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A Study Investigating Treatment Factor X in People With Factor X Deficiency

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ClinicalTrials.gov Identifier: NCT00930176
Recruitment Status : Completed
First Posted : June 30, 2009
Results First Posted : December 12, 2014
Last Update Posted : December 12, 2014
Sponsor:
Information provided by (Responsible Party):
Bio Products Laboratory

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Factor X Deficiency
Intervention Biological: Human Coagulation FACTOR X
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Human Coagulation FACTOR X
Hide Arm/Group Description Human Coagulation FACTOR X: Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
Period Title: Overall Study
Started 16
Completed 15
Not Completed 1
Reason Not Completed
Death             1
Arm/Group Title Human Coagulation FACTOR X
Hide Arm/Group Description Human Coagulation FACTOR X: Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
<=18 years
6
  37.5%
Between 18 and 65 years
10
  62.5%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
10
  62.5%
Male
6
  37.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants
United States 2
Spain 4
Turkey 6
Germany 1
United Kingdom 3
1.Primary Outcome
Title FX:C Incremental Recovery
Hide Description

Incremental recovery is defined as the peak rise in plasma FX levels (IU/dL), as measured at 15, 30 and 60 minutes post-dose, divided by the dose (IU/kg).

Value given is the mean of 31 results: 16 for Baseline Visit + 15 for Repeat PK assessment

