A Study to Investigate Bio Product Laboratory Ltd (BPL's) Factor X in

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Summary

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).

NCT number	NCT01721681
Study type	Interventional
Source	Bio Products Laboratory
Contact
Status	Completed
Phase	Phase 3
Start date	April 2015
Completion date	October 2016

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	`NCT00930176` - A Study Investigating Treatment Factor X in People With Factor X Deficiency	Phase 3

A Study to Investigate Bio Product Laboratory Ltd (BPL's) Factor X in the Prophylaxis of Bleeding in Children <12 Years

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms