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Clinical Trial Summary

The main objective of the study is to assess the pharmacokinetics of FACTOR X after a single dose of 25IU/kg.

The secondary objectives of the study are to assess efficacy and safety of FACTOR X in the treatment of bleeding episodes over at least 6 months.


Clinical Trial Description

n/a


Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00930176
Study type Interventional
Source Bio Products Laboratory
Contact
Status Completed
Phase Phase 3
Start date January 2010
Completion date November 2013

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT03655223 - Early Check: Expanded Screening in Newborns
Terminated NCT01086852 - Safety & Efficacy of BPL's High Purity FACTOR X in Treatment of Factor X Deficient Subjects Undergoing Surgery Phase 3
Completed NCT01721681 - A Study to Investigate Bio Product Laboratory Ltd (BPL's) Factor X in the Prophylaxis of Bleeding in Children <12 Years Phase 3