A Non-interventional Retrospective Study of the Current T... | NCT02049099

Studies
A Non-interventional Retrospective Study of the Current Treatment Practice in European Haemophilia Care

NCT02049099

Sponsor

Swedish Orphan Biovitrum

Status

Completed

Last Update Posted

Mar 14, 2016Estimated

Enrollment

1,658Actual

Phase

Not provided

Conditions

Haemophilia A
Haemophilia B

Interventions

Not provided

Countries

Belgium
France
Germany
Italy
Spain
Sweden
United Kingdom

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

Mar 2016

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

Mar 2014

Primary Completion Date

Sep 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Jan 28, 2014

First Submission Date that Met QC Criteria

Jan 28, 2014

First Posted Date

Jan 29, 2014Estimated

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

Mar 11, 2016

Last Update Posted Date

Mar 14, 2016Estimated

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

To describe the current treatment practice during 12 months for previously treated patients diagnosed with haemophilia A or haemophilia B.

Detailed Description

The study population consists of patients with a diagnosis of ICD10: haemophilia A D66.9 or haemophilia B D67.9.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,658Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total dose (IU) issued of Factor VIII during a 12 month period		- 12 month to Day 0
Total dose (IU) issued of Factor IX during a 12 month period		- 12 month to Day 0

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male patients with severe or moderate haemophilia A or haemophilia B.
Treatment with Factor VIII/Factor IX products initiated at least 24 months before inclusion in the study.
Informed consent is obtained from the patient or patient's legal representative (as applicable according to legal regulation).

Exclusion Criteria:

Confirmed positive inhibitor test detected in the past 24 months.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The study population consists of patients with a diagnosis of ICD10: haemophilia A D66.9 or haemophilia B D67.9.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stefan Lethagen, MD	Swedish Orphan Biovitrum AB (publ)	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Swedish Orphan Biovitrum Investigational Site		Brussels			Belgium
Swedish Orphan Biovitrum Investigational Site

Condition Browse Module

MeSH Terms

ID	Term
D006467	Hemophilia A
D002836	Hemophilia B

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