NCT01909648

Brief Summary

The study is designed to demonstrate HbA2 Leuven mutation and to asssess its impact on routine HbA1c measurements.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

July 7, 2015

Status Verified

July 1, 2015

Enrollment Period

5 months

First QC Date

July 24, 2013

Last Update Submit

July 6, 2015

Conditions

Family Study HbA2 Leuven Mutation.

Outcome Measures

Primary Outcomes (1)

  • Demonstration of presence/absence of HbA2 Leuven mutation

    1 year

Secondary Outcomes (1)

  • Demonstration of impact of HbA2 Leuven mutation on routine HbA1c measurements

    1 year

Study Arms (1)

HbA2 Leuven

OTHER

Presence of HbA2 Leuven mutation, demonstrated by molecular diagnosis on blood sample.

Other: Blood withdrawalGenetic: Blood withdrawal

Interventions

Blood withdrawalOTHER
Also known as: Impact of mutation on routine HbA1c measurements.
HbA2 Leuven

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Family history of HbA2 Leuven mutation.

You may not qualify if:

  • Any condition inhibiting simple blood withdrawal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZLeuven

Leuven, Belgium

Location

Study Officials

  • Davy MJ Kieffer, PhD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

  • Pieter Gillard, MD, PhD

    Universitaire Ziekenhuizen KU Leuven

    STUDY CHAIR

  • Koen Desmet, PharmD

    Universitaire Ziekenhuizen KU Leuven

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2013

First Posted

July 26, 2013

Study Start

September 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

July 7, 2015

Record last verified: 2015-07

Locations

BE(1)