A Feasibility Study to Collect Data in Patients With Haem... | NCT00798499

Studies
A Feasibility Study to Collect Data in Patients With Haemophilia

NCT00798499

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jul 2, 2009Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Hemophilia

Interventions

Laboratory variables

Countries

Sweden

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

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

Dec 2008

Primary Completion Date

Not provided

Completion Date

Jun 2009Actual

First Submitted Date

Nov 12, 2008

First Submission Date that Met QC Criteria

Nov 25, 2008

First Posted Date

Nov 26, 2008Estimated

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 1, 2009

Last Update Posted Date

Jul 2, 2009Estimated

Description Module

Brief Summary

The purpose of this study is to collect reference data in patients with haemophilia. The study will also collect and store blood samples for potential future exploratory research in the disease area.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Laboratory variables	Other: Laboratory variables

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laboratory variables	Other	1 visit	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Laboratory variables related to coagulation, SAEs in connection to blood sampling procedures will be collected, non-serious AEs will not be recorded		The variables will be measured at first visit.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Provision of written informed consent
Patients with haemophilia, all severities
At least 18 years old.

Exclusion Criteria:

No exclusion criteria

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with haemophilia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erik Berntorp, MD, PhD, Professor	Malmo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Malmö			Sweden
Research Site

Condition Browse Module

MeSH Terms

ID	Term
D006467	Hemophilia A

Ancestor Terms

ID	Term
D025861	Blood Coagulation Disorders, Inherited
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided