measurements. | Other | HbA2 Leuven |
| Blood withdrawalAlso: Demonstration of HbA2 Leuven mutation | Genetic | HbA2 Leuven |
Primary outcome
Demonstration of presence/absence of HbA2 Leuven mutation
Time frame: 1 year
1 secondary outcome
Demonstration of impact of HbA2 Leuven mutation on routine HbA1c measurements
Time frame: 1 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 7 Jul 2015.
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.
Davy MJ Kieffer, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
Pieter Gillard, MD, PhD study chair
Universitaire Ziekenhuizen KU Leuven
Koen Desmet, PharmD study chair
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood withdrawal in people with Family Study HbA2 Leuven Mutation., run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 1 inclusion and 1 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 7 Jul 2015. 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 Belgium. 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?
Demonstration of presence/absence of HbA2 Leuven mutation (time frame: 1 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 7 Jul 2015.