ID

4855

Beschreibung

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

Link

http://clinicaltrials.gov/show/NCT00157157

Stichworte

Versionen (4)
  1. 28.11.11 28.11.11 -
  2. 13.04.14 13.04.14 - Julian Varghese
  3. 13.04.21 13.04.21 - Dr. rer. medic Philipp Neuhaus
  4. 20.09.21 20.09.21 -
Hochgeladen am

13. April 2014

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility NCT00157157 Hemophilia

Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Beschreibung

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
Beschreibung

Hemophilia A

Datentyp

boolean

The subject is < 6 years of age
Beschreibung

Age

Datentyp

boolean

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

Informed consent

Datentyp

boolean

Exclusion Criteria
Beschreibung

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
Beschreibung

other factor VIII

Datentyp

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
Beschreibung

previous rAHF PFM

Datentyp

boolean

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

inhibitor to factor VIII

Datentyp

boolean

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

history of inhibitor to factor VIII

Datentyp

boolean

The subject has a known hypersensitivity to rAHF PFM
Beschreibung

Hypersensitivity to rAHF PFM

Datentyp

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
Beschreibung

Lab abnormalities

Datentyp

boolean

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

other hemostatic defect than hemophilia A

Datentyp

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
Beschreibung

HIV, HCV, HBV

Datentyp

boolean

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

significant chronic disease

Datentyp

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
Beschreibung

other trial

Datentyp

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
Beschreibung

non-compliance to study procedures

Datentyp

boolean

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

received blood product

Datentyp

boolean

Medical concepts
Beschreibung

Medical concepts

Diagnosis
Beschreibung

Diagnosis

Datentyp

string

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

Factor VIII deficiency

Datentyp

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
Beschreibung

Coagulation factor VIII activity actual/Normal

Datentyp

string

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

Age

Datentyp

string

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

Informed Consent

Datentyp

string

Alias
UMLS CUI
C0021430
Medication
Beschreibung

Pharmaceutical Preparations

Datentyp

string

Alias
UMLS CUI
C0013227
Factor VIII
Beschreibung

Factor VIII

Datentyp

string

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

Factor VIII inhibitor screening test

Datentyp

string

Alias
UMLS CUI
C1446152
SNOMED CT 2010_0731
413021006
Hypersensitivity
Beschreibung

Allergy

Datentyp

string

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

Platelet count

Datentyp

string

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

Hemoglobin

Datentyp

string

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

Creatinine

Datentyp

string

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

Bilirubin

Datentyp

string

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

Coagulation Factor Deficiency

Datentyp

string

Alias
UMLS CUI
C0849773
SNOMED CT 2010_0731
86075001
MedDRA 13.1
10067787
ICD-9-CM Version 2011
286
HIV negative
Beschreibung

HIV negative

Datentyp

string

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

Hepatitis B or C

Datentyp

string

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

Enrollment

Datentyp

string

Alias
UMLS CUI
C2348568
Compliance
Beschreibung

Compliance

Datentyp

string

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

Blood product

Datentyp

string

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

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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)
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