Epidemiological Study on Haemophilia Care and Orthopaedic Status in Developing Countries (HAEMOcare)

Novo Nordisk

Status: Completed

Conditions: Haemophilia B With Inhibitors; Haemophilia B; Haemophilia A With Inhibitors; Haemophilia A; Congenital Bleeding Disorder

Treatments: Other: No treatment given

Study type: Observational

Funder types: Industry

Identifiers

NCT01503567

HAEM-3971

U1111-1124-6665 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 282 patients

Sex: Male

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

282 participants in 4 patient groups

Subjects 6 to 18 years old without inhibitors

Treatment:

Other: No treatment given

Subjects 6 to 18 years old with inhibitors

Treatment:

Other: No treatment given

Subjects above18 years old without inhibitors

Treatment:

Other: No treatment given

Subjects above 18 years old with inhibitors

Treatment:

Other: No treatment given