drugset / Trial / NCT00621673

Assessment of the Risk of Inhibitor Formation in Previously Treated Patients With Severe Hemophilia A

NCT00621673

Phase 4 Terminated 1 enrolled Bayer
Non-randomizedSingle-groupOpen-labelSupportive care

Summary

Most transient inhibitor formation, if any, will develop within the first 4 weeks. The study is to further monitor whether participants with severe Hemophilia A will develop inhibitors or antibodies at the later stage when switched from their current recombinant therapy produced from Chinese Hamster Ovary (CHO) cell line to Kogenate-FS raised in a Baby Hamster Kidney cell line.

Timeline

Start
2006-05
Primary completion
Completion
2006-10

Drugs

EvaluationDrugModalityDoseRoute
Subject ADVATE Protein / enzyme biologic 20 iu/kg
Subject ADVATE Protein / enzyme biologic 40 iu/kg

Indications