References

References

1. ClinicalTrials.gov (2014) Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of a Recombinant FVIII in Patients With Severe Hemophilia A [Online] Available at http://clinicaltrials.gov/show/NCT00989196 (Accessed 13 October 2014).

2. Valentino L.A. et al. (2014) 'The first recombinant FVIII produced in human cells - an update on its clinical development programme', Haemophilia, vol. 20 (Suppl. 1), pp. 1-9.

3. EU Clinical Trials Register (2014) Prospective clinical study in children with severe haemophilia A to investigate clinical efficacy, immunogenicity, pharmacokinetics, and safety of human-cl rh FVIII [Online] Available at https://www.clinicaltrialsregister.eu/ctr-search/trial/2010-018644-14/GB (Accessed 13 October 2014).

4. ClinicalTrials.gov (2014) Efficacy and Safety Study of Human-cl rhFVIII in PTPs With Severe Hemophilia A [Online] Available at http://clinicaltrials.gov/show/NCT01125813 (Accessed 13 October 2014).

5. International Standard Randomised Controlled Trial Number Register (2014) Clinical study to investigate the pharmacokinetics, efficacy, safety and immunogenicity of human-cl rhFVIII in previously treated patients with severe haemophilia A [Online] Available at http://www.controlled-trials.com/ISRCTN87293301 (Accessed 13 October 2014).

6. ClinicalTrials.gov (2014) Human-cl-rhFVIII in Previously Untreated Patients [Online] Available at http://clinicaltrials.gov/show/NCT01712438 (Accessed 13 October 2014).

7. Summary of Product Characteristics for Nuwiq® available at https://www.medicines.org.uk/emc/medicine/29373.

8. Casademunt E. et al. (2012) ‘The first recombinant human coagulation factor VIII of human origin: human cell line and manufacturing characteristics’, European Journal of Haematology, vol. 89(2), pp. 165-76.

9. Sandberg H. et al. (2013) ‘Functional characteristics of the novel, human-derived recombinant FVIII protein product, human-cl rhFVIII’, Thrombosis Research, vol. 130, pp. 808-17.

10. EU Clinical Trials Register (2014) Prospective, open-label, multicentre phase 3b study to assess the efficacy and safety of individually tailored prophylaxis with Human-cl rhFVIII in previously treated adult patients with severe haemophilia A [Online] Available at https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-001556-35/GB (Accessed 13 October 2014).

11. http://www.ema.europa.eu/ema/

12. Kannicht C. Ramström M, Kohla G et al. (2013). Characterisation of the post-translational modifications of a novel, human cell line-derived recombinant human factor VIII. Thromb Res; 131:78-88.

13. Shen BW, Spiegel PC, Chang CH, et al. (2008). The tertiary structure and domain organization of coagulation factor VIII. Blood; 111: 1240-1247.

14. Sadler JE (1998). Biochemistry and genetics of von Willebrand factor. Annu Rev Biochem; 67:395-424.

15. Tiede A. et al. (2014). Personalized prophylaxis with human-cl rhFVIII in adult patients with severe haemophilia A. Poster presented at the Bari International Conference, Bari, Italy, 3-5 October 2014.