ID

43091

Description

ODM derived from http://clinicaltrials.gov/show/NCT01376908

Link

http://clinicaltrials.gov/show/NCT01376908

Keywords

Versions (3)
  1. 4/17/13 4/17/13 - Martin Dugas
  2. 4/20/14 4/20/14 - 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 NCT01376908 Phenylketonuria (PKU)

German English

Eligibility

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

Inclusion Criteria

age up to 4 Years
Description

age up to 4 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Male or female PKU infants and young children <4 years of age at the scheduled Day 1 visit of the 26-week Study Period (taking into consideration the maximum of 21 days in the Screening Period).
Description

Male or female PKU infants and young children <4 years of age at the scheduled Day 1 visit of the 26-week Study Period (taking into consideration the maximum of 21 days in the Screening Period).

Data type

boolean

Alias
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0031485
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0021270
SNOMED CT 2011_0131
133931009
MedDRA 14.1
10021731
UMLS CUI 2011AA
C0008059
SNOMED CT 2011_0131
67822003
HL7 V3 2006_05
CHILD
Confirmed clinical and biochemical PKU, including at least two previous blood Phe levels ≥ 400 micromol/L obtained on 2 separate occasions.
Description

Confirmed clinical and biochemical PKU, including at least two previous blood Phe levels ≥ 400 micromol/L obtained on 2 separate occasions.

Data type

boolean

Alias
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0205474
SNOMED CT 2011_0131
80534008
UMLS CUI 2011AA
C0031485
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0005768
UMLS CUI 2011AA
C0428204
SNOMED CT 2011_0131
365727002
Previously responded, as assessed by the Investigator, to a BH4 test, if all 3 of the following criteria are satisfied:
Description

Previously responded, as assessed by the Investigator, to a BH4 test, if all 3 of the following criteria are satisfied:

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0871261
UMLS CUI 2011AA
C0048897
SNOMED CT 2011_0131
432859002
LOINC Version 232
MTHU035851
UMLS CUI 2011AA
C0022885
SNOMED CT 2011_0131
15220000
MedDRA 14.1
10059938
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C1550543
HL7 V3 2006_05
FLFS
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
CL414621
The BH4 dose was 20 mg/kg/day.
Description

The BH4 dose was 20 mg/kg/day.

Data type

boolean

Alias
UMLS CUI 2011AA
C0048897
SNOMED CT 2011_0131
432859002
LOINC Version 232
MTHU035851
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
The duration of the test was at least for 24 hours.
Description

The duration of the test was at least for 24 hours.

Data type

boolean

Alias
UMLS CUI 2011AA
C0429930
SNOMED CT 2011_0131
252129004
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
A 30% decrease in blood Phe levels.
Description

A 30% decrease in blood Phe levels.

Data type

boolean

Alias
UMLS CUI 2011AA
C0547047
SNOMED CT 2011_0131
260370003
UMLS CUI 2011AA
C0005768
UMLS CUI 2011AA
C0428204
SNOMED CT 2011_0131
365727002
Defined level of dietary Phe tolerance consistent with the diagnosis of PKU;
Description

Defined level of dietary Phe tolerance consistent with the diagnosis of PKU;

Data type

boolean

Alias
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C0456079
SNOMED CT 2011_0131
276625007
UMLS CUI 2011AA
C0012155
SNOMED CT 2011_0131
41829006
UMLS CUI 2011AA
C0031453
SNOMED CT 2011_0131
63004003
LOINC Version 232
MTHU003552
UMLS CUI 2011AA
C0013220
SNOMED CT 2011_0131
228432001
MedDRA 14.1
10052804
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0031485
Good adherence to dietary treatment, including prescribed dietary Phe restriction and prescribed amounts of Phe-free protein supplements and low-Phe foods.
Description

Good adherence to dietary treatment, including prescribed dietary Phe restriction and prescribed amounts of Phe-free protein supplements and low-Phe foods.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205170
SNOMED CT 2011_0131
20572008
UMLS CUI 2011AA
C0012155
SNOMED CT 2011_0131
41829006
UMLS CUI 2011AA
C1171369
UMLS CUI 2011AA
C0457976
SNOMED CT 2011_0131
182927005
UMLS CUI 2011AA
C0770246
SNOMED CT 2011_0131
226282004
Maintenance of blood Phe levels within the therapeutic target range of 120-360 micromol/L (defined as ≥120 to < 360 micromol/L) over a 1-month period prior to Screening, as assessed by the Investigator.
Description

Maintenance of blood Phe levels within the therapeutic target range of 120-360 micromol/L (defined as ≥120 to < 360 micromol/L) over a 1-month period prior to Screening, as assessed by the Investigator.

Data type

boolean

Alias
UMLS CUI 2011AA
C0024501
UMLS CUI 2011AA
C0005768
UMLS CUI 2011AA
C0428204
SNOMED CT 2011_0131
365727002
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1521840
UMLS CUI 2011AA
C1514721
Parent(s) and/or guardian(s) willing to comply with all study procedures, maintain strict adherence to the diet, and willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to any study procedures.
Description

Parent(s) and/or guardian(s) willing to comply with all study procedures, maintain strict adherence to the diet, and willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to any study procedures.

Data type

boolean

Alias
UMLS CUI 2011AA
C0030551
SNOMED CT 2011_0131
40683002
HL7 V3 2006_05
PARNT
UMLS CUI 2011AA
C1274041
SNOMED CT 2011_0131
394619001
LOINC Version 232
MTHU014954
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C0525058
UMLS CUI 2011AA
C0012155
SNOMED CT 2011_0131
41829006
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0184704
SNOMED CT 2011_0131
55149002
Exclusion Criteria
Description

Exclusion Criteria

Use of Kuvan, Biopten, or any unregistered preparation of tetrahydrobiopterin within the previous 30 days, unless for the purposes of a BH4 responsiveness test.
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.

Data type

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
Previous exposure to Kuvan, Biopten, or any unregistered preparation of tetrahydrobiopterin for >30 days.
Description

Previous exposure to Kuvan, Biopten, or any unregistered preparation of tetrahydrobiopterin for >30 days.

Data type

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
Known hypersensitivity to Kuvan or its excipients.
Description

Known hypersensitivity to Kuvan or its excipients.

Data type

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
Known hypersensitivity to other approved or non-approved formulations of tetrahydrobiopterin.
Description

Known hypersensitivity to other approved or non-approved formulations of tetrahydrobiopterin.

Data type

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
Previous diagnosis of BH4 deficiency.
Description

Previous diagnosis of BH4 deficiency.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332132
SNOMED CT 2011_0131
48318009
UMLS CUI 2011AA
C0751436
MedDRA 14.1
10069116
Current use of methotrexate, trimethoprim, or other dihydrofolate reductase inhibitors.
Description

Current use of methotrexate, trimethoprim, or other dihydrofolate reductase inhibitors.

Data type

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
Current use of medications that are known to affect nitric oxide synthesis, metabolism or action.
Description

Current use of medications that are known to affect nitric oxide synthesis, metabolism or action.

Data type

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
Current use of levodopa.
Description

Current use of levodopa.

Data type

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0699991
SNOMED CT 2011_0131
15383004
LOINC Version 232
MTHU015998
Current use of experimental/other investigational or unregistered drugs that may affect the study outcomes.
Description

Current use of experimental/other investigational or unregistered drugs that may affect the study outcomes.

Data type

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
Inability to comply with study procedures.
Description

Inability to comply with study procedures.

Data type

boolean

Alias
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
371151008
Inability to tolerate oral intake.
Description

Inability to tolerate oral intake.

Data type

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
History of organ transplantation.
Description

History of organ transplantation.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0029216
MedDRA 14.1
10061890
LOINC Version 232
MTHU000173
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.
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.

Data type

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
Other significant disease that in the Investigator's opinion would exclude the subject from the trial.
Description

Other significant disease that in the Investigator's opinion would exclude the subject from the trial.

Data type

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
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.
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.

Data type

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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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
age up to 4 Years
Item
age up to 4 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Male or female PKU infants and young children <4 years of age at the scheduled Day 1 visit of the 26-week Study Period (taking into consideration the maximum of 21 days in the Screening Period).
Item
Male or female PKU infants and young children <4 years of age at the scheduled Day 1 visit of the 26-week Study Period (taking into consideration the maximum of 21 days in the Screening Period).
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0031485 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0021270 (UMLS CUI 2011AA)
133931009 (SNOMED CT 2011_0131)
10021731 (MedDRA 14.1)
C0008059 (UMLS CUI 2011AA)
67822003 (SNOMED CT 2011_0131)
CHILD (HL7 V3 2006_05)
Confirmed clinical and biochemical PKU, including at least two previous blood Phe levels ≥ 400 micromol/L obtained on 2 separate occasions.
Item
Confirmed clinical and biochemical PKU, including at least two previous blood Phe levels ≥ 400 micromol/L obtained on 2 separate occasions.
boolean
C0750484 (UMLS CUI 2011AA)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0205474 (UMLS CUI 2011AA)
80534008 (SNOMED CT 2011_0131)
C0031485 (UMLS CUI 2011AA)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0005768 (UMLS CUI 2011AA)
C0428204 (UMLS CUI 2011AA)
365727002 (SNOMED CT 2011_0131)
Previously responded, as assessed by the Investigator, to a BH4 test, if all 3 of the following criteria are satisfied:
Item
Previously responded, as assessed by the Investigator, to a BH4 test, if all 3 of the following criteria are satisfied:
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0871261 (UMLS CUI 2011AA)
C0048897 (UMLS CUI 2011AA)
432859002 (SNOMED CT 2011_0131)
MTHU035851 (LOINC Version 232)
C0022885 (UMLS CUI 2011AA)
15220000 (SNOMED CT 2011_0131)
10059938 (MedDRA 14.1)
C0750557 (UMLS CUI 2011AA)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
The BH4 dose was 20 mg/kg/day.
Item
The BH4 dose was 20 mg/kg/day.
boolean
C0048897 (UMLS CUI 2011AA)
432859002 (SNOMED CT 2011_0131)
MTHU035851 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
The duration of the test was at least for 24 hours.
Item
The duration of the test was at least for 24 hours.
boolean
C0429930 (UMLS CUI 2011AA)
252129004 (SNOMED CT 2011_0131)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
A 30% decrease in blood Phe levels.
Item
A 30% decrease in blood Phe levels.
boolean
C0547047 (UMLS CUI 2011AA)
260370003 (SNOMED CT 2011_0131)
C0005768 (UMLS CUI 2011AA)
C0428204 (UMLS CUI 2011AA)
365727002 (SNOMED CT 2011_0131)
Defined level of dietary Phe tolerance consistent with the diagnosis of PKU;
Item
Defined level of dietary Phe tolerance consistent with the diagnosis of PKU;
boolean
C1704788 (UMLS CUI 2011AA)
C0456079 (UMLS CUI 2011AA)
276625007 (SNOMED CT 2011_0131)
C0012155 (UMLS CUI 2011AA)
41829006 (SNOMED CT 2011_0131)
C0031453 (UMLS CUI 2011AA)
63004003 (SNOMED CT 2011_0131)
MTHU003552 (LOINC Version 232)
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)
Good adherence to dietary treatment, including prescribed dietary Phe restriction and prescribed amounts of Phe-free protein supplements and low-Phe foods.
Item
Good adherence to dietary treatment, including prescribed dietary Phe restriction and prescribed amounts of Phe-free protein supplements and low-Phe foods.
boolean
C0205170 (UMLS CUI 2011AA)
20572008 (SNOMED CT 2011_0131)
C0012155 (UMLS CUI 2011AA)
41829006 (SNOMED CT 2011_0131)
C1171369 (UMLS CUI 2011AA)
C0457976 (UMLS CUI 2011AA)
182927005 (SNOMED CT 2011_0131)
C0770246 (UMLS CUI 2011AA)
