Factor VII deficiency Haematological Disorders Other specified coagulation defects
Conditions
Interventions
1. Ten severe factor VII patients will be treated with two factor VII containing products in a time frame of at least six weeks
2. Five patients will be treated with a single intravenous injection of
Sponsors
Radboud University Nijmegen Medical Center (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Factor VII clotting activity of less than 5% 2. Age 18 years or older 3. Wash-out period of pdFVII or rFVII(a) of at least 3 days 4. Male or female 5. The intention to participate in a cross-over design (treated-twice)
Exclusion criteria
Exclusion criteria: 1. Age 1 mmol/l (64.5 g/l), trauma or surgery in the last 6 weeks 4. Fever (> 38 degrees centigrade) 5. Clinical indication of liver cirrhosis (echographic indication, enlarged spleen, enlarged liver, decreased platelet count) 6. Hepatitis C recently treated with interferon (wash-out 6 months) 7. Human immunodeficiency virus (HIV) positive 8. Pregnancy 9. Medication: 9.1. Non-steroid anti-inflammatory drugs (NSAIDs) 9.2. Clopidogrel 9.3. Antimicrobial medication 9.4. Thyroid inhibitors 9.5. Serotonin-specific reuptake inhibitor (SSRI?s) 9.6. Hb levels < 7.5 mmol/l for women, < 8.4 mmol/l for men
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic and pharmacodynamic analysis of recombinant activated factor VII and plasma-derived factor VII | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
Italy, Netherlands, Norway
Outcome results
None listed