Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

The subject has severe or moderately severe hemophilia A as defined by a baseline factor VIII level <= 2% of normal, as documented at screening
Description

Hemophilia A

Data type

boolean

The subject is < 6 years of age
Description

Age

Data type

boolean

The subject's legally authorized representative has provided written informed consent
Description

Informed consent

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

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
Description

other factor VIII

Data type

boolean

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
Description

previous rAHF PFM

Data type

boolean

The subject has a detectable inhibitor to factor VIII, as measured in the screening sample by the Nijmegen assay in the central laboratory
Description

inhibitor to factor VIII

Data type

boolean

The subject has a history of inhibitor to factor VIII at any time prior to screening
Description

history of inhibitor to factor VIII

Data type

boolean

The subject has a known hypersensitivity to rAHF PFM
Description

Hypersensitivity to rAHF PFM

Data type

boolean

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
Description

Lab abnormalities

Data type

boolean

The subject has an inherited or acquired hemostatic defect other than hemophilia A (e.g., qualitative platelet defect or von Willebrand's disease)
Description

other hemostatic defect than hemophilia A

Data type

boolean

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
Description

HIV, HCV, HBV

Data type

boolean

At the time of enrollment, the subject has a clinically significant chronic disease other than hemophilia A
Description

significant chronic disease

Data type

boolean

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
Description

other trial

Data type

boolean

The subject (or the subject's legally authorized representative) is identified by the investigator as being unable or unwilling to cooperate with study procedures
Description

non-compliance to study procedures

Data type

boolean

The subject has received any blood product, including packed red blood cells (RBC), platelets, plasma, or cryoprecipitate
Description

received blood product

Data type

boolean

Medical concepts
Description

Medical concepts

Diagnosis
Description

Diagnosis

Data type

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Hemophilia A
Description

Factor VIII deficiency

Data type

string

Alias
UMLS CUI
C0019069
SNOMED CT 2010_0731
234440005
MedDRA 13.1
10016080
ICD-10-CM Version 2010
D66
ICD-9-CM Version 2011
286.0
Factor VIII Measurement
Description

Coagulation factor VIII activity actual/Normal

Data type

string

Alias
UMLS CUI
C2825857
LOINC Version 232
3209-4
Age
Description

Age

Data type

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Informed Consent
Description

Informed Consent

Data type

string

Alias
UMLS CUI
C0021430
Medication
Description

Pharmaceutical Preparations

Data type

string

Alias
UMLS CUI
C0013227
Factor VIII
Description

Factor VIII

Data type

string

Alias
UMLS CUI
C0015506
SNOMED CT 2010_0731
278910002
LOINC Version 232
MTHU009422
Factor VIII inhibitor screening test
Description

Factor VIII inhibitor screening test

Data type

string

Alias
UMLS CUI
C1446152
SNOMED CT 2010_0731
413021006
Hypersensitivity
Description

Allergy

Data type

string

Alias
UMLS CUI
C0020517
SNOMED CT 2010_0731
257550005
ICD-10-CM Version 2010
T78.40
Platelet count - finding
Description

Platelet count

Data type

string

Alias
UMLS CUI
C1287267
SNOMED CT 2010_0731
365632008
LOINC Version 232
777-3
Hemoglobin
Description

Hemoglobin

Data type

string

Alias
UMLS CUI
C0518015
SNOMED CT 2010_0731
38082009
MedDRA 13.1
10019481
LOINC Version 232
LP14449-0
Creatinine
Description

Creatinine

Data type

string

Alias
UMLS CUI
C0201976
SNOMED CT 2010_0731
15373003
MedDRA 13.1
10011358
LOINC Version 232
38483-4
Bilirubin
Description

Bilirubin

Data type

string

Alias
UMLS CUI
C0011221
SNOMED CT 2010_0731
79706000
LOINC Version 232
1975-2
Coagulation Factor Deficiency
Description

Coagulation Factor Deficiency

Data type

string

Alias
UMLS CUI
C0272315
SNOMED CT 2010_0731
86075001
MedDRA 13.1
10067787
ICD-9-CM Version 2011
286
HIV negative
Description

HIV negative

Data type

string

Alias
UMLS CUI
C0481430
SNOMED CT 2010_0731
143223008
MedDRA 13.1
10020179
Hepatitis B, C
Description

Hepatitis B or C

Data type

string

Alias
UMLS CUI-1
C0019163
UMLS CUI-2
C0019196
Enrollment
Description

Enrollment

Data type

string

Alias
UMLS CUI
C2348568
Compliance
Description

Compliance

Data type

string

Alias
UMLS CUI
C1321605
SNOMED CT 2010_0731
405078008
Blood product
Description

Blood product

Data type

string

Alias
UMLS CUI
C0456388
SNOMED CT 2010_0731
410652009
HL7 V3 02-34
BLDPRD

Similar models

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
C0272315 (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)