Trial Condition(s):
Hematologic disease, Blood Coagulation Disorders
Evaluation of the Reasons and Consequences of Bleeding in Late Teens and Early Adulthood Patients With Severe Hemophilia A
Bayer Identifier:
12749
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Germany | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hemophilia Treatment Center of Las Vegas Las Vegas, United States, 89109 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gulf States Hemophilia & Thrombophilia Center Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Capitol Comprehensive Cancer Center Jefferson City, United States, 65109 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations City of Hope National Medical Center Duarte, United States, 91010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Comprehensive Bleeding Disorder Center Peoria, United States, 61614 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Canada | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Colorado Health Sciences Center Denver, United States, 80262 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cook Children's Medical Center Fort Worth, United States, 76104 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, United Kingdom | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Observational
Intervention Type:
Behavioral
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
3
Primary Outcome
- To evaluate the frequency of all bleeds (spontaneous and trauma) during the studyTimeframe: End of Study
Secondary Outcome
- To evaluate the change from baseline in HRQoL (health-related quality of life)Timeframe: End of Study
- To evaluate number of patients that want to return to prophylaxis treatment after having switched to on-demand therapyTimeframe: End of Study
- To evaluate the change from baseline in the Gilbert scoreTimeframe: End of Study
- To evaluate the number of target joint developmentTimeframe: End of Study
Additional Information
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