Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Retrospective Study in Chinese Pediatric Hemophilia A Patients With rFⅧ Contained Regular Prophylaxis (ReCARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02263066
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : July 17, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
To assess and describe real-life treatment choices for rFⅧ contained regular prophylaxis/bleeding prevention treatment in pediatric hemophilia patients in China (2007-2013)

Condition or disease Intervention/treatment
Hemophilia A Biological: BAY14-2222_Kogenate-FS FVIII

Layout table for study information
Study Type : Observational
Actual Enrollment : 181 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrospective Study in Chinese Pediatric Hemophilia A Patients With rFⅧ Contained Regular Prophylaxis
Study Start Date : October 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

Group/Cohort Intervention/treatment
Group 1
Chinese hemophilia A pediatric patients with medical records who had accepted regular prophylaxis, totally/partially with rFⅧ between Nov. 1st 2007 and May 31st 2013
Biological: BAY14-2222_Kogenate-FS FVIII
Depends on Doctor's decision




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
About 300 at most hemophilia boys (2-<18 years) in the representative hemophilia treatment centers (HTCs) with available medical data record, having received rFVIII contained regular prophylaxis between Nov. 1st 2007 and May 31st 2013 will be enrolled from about 15 centers.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02263066


Locations
Layout table for location information
China
Many Locations, China
Sponsors and Collaborators
Bayer
Investigators
Layout table for investigator information
Study Director: Bayer Study Director Bayer
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02263066    
Other Study ID Numbers: 17653
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: July 17, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants