Eligibility NCT00157157 Hemophilia
ODM derived from http://clinicaltrials.gov/show/NCT00157157

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
Hemophilia A
Item
The subject has severe or moderately severe hemophilia A as defined by a baseline factor VIII level <= 2% of normal, as documented at screening
boolean
Age
Item
The subject is < 6 years of age
boolean
Informed consent
Item
The subject's legally authorized representative has provided written informed consent
boolean
Item Group
Exclusion Criteria
other factor VIII
Item
The subject has a history of exposure to factor VIII other than rAHF PFM or more than 3 infusions of commercially available rAHF PFM (i.e., ADVATE) within 28 days prior to screening, as determined by the subject's medical history. Any infusion of factor VIII replacement products prior to the 28-day period excludes the subject from participation
boolean
previous rAHF PFM
Item
The subject has received more than 3 infusions of rAHF PFM (commercially available and/or study product) between screening and prior to the initial recovery infusion
boolean
inhibitor to factor VIII
Item
The subject has a detectable inhibitor to factor VIII, as measured in the screening sample by the Nijmegen assay in the central laboratory
boolean
history of inhibitor to factor VIII
Item
The subject has a history of inhibitor to factor VIII at any time prior to screening
boolean
Hypersensitivity to rAHF PFM
Item
The subject has a known hypersensitivity to rAHF PFM
boolean
Lab abnormalities
Item
The subject has any 1 of the following laboratory abnormalities at the time of screening: 1) Platelet count < 100,000/mm^3 2) Hemoglobin concentration < 10 g/dL (100 g/L) 3) Serum creatinine > 1.5 times the upper limit of normal (ULN) for age 4) Total bilirubin > 2 times the ULN for age
boolean
other hemostatic defect than hemophilia A
Item
The subject has an inherited or acquired hemostatic defect other than hemophilia A (e.g., qualitative platelet defect or von Willebrand's disease)
boolean
HIV, HCV, HBV
Item
The subject is known to be seropositive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV), as determined by the subject's medical history
boolean
significant chronic disease
Item
At the time of enrollment, the subject has a clinically significant chronic disease other than hemophilia A
boolean
other trial
Item
The subject is currently participating in another investigational drug study, or has participated in any clinical study involving an investigational drug within 120 days of the screening visit
boolean
non-compliance to study procedures
Item
The subject (or the subject's legally authorized representative) is identified by the investigator as being unable or unwilling to cooperate with study procedures
boolean
received blood product
Item
The subject has received any blood product, including packed red blood cells (RBC), platelets, plasma, or cryoprecipitate
boolean
Item Group
Medical concepts
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Factor VIII deficiency
Item
Hemophilia A
string
C0019069 (UMLS CUI)
234440005 (SNOMED CT 2010_0731)
10016080 (MedDRA 13.1)
D66 (ICD-10-CM Version 2010)
286.0 (ICD-9-CM Version 2011)
Coagulation factor VIII activity actual/Normal
Item
Factor VIII Measurement
string
C2825857 (UMLS CUI)
3209-4 (LOINC Version 232)
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Informed Consent
Item
Informed Consent
string
C0021430 (UMLS CUI)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
Factor VIII
Item
Factor VIII
string
C0015506 (UMLS CUI)
278910002 (SNOMED CT 2010_0731)
MTHU009422 (LOINC Version 232)
Factor VIII inhibitor screening test
Item
Factor VIII inhibitor screening test
string
C1446152 (UMLS CUI)
413021006 (SNOMED CT 2010_0731)
Allergy
Item
Hypersensitivity
string
C0020517 (UMLS CUI)
257550005 (SNOMED CT 2010_0731)
T78.40 (ICD-10-CM Version 2010)
Platelet count
Item
Platelet count - finding
string
C1287267 (UMLS CUI)
365632008 (SNOMED CT 2010_0731)
777-3 (LOINC Version 232)
Hemoglobin
Item
Hemoglobin
string
C0518015 (UMLS CUI)
38082009 (SNOMED CT 2010_0731)
10019481 (MedDRA 13.1)
LP14449-0 (LOINC Version 232)
Creatinine
Item
Creatinine
string
C0201976 (UMLS CUI)
15373003 (SNOMED CT 2010_0731)
10011358 (MedDRA 13.1)
38483-4 (LOINC Version 232)
Bilirubin
Item
Bilirubin
string
C0011221 (UMLS CUI)
79706000 (SNOMED CT 2010_0731)
1975-2 (LOINC Version 232)
Coagulation Factor Deficiency
Item
Coagulation Factor Deficiency
string
C0849773 (UMLS CUI)
86075001 (SNOMED CT 2010_0731)
10067787 (MedDRA 13.1)
286 (ICD-9-CM Version 2011)
HIV negative
Item
HIV negative
string
C0481430 (UMLS CUI)
143223008 (SNOMED CT 2010_0731)
10020179 (MedDRA 13.1)
Hepatitis B or C
Item
Hepatitis B, C
string
C0019163 (UMLS CUI-1)
C0019196 (UMLS CUI-2)
Enrollment
Item
Enrollment
string
C2348568 (UMLS CUI)
Compliance
Item
Compliance
string
C1321605 (UMLS CUI)
405078008 (SNOMED CT 2010_0731)
Blood product
Item
Blood product
string
C0456388 (UMLS CUI)
410652009 (SNOMED CT 2010_0731)
BLDPRD (HL7 V3 02-34)