HbA2 Leuven and Its Impact on HbA1c Results | NCT01909648

Studies
HbA2 Leuven and Its Impact on HbA1c Results

NCT01909648

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Last Update Posted

Jul 7, 2015Estimated

Enrollment

10Actual

Phase

Not Applicable

Conditions

Family Study HbA2 Leuven Mutation.

Interventions

Blood withdrawal
Blood withdrawal

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
S55709	Other Identifier	UZLeuven

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

Jul 24, 2013

First Submission Date that Met QC Criteria

Jul 24, 2013

First Posted Date

Jul 26, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2015

Last Update Posted Date

Jul 7, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HbA2 Leuven	Other	Presence of HbA2 Leuven mutation, demonstrated by molecular diagnosis on blood sample.	Other: Blood withdrawal Genetic: Blood withdrawal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood withdrawal	Other		HbA2 Leuven	Impact of mutation on routine HbA1c measurements.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Demonstration of presence/absence of HbA2 Leuven mutation		1 year

Secondary Outcomes

Measure	Description	Time Frame
Demonstration of impact of HbA2 Leuven mutation on routine HbA1c measurements		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Family history of HbA2 Leuven mutation.

Exclusion Criteria:

Any condition inhibiting simple blood withdrawal.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZLeuven		Leuven			Belgium

Type	Date	Date Unknown
Release	May 2, 2017
Reset	Sep 15, 2017