NCT01626105 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Howard TE, Yanover C, Mahlangu J, Krause A, Viel KR, Kasper CK, Pratt KP
Haemophilia management: time to get personal? Haemophilia. 2011 Sep;17(5):721-8. doi: 10.1111/j.1365-2516.2011.02517.x. Epub 2011 Jun 8. Review.
Viel KR, Ameri A, Abshire TC, Iyer RV, Watts RG, Lutcher C, Channell C, Cole SA, Fernstrom KM, Nakaya S, Kasper CK, Thompson AR, Almasy L, Howard TE
Inhibitors of factor VIII in black patients with hemophilia. N Engl J Med. 2009 Apr 16;360(16):1618-27. doi: 10.1056/NEJMoa075760. Erratum in: N Engl J Med. 2009 Jul 30;361(5):544.
Yanover C, Jain N, Pierce G, Howard TE, Sauna ZE
Pharmacogenetics and the immunogenicity of protein therapeutics. Nat Biotechnol. 2011 Oct 13;29(10):870-3. doi: 10.1038/nbt.2002.

Study of Severe Hemophilia A Patients Who Have Only Received a Single Recombinant FVIII Therapeutic for the Purpose of Identifying the Pharmacogenetic Determinants of Tolerance and Immunogenicity

Details for clinical trial NCT01626105

Clinical trial NCT01626105 - References