申请企业

Kamada Ltd.

药品名称

Glassia, Alpha-1-Proteinase Inhibitor (Human)

状态

延迟

承诺描述

Conduct a study exploring potential adverse events associated with protein aggregates. This study will evaluate the safety of the product following multiple repeat exposures over a period of at least 6 months of regular weekly administration. It will include design features that will permit the detection of potential adverse events (AEs) due to the presence of protein aggregates in the product. The study will also include viral nucleic acid testing (NAT) and testing for anti-Alpha1-PI antibodies using an appropriately validated assay. The study will also explore epithelial lining fluid analytes and potential adverse events associated with immunogenicity, and viral safety following the use of Kamada's Intravenous, Human Alpha1-PI (GLASSIA) and another commercial Alpha1-PI, in Alpha1-Antitrypsin [Alpha1-PI] Deficient Patients.

承诺状态描述

The study completion date has passed and the study has not yet been completed. The final report due date has passed with no final report received.

报告接收日期

2020/9/1 0:00:00

批准日期

2010/7/1 0:00:00

截止日期

2014/3/18 0:00:00

CDER/CBER

CB

子类型标记

F