Time Frame At Baseline (during first 60 minutes post-dose) and at 6 months post-Baseline (during first 60 minutes post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Coagulation FACTOR X
Hide Arm/Group Description:
Human Coagulation FACTOR X: Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
Overall Number of Participants Analyzed 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: IU/dL per IU/kg
2.07
(21.01%)
2.Primary Outcome
Title FX:C Half-life
Hide Description Value given is the mean of 31 results: 16 for Baseline Visit + 15 for Repeat PK assessment
Time Frame At Baseline and at 6 months post-Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Coagulation FACTOR X
Hide Arm/Group Description:
Human Coagulation FACTOR X: Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
Overall Number of Participants Analyzed 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
29.36
(22.89%)
Time Frame From signing of informed consent form until 28 days post-last dose.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Human Coagulation FACTOR X
Hide Arm/Group Description Human Coagulation FACTOR X: Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
All-Cause Mortality
Human Coagulation FACTOR X
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Human Coagulation FACTOR X
Affected / at Risk (%) # Events
Total   6/16 (37.50%)    
Blood and lymphatic system disorders   
Anaemia * 1  2/16 (12.50%)  4
Gastrointestinal disorders   
Gastritis * 1  1/16 (6.25%)  1
Infections and infestations   
Pneumonia * 1  1/16 (6.25%)  1
Nosocomial infection * 1  1/16 (6.25%)  1
Tooth abscess * 1  1/16 (6.25%)  1
Gastric ulcer helicobacter * 1  1/16 (6.25%)  1
Injury, poisoning and procedural complications   
Post procedural haemorrhage * 1  1/16 (6.25%)  1
Musculoskeletal and connective tissue disorders   
Back pain * 1  1/16 (6.25%)  1
Muscle haemorrhage * 1  1/16 (6.25%)  1
Nervous system disorders   
Syncope * 1  1/16 (6.25%)  1
Reproductive system and breast disorders   
Dysmenorrhoea * 1  1/16 (6.25%)  1
Menorrhagia * 1  1/16 (6.25%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Human Coagulation FACTOR X
Affected / at Risk (%) # Events
Total   15/16 (93.75%)    
Blood and lymphatic system disorders   
Anaemia * 1  2/16 (12.50%)  4
Iron deficiency anaemia * 1  1/16 (6.25%)  1
Gastrointestinal disorders   
Abdominal pain upper * 1  1/16 (6.25%)  1
Constipation * 1  1/16 (6.25%)  2
Diarrhoea * 1  1/16 (6.25%)  1
Gastrooesophageal reflux disease * 1  2/16 (12.50%)  2
Gingivitis * 1  1/16 (6.25%)  1
Nausea * 1  2/16 (12.50%)  6
Odynophagia * 1  1/16 (6.25%)  3
Toothache * 1  1/16 (6.25%)  1
Vomiting * 1  2/16 (12.50%)  2
General disorders   
Fatigue * 1  1/16 (6.25%)  2
Infusion site erytema * 1  1/16 (6.25%)  2
Infusion site pain * 1  1/16 (6.25%)  1
Malaise * 1  1/16 (6.25%)  2
Non-cardiac chest pain * 1  1/16 (6.25%)  1
Oedema peripheral * 1  1/16 (6.25%)  2
Pyrexia * 1  1/16 (6.25%)  2
Swelling * 1  1/16 (6.25%)  1
Ulcer * 1  2/16 (12.50%)  2
Vessel puncture site haematoma * 1  1/16 (6.25%)  1
Immune system disorders   
Urticaria * 1  1/16 (6.25%)  2
Infections and infestations   
Bronchitis * 1  1/16 (6.25%)  1
Cystitis * 1  2/16 (12.50%)  2
Fungal infection * 1  1/16 (6.25%)  1
Nasopharyngitis * 1  7/16 (43.75%)  11
Oral infection * 1  1/16 (6.25%)  1
Osteomyelitis * 1  1/16 (6.25%)  1
Otitis media * 1  2/16 (12.50%)  2
Respiratory tract infection * 1  1/16 (6.25%)  1
Tooth infection * 1  1/16 (6.25%)  1
Upper respiratory tract infection * 1  4/16 (25.00%)  9
Urinary tract infection * 1  1/16 (6.25%)  1
Injury, poisoning and procedural complications   
Contusion * 1  1/16 (6.25%)  2
Fall * 1  1/16 (6.25%)  1
Head injury * 1  1/16 (6.25%)  1
Joint injury * 1  2/16 (12.50%)  2
Thermal burn * 1  1/16 (6.25%)  1
Metabolism and nutrition disorders   
Fluid overload * 1  1/16 (6.25%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  5/16 (31.25%)  14
Back pain * 1  6/16 (37.50%)  10
Groin pain * 1  1/16 (6.25%)  1
Joint stiffness * 1  1/16 (6.25%)  1
Muscle spasms * 1  2/16 (12.50%)  2
Musculoskeletal pain * 1  3/16 (18.75%)  3
Musculoskeletal stiffness * 1  1/16 (6.25%)  1
Myalgia * 1  2/16 (12.50%)  2
Neck pain * 1  1/16 (6.25%)  4
Osteoarthritis * 1  1/16 (6.25%)  1
Pain in extremity * 1  6/16 (37.50%)  8
Nervous system disorders   
Dizziness * 1  1/16 (6.25%)  1
Headache * 1  8/16 (50.00%)  14
Migraine * 1  1/16 (6.25%)  2
Psychiatric disorders   
Insomnia * 1  1/16 (6.25%)  1
Renal and urinary disorders   
Nephrolithiasis * 1  1/16 (6.25%)  1
Respiratory, thoracic and mediastinal disorders   
Cough * 1  1/16 (6.25%)  1
Dyspnoea * 1  1/16 (6.25%)  1
Nasal congestion * 1  1/16 (6.25%)  1
Oropharyngeal pain * 1  1/16 (6.25%)  1
Tachypnoea * 1  1/16 (6.25%)  1
Skin and subcutaneous tissue disorders   
Acne * 1  1/16 (6.25%)  2
Dermatitis allergic * 1  1/16 (6.25%)  1
Pruritis * 1  1/16 (6.25%)  1
Vascular disorders   
Haematoma * 1  1/16 (6.25%)  2
Hypotension * 1  4/16 (25.00%)  4
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Head of Medical Affairs
Organization: Bio Products Laboratory
Phone: +44 20 8957 2200
Responsible Party: Bio Products Laboratory
ClinicalTrials.gov Identifier: NCT00930176     History of Changes
Other Study ID Numbers: Ten01
First Submitted: June 10, 2009
First Posted: June 30, 2009
Results First Submitted: November 25, 2014
Results First Posted: December 12, 2014
Last Update Posted: December 12, 2014