Elstree, Herts. UKIn recent years, several purified factor IX concentrates have been produced with a much higher specific activity for factor IX activity than prothrombin concentrate complexes (PCCs). As a result of additional purification steps, these new concentrates are essentially free of other clotting factors [l-61. The rationale that led to the development of these products has been the hypothesis that the presence of clotting factors other than factor IX contributes to the risk of thrombogenicity previously associated with the use of PCCs [7-lo]. Recent experience with purified factor IX concentrates, both in animals and man, suggests that they may prove to be less thrombogenic than PCCs [4,11-141.The prothrombin concentrate complex produced for many years by the Bio Products Laboratory, Elstree (BPL), has a specific activity of 2.0-3.0 idmg. This product, known as 9A, has an excellent record for haemostatic efficacy, but as with other PCCs there have been occasional reports of thromboembolic complications [ 151. Accordingly, a new purified factor IX concentrate was developed by BPL that was essentially free of other clotting factors (see page 12). Following demonstrations in vitro and in animal studies that it was likely to be less thrombogenic than PCCs (see page 16), studies were carried out in man to establish the pharmacokinetic profile of the new product.
Phamacokinetic studies in patients with haemophilia BA cross-over study was carried out on 19 patients with haemophilia B given on different occasions, a conventional three-factor PCC (9A) and the new high-purity factor IX (Replenine) developed by BPL [16]. Both preparations were given intravenously with at least a 7-day period between the infusions, Factor IX levels were measured pre-infusion, and at 10 and 30 min, 1, 3,6, 9,24, 30,46 and 50 h postinfusion. Sixteen severe (