ID

43510

Description

ODM derived from http://clinicaltrials.gov/show/NCT00927667

Link

http://clinicaltrials.gov/show/NCT00927667

Keywords

Versions (3)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/17/14 4/17/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00927667 Hemophilia A

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 12 Years to 35 Years
Description

age 12 Years to 35 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
male, male gender
Description

Males aged 12 - 35 years

Data type

boolean

Alias
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
Severe hemophilia A ( < 1 % FVIII:C)
Description

Severe hemophilia A ( < 1 % FVIII:C)

Data type

boolean

Alias
UMLS CUI 2011AA
C0272322
No history of Factor VIII inhibitory antibody
Description

No history of Factor VIII inhibitory antibody

Data type

boolean

Alias
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0368953
SNOMED CT 2011_0131
58730008
LOINC Version 232
MTHU014157
For prophylaxis groups, having received at least two prophylactic infusions per week for 45 weeks per year for the prevention of bleeding without relevant interruption and continuing until the present.
Description

For prophylaxis groups, having received at least two prophylactic infusions per week for 45 weeks per year for the prevention of bleeding without relevant interruption and continuing until the present.

Data type

boolean

Alias
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0199176
SNOMED CT 2011_0131
360271000
MedDRA 14.1
10036898
UMLS CUI 2011AA
C0574032
SNOMED CT 2011_0131
36576007
MedDRA 14.1
10060345
HL7 V3 2006_05
_Infusion
UMLS CUI 2011AA
C2700409
UMLS CUI 2011AA
C0019080
SNOMED CT 2011_0131
50960005
MedDRA 14.1
10055798
ICD-10-CM Version 2010
R58
ICD-9-CM Version 2011
459.0
Complete documentation of joints bleeds and their locations prior to start of prophylaxis,
Description

Complete documentation of joints bleeds and their locations prior to start of prophylaxis,

Data type

boolean

Alias
UMLS CUI 2011AA
C0920316
UMLS CUI 2011AA
C0018924
SNOMED CT 2011_0131
81808003
MedDRA 14.1
10018829
ICD-10-CM Version 2010
M25.0
ICD-9-CM Version 2011
719.1
UMLS CUI 2011AA
C0450429
SNOMED CT 2011_0131
246267002
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0199176
SNOMED CT 2011_0131
360271000
MedDRA 14.1
10036898
Bleeding history and/or treatments received during the last 5 years documented in the subjects medical records.
Description

Bleeding history and/or treatments received during the last 5 years documented in the subjects medical records.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0019080
SNOMED CT 2011_0131
50960005
MedDRA 14.1
10055798
ICD-10-CM Version 2010
R58
ICD-9-CM Version 2011
459.0
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C0205451
SNOMED CT 2011_0131
34001005
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
For the on-demand subjects > 12 bleeds/year in the last 5 years.
Description

For the on-demand subjects > 12 bleeds/year in the last 5 years.

Data type

boolean

Alias
UMLS CUI 2011AA
C0679686
UMLS CUI 2011AA
C0439093
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
UMLS CUI 2011AA
C0205458
SNOMED CT 2011_0131
82809009
UMLS CUI 2011AA
C1970394
UMLS CUI 2011AA
C0439508
SNOMED CT 2011_0131
259039008
Written informed consent by subject and parent/legal representative, if < 18 years
Description

Written informed consent by subject and parent/legal representative, if < 18 years

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Individuals with other coagulopathies (e.g., von Willebrand disease)
Description

Individuals with other coagulopathies (e.g., von Willebrand disease)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0005779
SNOMED CT 2011_0131
64779008
MedDRA 14.1
10009802
ICD-10-CM Version 2010
D68.9
UMLS CUI 2011AA
C0042974
SNOMED CT 2011_0131
128105004
MedDRA 14.1
10047715
ICD-10-CM Version 2010
D68.0
ICD-9-CM Version 2011
286.4
HIV Seropositivity
Description

