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More info
You can access this
clinical trial
if you have
Factor X Deficiency
and you are
under 11
years old
3
This is a trial in the final phase before the treatment is released on the market.
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The purpose

The primary objective of the study is to assess the efficacy of FACTOR X in the prevention of bleeding when given as routine prophylaxis over 12 months. The secondary objectives of the study are: 1. To assess the pharmacokinetics of FACTOR X after a single dose of 50 IU/kg. 2. To assess the safety of FACTOR X when given as routine prophylaxis over 6 months (26 weeks).

Provided treatments

  • Biological: FACTOR X

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01721681. The sponsor of the trial is Bio Products Laboratory and it is looking for 9 volunteers for the current phase.
Official trial title:
A Phase III Open, Multicentre Study to Investigate the Safety, Pharmacokinetics and Efficacy of BPL's High Purity Factor X in the Prophylaxis of Bleeding in Factor X Deficient Children Under the Age of 12 Years