| DEC-NET Serial number ES435 |
| |
| Published online | 28/06/2005 17.06.00 |
| Last updated | 24/04/2006 8.42.44 |
| |
| Other protocol ID number | KG0201 |
| Current trial status | Closed to recruitment of participants: follow-up continuing |
Major Disease
(ICD9 class) | CONGENITAL FACTOR VIII DISORDER (haemophilia) |
| Experimental drug |
COAGULATION FACTOR VIII
Treatment regimen (dosage and duration)
N/A |
| Gender | Male |
| Age (range) | 6-39 years old |
Eligibility criteria |
| Inclusion criteria |
| Patients with hemophilia A (basal level C, with factor VIII < 2%) treated with Kogenate Bayer as the only source of recombinant factor VIII. |
| Exclusion criteria |
| Those listed in the labeling: known hypersensitivity to the active substance or excipients. |
Trial design/methodology |
| Phase | 4 |
| Kind of study | Efficacy
Safety
|
| Design | Observacional prospectivo. |
| Purpose of study |
| To assess the long-term safety, efficacy and tolerability of Kogenate given prophylactically or on demand, as required. |
| Primary outcomes |
| Adverse reactions
Efficacy
Tolerability
Acceptance by the patient.
|
| Secondary outcomes |
| Clinical history related to hemophilia
Infusions of factor VIII
Concentration of factor VIII and inhibitor antibody
Surgical interventions
Adverse reactions
Follow-up of the serologies for hepatitis A,B,C and HIV.
|
| Summary of study design, objectives, and ongoing research findings |
| This is an observational prospective study. If the patient were not included in the study the regimen of treatment and observations (visits...) would be the same. |
