Clinical trial
An Open-Label, Randomized, Parallel, Multicenter Trial Comparing the Safety and Efficacy of rFVIIa When Administered as i.v. Bolus or i.v. Continuous Infusion to Hemophiliacs With Inhibitors During and After Major Surgery
Name
F7HAEM/USA/4/USA
Description
This trial is conducted in North America. The aim of this trial is to compare the safety and efficacy of activated recombinant human factor VII in patients with haemophilia A or B undergoing major surgical procedures.
Trial arms
Trial start
1998-04-01
Estimated PCD
2004-05-01
Trial end
2004-05-01
Status
Completed
Phase
Early phase I
Treatment
activated recombinant human factor VII
Infused continuously at 50 mcg/kg/hr through Day 5 then at 25 mcg/kg/hr on Days 6 to10.
Arms:
Continuous infusion
activated recombinant human factor VII
Injected every 2 hours during surgery through Day 5, then every 4 hours for Days 6 to 10.
Arms:
Bolus injection
factor IX
Patients with haemophilia A or B without inhibitors undergoing similar surgery were treated in accordance with local standard of care per physician's orders.
Arms:
Control
factor VIII
Patients with haemophilia A or B without inhibitors undergoing similar surgery were treated in accordance with local standard of care per physician's orders.
Arms:
Control
Size
36
Primary endpoint
Presence and maintenance of haemostasis
Changes in FVII:C (Factor VII clotting activity) levels following administration of activated recombinant human factor VII
Eligibility criteria
Inclusion Criteria:
* Have haemophilia A or B with inhibitors to factor VIII or IX, respectively
* Have had a historical inhibitor level of at least five Bethesda units or have had an inadequate haemostatic response to 250 U/kg of factor VIII or IX or have had an inadequate response to FEIBA
* Require pre-planned major surgery in hospital
Exclusion Criteria:
* Have participated in or have been treated with any investigational drug other than activated recombinant human factor VII within the last thirty days
* Have been treated with any haemostatic agent, including rFVIIa, within 48 hours of preoperative dose
* Have any haemostatic disorder other than haemophilia
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 36, 'type': 'ACTUAL'}}
Updated at
2023-12-29
1 organization
Organization
Novo Nordisk