drugset / Trial / NCT01051544
Study of First TIME Immunotolerance Induction in Severe Hemophilia A Patients With Inhibitor at High Risk of Failure: Comparison With FVIII Concentrates With or Without Von Willebrand Factor - RES.I.S.T. Naive
Withdrawn
City of Hope Medical Center
Biotest Pharmaceuticals Corporation · collabCSL Behring · collabCharta Foundation · collabGrifols Biologicals, LLC · collabGrifols Therapeutics LLC · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
This is a prospective, controlled, randomized, open label study, aimed at comparing FVIII/VWF concentrates with FVIII concentrates at 200 IU/kg daily in their ability to induce immune tolerance in Haemophilia A patients with high responding inhibitors and poor prognosis for success.
Timeline
- Start
- 2009-09-25
- Primary completion
- 2020-06-25
- Completion
- 2020-06-25
Outcome
Outcome not reported
Stopped: “complete per PI”
Publications
- Background Berntorp E, Ekman M, Gunnarsson M, Nilsson IM. Variation in factor VIII inhibitor reactivity with different commercial factor VIII preparations. Haemophilia. 1996 Apr;2(2):95-9. doi: 10.1111/j.1365-2516.1996.tb00022.x.
- Background Kreutz W: Immune tolerance induction (ITI) in Haemophilia A-patients with inhibitors - the choice of concentrate affecting success. Haematologica2001; 86 (S4):16-20
- Background Gringeri A, Musso R, Mazzucconi MG, Piseddu G, Schiavoni M, Pignoloni P, Mannucci PM; RITS-FITNHES Study Group. Immune tolerance induction with a high purity von Willebrand factor/VIII complex concentrate in haemophilia A patients with inhibitors at high risk of a poor response. Haemophilia. 2007 Jul;13(4):373-9. doi: 10.1111/j.1365-2516.2007.01484.x.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ADVATE | Protein / enzyme biologic | 200 iu/kg | — |
| Comparator | Beriate P | Protein / enzyme biologic | 200 iu/kg | — |
| Comparator | Emoclot DI | Protein / enzyme biologic | 200 iu/kg | Other |
| Comparator | FVIII/VWF concentrates | Protein / enzyme biologic | 200 iu/kg | Other |
| Comparator | Factane | Protein / enzyme biologic | 200 iu/kg | Other |
| Comparator | Fahndi | Protein / enzyme biologic | 200 iu/kg | Other |
| Comparator | Haemoctine SDH | Protein / enzyme biologic | 200 iu/kg | Other |
| Comparator | Helixate | Protein / enzyme biologic | 200 iu/kg | — |
| Comparator | Hemofil M | Protein / enzyme biologic | 200 iu/kg | — |
| Comparator | Koate-DVI | Protein / enzyme biologic | 200 iu/kg | Other |
| Comparator | Kogenate SF | Protein / enzyme biologic | 200 iu/kg | — |
| Comparator | Monarch M | Protein / enzyme biologic | 200 iu/kg | — |
| Comparator | Monoclate | Protein / enzyme biologic | 200 iu/kg | — |
| Comparator | Moroctocog alfa | Protein / enzyme biologic | 200 iu/kg | — |
| Comparator | Optivate | Protein / enzyme biologic | 200 iu/kg | Other |
| Comparator | Replenate | Protein / enzyme biologic | 200 iu/kg | — |
| Comparator | Wilate | Protein / enzyme biologic | 200 iu/kg | Other |