Brief Title
Epidemiological Study on Haemophilia Care and Orthopaedic Status in Developing Countries
Official Title
Epidemiological Study on Haemophilia Care and Orthopaedic Status in Developing Countries
Brief Summary
This study is conducted in Africa and Asia. The aim of this study is to evaluate in the participating countries the orthopaedic status and the degree of arthropathy of severe haemophilia patients in general.
Study Type
Observational
Primary Outcome
Type of haemophilia and inhibitor characteristics: Against FVIII or FIX; high or low titre; anamnestic response (high or low responder)
Secondary Outcome
Mean orthopaedic score in the 4 groups according to the Pettersson and Haemophilia joint scores
Condition
Congenital Bleeding Disorder
Intervention
No treatment given
Study Arms / Comparison Groups
Subjects 6 to 18 years old without inhibitors
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
282
Start Date
January 2012
Completion Date
September 2012
Primary Completion Date
September 2012
Eligibility Criteria
Inclusion Criteria: - Patient (and/or parents or the patient's legally acceptable representative, if applicable) must give signed and dated informed consent before enrolment in the study - Male patients at least 6 years old with diagnosis of severe congenital haemophilia A or B with or without inhibitors - Patients receiving on demand replacement factors/bypassing agents therapy Exclusion Criteria: - Clinically relevant coagulation disorders other than congenital haemophilia A or B - Patients on currently active treatment for HCV (Hepatitis C Virus) or HIV (Human Immune Deficiency Virus) infections
Gender
Male
Ages
6 Years - 18 Years
Accepts Healthy Volunteers
No
Contacts
Global Clinical Registry (GCR, 1452), ,
Location Countries
India
Location Countries
India
Administrative Informations
NCT ID
NCT01503567
Organization ID
HAEM-3971
Secondary IDs
U1111-1124-6665
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S
Verification Date
January 2017