Pharmacokinetic evaluation of a new formulation of recombinant factor IX (BeneFIX) in the italian population with severe or moderate B haemophilia previously treated. - ND

• Conditions: Patients with severe or moderate B Haemophilia, previously treated with rFIX.; MedDRA version: 9.1Level: SOCClassification code 10010331

• Registration Number: EUCTR2008-006465-85-IT
• Lead Sponsor: AZIENDA OSPEDALIERA UNIVERSITARIA CAREGGI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1.Severe or moderate B haemophilia (factor IX activity < 5 %);

2.Male patients older than 6 years;

3.Patients previously treated with rFIX.

4.Written informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patients ongoing treatment with plasmaderived factor IX (pd-FIX);

2.For patients with documented HIV infection, CD4 count <200 and/or in
HAART therapy;

3.Patients with liver or renal disease (ALT and AST 2.5x ULN, bilirubin >2
mg/dL, seric albumin <3.5 g/L seric creatinin >1.25 x ULN);

4.Prothrombin Time >1.5 x ULN;

5.Platelet count < 150.000/µL;

6.Patients with current or past inhibitors to factor IX;

7.Patients with history of hypersensitivity to FIX or to eccipients, or to Hamster proteins;

8 Exposure to other experimental drugs, eccept BeneFIX, in the 30 days prior to the sign of the informed consent of this study;

9.Patients with coagulation disorders/diseases different from B haemophilia;

10.Inflammatory disease documented and still present, which could, judjed by the investigator, be confounding the study results (e.g. systemic eritematosus lupus, rheumatoid arthritis, inflammatory bowel disease);

11.Patients showing low compliance to the study procedures, patients with difficult venous access, and all those patients who are judged (by the investigator) to be inadequate for this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified