ID
43091
Description
ODM derived from http://clinicaltrials.gov/show/NCT01376908
Lien
http://clinicaltrials.gov/show/NCT01376908
Mots-clés
Versions (3)
- 17/04/2013 17/04/2013 - Martin Dugas
- 20/04/2014 20/04/2014 - Julian Varghese
- 20/09/2021 20/09/2021 -
Téléchargé le
20 septembre 2021
DOI
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Licence
Creative Commons BY 4.0
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Eligibility NCT01376908 Phenylketonuria (PKU)
Eligibility
- StudyEvent: Eligibility
Description
Ausschlusskriterien
Description
Use of Kuvan, Biopten, or any unregistered preparation of tetrahydrobiopterin within the previous 30 days, unless for the purposes of a BH4 responsiveness test.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C1995652
- SNOMED CT 2011_0131
- 434239009
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- C1514821
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C0048897
- SNOMED CT 2011_0131
- 432859002
- LOINC Version 232
- MTHU035851
- UMLS CUI 2011AA
- C1554961
- HL7 V3 2006_05
- E
- UMLS CUI 2011AA
- C0048897
- SNOMED CT 2011_0131
- 432859002
- LOINC Version 232
- MTHU035851
- UMLS CUI 2011AA
- C0552602
- LOINC Version 232
- MTHU002705
- UMLS CUI 2011AA
- C0022885
- SNOMED CT 2011_0131
- 15220000
- MedDRA 14.1
- 10059938
Description
Previous exposure to Kuvan, Biopten, or any unregistered preparation of tetrahydrobiopterin for >30 days.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0205156
- SNOMED CT 2011_0131
- 9130008
- UMLS CUI 2011AA
- C0332157
- SNOMED CT 2011_0131
- 24932003
- UMLS CUI 2011AA
- C1995652
- SNOMED CT 2011_0131
- 434239009
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- C1514821
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C0048897
- SNOMED CT 2011_0131
- 432859002
- LOINC Version 232
- MTHU035851
- UMLS CUI 2011AA
- C0439093
- SNOMED CT 2011_0131
- 276140008
- HL7 V3 2006_05
- GT
- UMLS CUI 2011AA
- C0205447
- SNOMED CT 2011_0131
- 38112003
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- HL7 V3 2006_05
- MO
Description
Known hypersensitivity to Kuvan or its excipients.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 418634005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C1995652
- SNOMED CT 2011_0131
- 434239009
- UMLS CUI 2011AA
- C0015237
- SNOMED CT 2011_0131
- 360215002
Description
Known hypersensitivity to other approved or non-approved formulations of tetrahydrobiopterin.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 418634005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C1705957
- UMLS CUI 2011AA
- C0048897
- SNOMED CT 2011_0131
- 432859002
- LOINC Version 232
- MTHU035851
Description
Previous diagnosis of BH4 deficiency.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0332132
- SNOMED CT 2011_0131
- 48318009
- UMLS CUI 2011AA
- C0751436
- MedDRA 14.1
- 10069116
Description
Current use of methotrexate, trimethoprim, or other dihydrofolate reductase inhibitors.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0025677
- SNOMED CT 2011_0131
- 387381009
- LOINC Version 232
- MTHU005020
- UMLS CUI 2011AA
- C0041041
- SNOMED CT 2011_0131
- 32792001
- LOINC Version 232
- MTHU002305
- UMLS CUI 2011AA
- C2911817
Description
Current use of medications that are known to affect nitric oxide synthesis, metabolism or action.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C0392760
- SNOMED CT 2011_0131
- 247591002
- UMLS CUI 2011AA
- C1157570
- UMLS CUI 2011AA
- C1158468
Description
Current use of levodopa.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0699991
- SNOMED CT 2011_0131
- 15383004
- LOINC Version 232
- MTHU015998
Description
Current use of experimental/other investigational or unregistered drugs that may affect the study outcomes.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0013230
- UMLS CUI 2011AA
- CL415205
- UMLS CUI 2011AA
- C0392760
- SNOMED CT 2011_0131
- 247591002
- UMLS CUI 2011AA
- C0683954
Description
Inability to comply with study procedures.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C1321605
- SNOMED CT 2011_0131
- 371151008
Description
Inability to tolerate oral intake.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C1299582
- SNOMED CT 2011_0131
- 371151008
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C1527415
- SNOMED CT 2011_0131
- 26643006
- HL7 V3 2006_05
- _OralRoute
- UMLS CUI 2011AA
- C1512806
Description
History of organ transplantation.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0029216
- MedDRA 14.1
- 10061890
- LOINC Version 232
- MTHU000173
Description
Concurrent disease or condition that would interfere with study participation or increase the risk for adverse events, including seizure disorders, corticosteroid administration, active malignancy, diabetes mellitus, severe congenital heart disease, renal or hepatic failure.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0012634
- SNOMED CT 2011_0131
- 64572001
- UMLS CUI 2011AA
- C0348080
- SNOMED CT 2011_0131
- 260905004
- HL7 V3 2006_05
- COND
- UMLS CUI 2011AA
- C0521102
- SNOMED CT 2011_0131
- 78235001
- UMLS CUI 2011AA
- C2348568
- UMLS CUI 2011AA
- C0205217
- HL7 V3 2006_05
- U
- UMLS CUI 2011AA
- C1281905
- UMLS CUI 2011AA
- C0014544
- SNOMED CT 2011_0131
- 84757009, 313307000
- MedDRA 14.1
- 10015037
- LOINC Version 232
- MTHU020586
- ICD-10-CM Version 2010
- G40.9
- ICD-9-CM Version 2011
- 345.9
- UMLS CUI 2011AA
- C0001617
- SNOMED CT 2011_0131
- 79440004
- UMLS CUI 2011AA
- C1533734
- SNOMED CT 2011_0131
- 416118004
- UMLS CUI 2011AA
- C0006826
- SNOMED CT 2011_0131
- 363346000
- MedDRA 14.1
- 10028997
- LOINC Version 232
- MTHU010328
- ICD-10-CM Version 2010
- C00-C96
- UMLS CUI 2011AA
- C0011849
- SNOMED CT 2011_0131
- 191044006
- UMLS CUI 2011AA
- C0152021
- SNOMED CT 2011_0131
- 13213009
- MedDRA 14.1
- 10019273
- ICD-10-CM Version 2010
- Q24.9
- UMLS CUI 2011AA
- C1565489
- MedDRA 14.1
- 10038474
- UMLS CUI 2011AA
- C0085605
- SNOMED CT 2011_0131
- 59927004
- MedDRA 14.1
- 10019663
- ICD-10-CM Version 2010
- K72.9
- CTCAE 1105E
- E11211
Description
Other significant disease that in the Investigator's opinion would exclude the subject from the trial.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0750502
- SNOMED CT 2011_0131
- 386134007
- UMLS CUI 2011AA
- C0012634
- SNOMED CT 2011_0131
- 64572001
- UMLS CUI 2011AA
- C0332196
- SNOMED CT 2011_0131
- 77765009
- UMLS CUI 2011AA
- C0681850
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
Description
Any condition that, in the view of the Principal Investigator renders the subject at high risk for failure to comply with treatment or to complete the study.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0348080
- SNOMED CT 2011_0131
- 260905004
- HL7 V3 2006_05
- COND
- UMLS CUI 2011AA
- C1882509
- UMLS CUI 2011AA
- C0681850
- UMLS CUI 2011AA
- C0332167
- SNOMED CT 2011_0131
- 15508007
- UMLS CUI 2011AA
- C0457432
- SNOMED CT 2011_0131
- 258143003
- UMLS CUI 2011AA
- C0680095
- UMLS CUI 2011AA
- C1554962
- HL7 V3 2006_05
- C
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
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Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
248153007 (SNOMED CT 2011_0131)
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C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
260370003 (SNOMED CT 2011_0131)
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C0428204 (UMLS CUI 2011AA)
365727002 (SNOMED CT 2011_0131)
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276625007 (SNOMED CT 2011_0131)
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C0013220 (UMLS CUI 2011AA)
228432001 (SNOMED CT 2011_0131)
10052804 (MedDRA 14.1)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0031485 (UMLS CUI 2011AA)
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365727002 (SNOMED CT 2011_0131)
C0332285 (UMLS CUI 2011AA)
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C0039798 (UMLS CUI 2011AA)
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41829006 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0184704 (UMLS CUI 2011AA)
55149002 (SNOMED CT 2011_0131)
260676000 (SNOMED CT 2011_0131)
C1995652 (UMLS CUI 2011AA)
434239009 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C1514821 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C0048897 (UMLS CUI 2011AA)
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MTHU035851 (LOINC Version 232)
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9130008 (SNOMED CT 2011_0131)
C0332157 (UMLS CUI 2011AA)
24932003 (SNOMED CT 2011_0131)
C1995652 (UMLS CUI 2011AA)
434239009 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C1514821 (UMLS CUI 2011AA)
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C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C1995652 (UMLS CUI 2011AA)
434239009 (SNOMED CT 2011_0131)
C0015237 (UMLS CUI 2011AA)
360215002 (SNOMED CT 2011_0131)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C1705957 (UMLS CUI 2011AA)
C0048897 (UMLS CUI 2011AA)
432859002 (SNOMED CT 2011_0131)
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10069116 (MedDRA 14.1)
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260676000 (SNOMED CT 2011_0131)
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C0683954 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
371151008 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
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MTHU000173 (LOINC Version 232)
64572001 (SNOMED CT 2011_0131)
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260905004 (SNOMED CT 2011_0131)
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C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C2348568 (UMLS CUI 2011AA)
C0205217 (UMLS CUI 2011AA)
U (HL7 V3 2006_05)
C1281905 (UMLS CUI 2011AA)
C0014544 (UMLS CUI 2011AA)
84757009, 313307000 (SNOMED CT 2011_0131)
10015037 (MedDRA 14.1)
MTHU020586 (LOINC Version 232)
G40.9 (ICD-10-CM Version 2010)
345.9 (ICD-9-CM Version 2011)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C1533734 (UMLS CUI 2011AA)
416118004 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
C0152021 (UMLS CUI 2011AA)
13213009 (SNOMED CT 2011_0131)
10019273 (MedDRA 14.1)
Q24.9 (ICD-10-CM Version 2010)
C1565489 (UMLS CUI 2011AA)
10038474 (MedDRA 14.1)
C0085605 (UMLS CUI 2011AA)
59927004 (SNOMED CT 2011_0131)
10019663 (MedDRA 14.1)
K72.9 (ICD-10-CM Version 2010)
E11211 (CTCAE 1105E)
386134007 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0332196 (UMLS CUI 2011AA)
77765009 (SNOMED CT 2011_0131)
C0681850 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C1882509 (UMLS CUI 2011AA)
C0681850 (UMLS CUI 2011AA)
C0332167 (UMLS CUI 2011AA)
15508007 (SNOMED CT 2011_0131)
C0457432 (UMLS CUI 2011AA)
258143003 (SNOMED CT 2011_0131)
C0680095 (UMLS CUI 2011AA)
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)