Evaluation of the Reasons and Consequences of Bleeding in... | NCT00782470

Studies
Evaluation of the Reasons and Consequences of Bleeding in Late Teens and Early Adulthood Patients With Severe Hemophilia A

NCT00782470

Sponsor

Bayer

Status

Completed

Last Update Posted

Nov 3, 2014Estimated

Enrollment

38Actual

Phase

Not provided

Conditions

Hematologic Disease
Blood Coagulation Disorders

Interventions

Recombinant Factor VIII (Kogenate, BAY 14-2222)
Recombinant Factor VIII (Kogenate, BAY 14-2222)
Recombinant Factor VIII (Kogenate, BAY 14-2222)

Countries

United States
Canada
Germany
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

Status Module

Record Verification Date

Oct 2014

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 2007

Primary Completion Date

Nov 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

Oct 29, 2008

First Submission Date that Met QC Criteria

Oct 29, 2008

First Posted Date

Oct 31, 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

Oct 31, 2014

Last Update Posted Date

Nov 3, 2014Estimated

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

Understanding how often the bleeding events occur in the subjects who voluntarily decide to switch from prophylaxis to on-demand and in those subjects who remain on prophylaxis. Also look into the consequences of switching treatment in QoL (quality of life), development of target joints, activity level and reasons that might influence the desire to switch.

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

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1			Behavioral: Recombinant Factor VIII (Kogenate, BAY 14-2222)
Group 2			Behavioral: Recombinant Factor VIII (Kogenate, BAY 14-2222)
Group 3			Behavioral: Recombinant Factor VIII (Kogenate, BAY 14-2222)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Recombinant Factor VIII (Kogenate, BAY 14-2222)	Behavioral	Subjects electing to stay on the prophylactic treatment (prospective)	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the frequency of all bleeds (spontaneous and trauma) during the study		End of Study

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the change from baseline in HRQoL (health-related quality of life)		End of Study
To evaluate number of patients that want to return to prophylaxis treatment after having switched to on-demand therapy		End of Study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Severe hemophilia A (<2%)
For subjects who elect staying on Prophylaxis only: Have been on continuous prophylactic treatment for the past 5 years prior to study entry
For subjects who elect switching to on-demand only: Have been on continuous prophylactic treatment for the past 5 years, but may have been on intermediate or reduced prophylaxis for the 1-12 months prior to study entry
For subjects currently on-demand: a retrospective arm of subjects who have been on continuous prophylactic treatment for at least 5 years and switched to on-demand treatment between 13 and 24 months prior to study entry
Current treatment with rFVIII

Exclusion Criteria:

Other known hematological / bleeding disorders other than hemophilia A
Participating on another study that may have an impact on bleeding or the objectives of this study
Known alcohol and drug abuse

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

29 Years

Standard Ages

ChildAdult

Study Population

Cohort 1 - Prospective Prophylaxis Group Cohort 2 - Prospective On-demand Group Cohort 3 - Retrospective On-demand Group

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Duarte	California	91010	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23750875	Result	Manco-Johnson MJ, Sanders J, Ewing N, Rodriguez N, Tarantino M, Humphries T; TEEN/TWEN Study Group. Consequences of switching from prophylactic treatment to on-demand treatment in late teens and early adults with severe haemophilia A: the TEEN/TWEN study. Haemophilia. 2013 Sep;19(5):727-35. doi: 10.1111/hae.12177. Epub 2013 Jun 11.

ID	Term
D006402	Hematologic Diseases
D001778	Blood Coagulation Disorders

ID	Term
D005169	Factor VIII
C078147	F8 protein, human
C414350	BAY 14-2222

ID	Term
D001779	Blood Coagulation Factors
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D011498	Protein Precursors
D001685	Biological Factors