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Register:	EUCTR
Last refreshed on:	31 March 2014
Main ID:	EUCTR2009-011145-18-DE
Date of registration:	01/04/2010
Prospective Registration:	Yes
Primary sponsor:	Bio Products Laboratory Limited
Public title:	A Phase III Open, Multicentre Study to Investigate the Pharmacokinetics, Safety and Efficacy of BPL's High Purity Factor X in the Treatment of Severe and Moderate Factor X Deficiency - A PK study of BPL's FX in patients with FX deficiency
Scientific title:	A Phase III Open, Multicentre Study to Investigate the Pharmacokinetics, Safety and Efficacy of BPL's High Purity Factor X in the Treatment of Severe and Moderate Factor X Deficiency - A PK study of BPL's FX in patients with FX deficiency
Date of first enrolment:	21/09/2010
Target sample size:	16
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-011145-18
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
Phase:

Countries of recruitment
Germany	Spain	United Kingdom

Contacts

Name:
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Affiliation:

Name:
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Key inclusion & exclusion criteria

Inclusion criteria:
Informed consent
At least 12 years of age
With hereditary severe or moderate factor X deficiency (<5% basal activity at diagnosis)
Currently treated with fresh frozen plasma (FFP), prothrombin complex concentrates (PCC) or factor IX/X concentrate
Have had a minimum of one spontaneous or menorrhagic bleed in the last 12 months which required treatment with either FFP, PCC or factor IX/X concentrate
At least 14 days since an infusion of FFP, PCC or factor IX/X concentrate at the Baseline Visit
Female subjects of childbearing potential must not be pregnant at entry to the study and must practice contraception for the duration of the study.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
History of inhibitor development to FX, or a positive inhibitor result at the Screening Visit
Bleeding at the Baseline Visit
Subjects with thrombocytopenia, clinically significant renal disease or clinically significant liver disease
Subjects with other coagulopathy or thrombophilia
Known or suspected hypersensitivity to the investigational medicinal product or its excipients
Known to have abused chemicals or drugs within the past 12 months
History of unreliability or non-cooperation
Participation in another clinical trial within the past 30 days, with the exception of BPL FX surgery study (protocol No Ten03). In such cases, subjects should have completed their End-of-Study Visit either before or on the day of the Screening Visit for this study
Female subjects who are pregnant or lactating.
Subjects who are planning more than 4 weeks absence from the locality of the investigational site, between the Screening Visit and the Repeat PK Assessment.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Factor X deficiency
MedDRA version: 12.1 Level: LLT Classification code 10052474 Term: Factor X deficiency

Intervention(s)

Product Name: Human factor X
Product Code: FACTOR X
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: FACTOR X
Other descriptive name: Human factor X
Concentration unit: IU international unit(s)
Concentration type: range
Concentration number: 400-625

Primary Outcome(s)

Main Objective: To assess the pharmacokinetics of Factor X after a single dose of 25 IU/kg

Secondary Objective: To assess the efficacy of Factor X in the treatment of bleeding episodes over at least 6 months.
To assess the safety of Factor X in the treatment of bleeding episodes over at least 6 months.

Primary end point(s): The PK parameters incremental recovery, half-life (non-compartmental), half-life (two compartmental, if appropriate), AUC (0-144h), AUC (0-infinity), clearance, MRT (0-infinity) volume of distribution, Cmax, Cmax(obs), Tmax and terminal elimination rate constant for FX:C at Baseline Visit and 6 Month Visit.

Secondary Outcome(s)

Secondary ID(s)

2009-011145-18-GB

TEN01

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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