Many Locations, China
NCT Number: NCT02263066
Retrospective Study in Chinese Pediatric Hemophilia A Patients With rFⅧ Contained Regular Prophylaxis
To assess and describe real-life treatment choices for rFⅧ contained regular prophylaxis/bleeding prevention treatment in pediatric hemophilia patients in China (2007-2013)
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Notify MeKey information
Conditions
Age range
2 year–18 year
Sex eligibility
Male
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Male, 2-<18 years Hemophilia A, based on documented prior testing and/or screening laboratory Patients who had received regular prophylaxis/bleeding prevention treatment, totally/partially with rFⅧ. Regular prophylaxis/bleeding prevention treatment is defined as that proportion of weeks (≥2 infusion/week) of total treatment weeks≥80%[10] , and total duration ≥12 weeks. During the regular prophylaxis period, if there were consecutive 4 weeks that <2 infusion/week, the beginning day of the 4 weeks is defined as the end of regular prophylaxis.
Available patient medical data record Written informed consent by parent/legal representative. Consent should be sought from subjects if appropriate
Exclusion criteria
- Patients with measurable inhibitor activity at baseline and history of FVIII inhibitor antibody formation (≥0.6BU by Bethesda assay at two different time points, documentation must be available) Any individuals with another bleeding disease that is different from hemophilia A (e.g, von Willebrand disease, hemophilia B)
Treatment and study plan
BAY14-2222_Kogenate-FS FVIII
BiologicalDepends on Doctor's decision
Primary outcomes
-
Duration of regular prophylaxis
Time frame: Up to 1.5 years
-
Prophylaxis infusion dose
Time frame: Up to 1.5 years
-
Percentage of rFVIII usage in prophylaxis
Time frame: Up to 1.5 years
Secondary outcomes
-
Bleeding frequency
Time frame: Up to 1.5 years
-
Joint radiographic score
Time frame: Up to 1.5 years
-
Joint physical examination score
Time frame: Up to 1.5 years
-
Quality of life by questionnaire
Time frame: Up to 1.5 years
Interested in participating?
Looking for future studies?
Notify MeSponsors and collaborators
Lead sponsor
Bayer
Industry
Registry information
Acronym: ReCARE
Important dates
- Study start
- 2014
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Oct 13, 2014
- Registry last updated
- Jul 17, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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