Evaluation of the Reasons and Consequences of Bleeding in Late Teens and Early Adulthood Patients With Severe Hemophilia A
A Prospective, Non-interventional, Multi-center, Open-label Study to Evaluate the Reasons and Consequences of Bleeding in Late Teens and Early Adulthood Subjects With Severe Hemophilia A Receiving Prophylaxis and On-demand Treatment Regimen
1 other identifier
observational
38
4 countries
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2007
Typical duration for all trials
10 active sites
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
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 29, 2008
CompletedFirst Posted
Study publicly available on registry
October 31, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedNovember 3, 2014
October 1, 2014
2.9 years
October 29, 2008
October 31, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
To evaluate the frequency of all bleeds (spontaneous and trauma) during the study
End of Study
Secondary Outcomes (4)
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
To evaluate the change from baseline in the Gilbert score
End of Study
To evaluate the number of target joint development
End of Study
Study Arms (3)
Group 1
Group 2
Group 3
Interventions
Subjects electing to stay on the prophylactic treatment (prospective)
Eligibility Criteria
Cohort 1 - Prospective Prophylaxis Group Cohort 2 - Prospective On-demand Group Cohort 3 - Retrospective On-demand Group
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (10)
Unknown Facility
Duarte, California, 91010, United States
Unknown Facility
Denver, Colorado, 80262, United States
Unknown Facility
Peoria, Illinois, 61614, United States
Unknown Facility
Jefferson City, Missouri, 65109, United States
Unknown Facility
Las Vegas, Nevada, 89109, United States
Unknown Facility
Fort Worth, Texas, 76104, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Many Locations, Canada
Unknown Facility
Many Locations, Germany
Unknown Facility
Many Locations, United Kingdom
Related Publications (1)
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.
PMID: 23750875RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2008
First Posted
October 31, 2008
Study Start
December 1, 2007
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
November 3, 2014
Record last verified: 2014-10