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Completed

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)

Completed

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Key information

Conditions

Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Age range

2 year–18 year

Sex eligibility

Male

Study type

Observational

Primary location

Many Locations, China

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

Biological

Depends on Doctor's decision

Primary outcomes

  1. Duration of regular prophylaxis

    Time frame: Up to 1.5 years

  2. Prophylaxis infusion dose

    Time frame: Up to 1.5 years

  3. Percentage of rFVIII usage in prophylaxis

    Time frame: Up to 1.5 years

Secondary outcomes

  1. Bleeding frequency

    Time frame: Up to 1.5 years

  2. Joint radiographic score

    Time frame: Up to 1.5 years

  3. Joint physical examination score

    Time frame: Up to 1.5 years

  4. Quality of life by questionnaire

    Time frame: Up to 1.5 years

Sponsors 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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