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

Blood Coagulation Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00782470
• Other study ID #: 12749
• Status: Completed
• Phase: N/A
• First received: October 29, 2008
• Last updated: October 31, 2014
• Start date: December 2007
• Est. completion date: November 2010

Study information

• Verified date: October 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Aspire Independent Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 14 Years to 29 Years

Eligibility

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

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Hematologic Disease
• Hematologic Diseases
• Hemophilia A
• Hemostatic Disorders

Intervention

Behavioral:
• Recombinant Factor VIII (Kogenate, BAY 14-2222)
Subjects electing to stay on the prophylactic treatment (prospective)
• Recombinant Factor VIII (Kogenate, BAY 14-2222)
Subjects electing to switch to on-demand treatment (prospective)
• Recombinant Factor VIII (Kogenate, BAY 14-2222)
Subjects remaining on-demand treatment (retrospective)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Canada,  Germany,  United Kingdom, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the frequency of all bleeds (spontaneous and trauma) during the study		End of Study	No
Secondary	To evaluate the change from baseline in HRQoL (health-related quality of life)		End of Study	No
Secondary	To evaluate number of patients that want to return to prophylaxis treatment after having switched to on-demand therapy		End of Study	No
Secondary	To evaluate the change from baseline in the Gilbert score		End of Study	No
Secondary	To evaluate the number of target joint development		End of Study	No

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
•   Click here to find results for studies related to Bayer Healthcare products.