HIV seropositive subjects

Data type

boolean

Alias
UMLS CUI 2011AA
C0019699
SNOMED CT 2011_0131
165816005
MedDRA 14.1
10020188
ICD-10-CM Version 2010
Z21
Individuals for whom the most clinically severe joint is not one of the 4 index joints (ankle, knee)
Description

Individuals for whom the most clinically severe joint is not one of the 4 index joints (ankle, knee)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0022417
SNOMED CT 2011_0131
39352004
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0003086
SNOMED CT 2011_0131
344001
UMLS CUI 2011AA
C0022742
SNOMED CT 2011_0131
304679005
LOINC Version 232
MTHU002687
HCV seropositive individuals who underwent interferon therapy during the last 12 months
Description

HCV seropositive individuals who underwent interferon therapy during the last 12 months

Data type

boolean

Alias
UMLS CUI 2011AA
C0220847
SNOMED CT 2011_0131
62944002
MedDRA 14.1
10019752
UMLS CUI 2011AA
C0521143
SNOMED CT 2011_0131
4879001
UMLS CUI 2011AA
C0279030
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
Arthroplasty, Replacement
Description

Joint replacement

Data type

boolean

Alias
UMLS CUI 2011AA
C0185317
SNOMED CT 2011_0131
61557004
MedDRA 14.1
10023227
For the on-demand treatment group, any period > 8 consecutive months having received >/= 50 IU per kg per week Factor VIII for the prevention of bleeding
Description

For the on-demand treatment group, any period > 8 consecutive months having received >/= 50 IU per kg per week Factor VIII for the prevention of bleeding

Data type

boolean

Alias
UMLS CUI 2011AA
C0679686
UMLS CUI 2011AA
C1948053
UMLS CUI 2011AA
C0439093
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
UMLS CUI 2011AA
C0205454
SNOMED CT 2011_0131
7319005
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0015506
SNOMED CT 2011_0131
278910002, 259736008
LOINC Version 232
MTHU009422
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age 12 Years to 35 Years
Item
age 12 Years to 35 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Males aged 12 - 35 years
Item
male, male gender
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
Severe hemophilia A ( < 1 % FVIII:C)
Item
Severe hemophilia A ( < 1 % FVIII:C)
boolean
C0272322 (UMLS CUI 2011AA)
No history of Factor VIII inhibitory antibody
Item
No history of Factor VIII inhibitory antibody
boolean
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0368953 (UMLS CUI 2011AA)
58730008 (SNOMED CT 2011_0131)
MTHU014157 (LOINC Version 232)
For prophylaxis groups, having received at least two prophylactic infusions per week for 45 weeks per year for the prevention of bleeding without relevant interruption and continuing until the present.
Item
For prophylaxis groups, having received at least two prophylactic infusions per week for 45 weeks per year for the prevention of bleeding without relevant interruption and continuing until the present.
boolean
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0199176 (UMLS CUI 2011AA)
360271000 (SNOMED CT 2011_0131)
10036898 (MedDRA 14.1)
C0574032 (UMLS CUI 2011AA)
36576007 (SNOMED CT 2011_0131)
10060345 (MedDRA 14.1)
_Infusion (HL7 V3 2006_05)
C2700409 (UMLS CUI 2011AA)
C0019080 (UMLS CUI 2011AA)
50960005 (SNOMED CT 2011_0131)
10055798 (MedDRA 14.1)
R58 (ICD-10-CM Version 2010)
459.0 (ICD-9-CM Version 2011)
Complete documentation of joints bleeds and their locations prior to start of prophylaxis,
Item
Complete documentation of joints bleeds and their locations prior to start of prophylaxis,
boolean
C0920316 (UMLS CUI 2011AA)
C0018924 (UMLS CUI 2011AA)
81808003 (SNOMED CT 2011_0131)
10018829 (MedDRA 14.1)
M25.0 (ICD-10-CM Version 2010)
719.1 (ICD-9-CM Version 2011)
C0450429 (UMLS CUI 2011AA)
246267002 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0199176 (UMLS CUI 2011AA)
360271000 (SNOMED CT 2011_0131)
10036898 (MedDRA 14.1)
Bleeding history and/or treatments received during the last 5 years documented in the subjects medical records.
Item
Bleeding history and/or treatments received during the last 5 years documented in the subjects medical records.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0019080 (UMLS CUI 2011AA)
50960005 (SNOMED CT 2011_0131)
10055798 (MedDRA 14.1)
R58 (ICD-10-CM Version 2010)
459.0 (ICD-9-CM Version 2011)
C0039798 (UMLS CUI 2011AA)
C1517741 (UMLS CUI 2011AA)
C0205451 (UMLS CUI 2011AA)
34001005 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
For the on-demand subjects > 12 bleeds/year in the last 5 years.
Item
For the on-demand subjects > 12 bleeds/year in the last 5 years.
boolean
C0679686 (UMLS CUI 2011AA)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205458 (UMLS CUI 2011AA)
82809009 (SNOMED CT 2011_0131)
C1970394 (UMLS CUI 2011AA)
C0439508 (UMLS CUI 2011AA)
259039008 (SNOMED CT 2011_0131)
Written informed consent by subject and parent/legal representative, if < 18 years
Item
Written informed consent by subject and parent/legal representative, if < 18 years
boolean
C0021430 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Individuals with other coagulopathies (e.g., von Willebrand disease)
Item
Individuals with other coagulopathies (e.g., von Willebrand disease)
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0005779 (UMLS CUI 2011AA)
64779008 (SNOMED CT 2011_0131)
10009802 (MedDRA 14.1)
D68.9 (ICD-10-CM Version 2010)
C0042974 (UMLS CUI 2011AA)
128105004 (SNOMED CT 2011_0131)
10047715 (MedDRA 14.1)
D68.0 (ICD-10-CM Version 2010)
286.4 (ICD-9-CM Version 2011)
HIV seropositive subjects
Item
HIV Seropositivity
boolean
C0019699 (UMLS CUI 2011AA)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
Individuals for whom the most clinically severe joint is not one of the 4 index joints (ankle, knee)
Item
Individuals for whom the most clinically severe joint is not one of the 4 index joints (ankle, knee)
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0022417 (UMLS CUI 2011AA)
39352004 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0003086 (UMLS CUI 2011AA)
344001 (SNOMED CT 2011_0131)
C0022742 (UMLS CUI 2011AA)
304679005 (SNOMED CT 2011_0131)
MTHU002687 (LOINC Version 232)
HCV seropositive individuals who underwent interferon therapy during the last 12 months
Item
HCV seropositive individuals who underwent interferon therapy during the last 12 months
boolean
C0220847 (UMLS CUI 2011AA)
62944002 (SNOMED CT 2011_0131)
10019752 (MedDRA 14.1)
C0521143 (UMLS CUI 2011AA)
4879001 (SNOMED CT 2011_0131)
C0279030 (UMLS CUI 2011AA)
C1517741 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
Joint replacement
Item
Arthroplasty, Replacement
boolean
C0185317 (UMLS CUI 2011AA)
61557004 (SNOMED CT 2011_0131)
10023227 (MedDRA 14.1)
For the on-demand treatment group, any period > 8 consecutive months having received >/= 50 IU per kg per week Factor VIII for the prevention of bleeding
Item
For the on-demand treatment group, any period > 8 consecutive months having received >/= 50 IU per kg per week Factor VIII for the prevention of bleeding
boolean
C0679686 (UMLS CUI 2011AA)
C1948053 (UMLS CUI 2011AA)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205454 (UMLS CUI 2011AA)
7319005 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C1514756 (UMLS CUI 2011AA)
C0015506 (UMLS CUI 2011AA)
278910002, 259736008 (SNOMED CT 2011_0131)
MTHU009422 (LOINC Version 232)
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