226282004 (SNOMED CT 2011_0131)
Maintenance of blood Phe levels within the therapeutic target range of 120-360 micromol/L (defined as ≥120 to < 360 micromol/L) over a 1-month period prior to Screening, as assessed by the Investigator.
Item
Maintenance of blood Phe levels within the therapeutic target range of 120-360 micromol/L (defined as ≥120 to < 360 micromol/L) over a 1-month period prior to Screening, as assessed by the Investigator.
boolean
C0024501 (UMLS CUI 2011AA)
C0005768 (UMLS CUI 2011AA)
C0428204 (UMLS CUI 2011AA)
365727002 (SNOMED CT 2011_0131)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C1521840 (UMLS CUI 2011AA)
C1514721 (UMLS CUI 2011AA)
Parent(s) and/or guardian(s) willing to comply with all study procedures, maintain strict adherence to the diet, and willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to any study procedures.
Item
Parent(s) and/or guardian(s) willing to comply with all study procedures, maintain strict adherence to the diet, and willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to any study procedures.
boolean
C0030551 (UMLS CUI 2011AA)
40683002 (SNOMED CT 2011_0131)
PARNT (HL7 V3 2006_05)
C1274041 (UMLS CUI 2011AA)
394619001 (SNOMED CT 2011_0131)
MTHU014954 (LOINC Version 232)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0525058 (UMLS CUI 2011AA)
C0012155 (UMLS CUI 2011AA)
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)
Item Group
Exclusion Criteria
Use of Kuvan, Biopten, or any unregistered preparation of tetrahydrobiopterin within the previous 30 days, unless for the purposes of a BH4 responsiveness test.
Item
Use of Kuvan, Biopten, or any unregistered preparation of tetrahydrobiopterin within the previous 30 days, unless for the purposes of a BH4 responsiveness test.
boolean
C1524063 (UMLS CUI 2011AA)
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)
432859002 (SNOMED CT 2011_0131)
MTHU035851 (LOINC Version 232)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0048897 (UMLS CUI 2011AA)
432859002 (SNOMED CT 2011_0131)
MTHU035851 (LOINC Version 232)
C0552602 (UMLS CUI 2011AA)
MTHU002705 (LOINC Version 232)
C0022885 (UMLS CUI 2011AA)
15220000 (SNOMED CT 2011_0131)
10059938 (MedDRA 14.1)
Previous exposure to Kuvan, Biopten, or any unregistered preparation of tetrahydrobiopterin for >30 days.
Item
Previous exposure to Kuvan, Biopten, or any unregistered preparation of tetrahydrobiopterin for >30 days.
boolean
C0205156 (UMLS CUI 2011AA)
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)
C0013227 (UMLS CUI 2011AA)
C0048897 (UMLS CUI 2011AA)
432859002 (SNOMED CT 2011_0131)
MTHU035851 (LOINC Version 232)
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)
Known hypersensitivity to Kuvan or its excipients.
Item
Known hypersensitivity to Kuvan or its excipients.
boolean
C0020517 (UMLS CUI 2011AA)
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)
Known hypersensitivity to other approved or non-approved formulations of tetrahydrobiopterin.
Item
Known hypersensitivity to other approved or non-approved formulations of tetrahydrobiopterin.
boolean
C0020517 (UMLS CUI 2011AA)
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)
MTHU035851 (LOINC Version 232)
Previous diagnosis of BH4 deficiency.
Item
Previous diagnosis of BH4 deficiency.
boolean
C0332132 (UMLS CUI 2011AA)
48318009 (SNOMED CT 2011_0131)
C0751436 (UMLS CUI 2011AA)
10069116 (MedDRA 14.1)
Current use of methotrexate, trimethoprim, or other dihydrofolate reductase inhibitors.
Item
Current use of methotrexate, trimethoprim, or other dihydrofolate reductase inhibitors.
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0025677 (UMLS CUI 2011AA)
387381009 (SNOMED CT 2011_0131)
MTHU005020 (LOINC Version 232)
C0041041 (UMLS CUI 2011AA)
32792001 (SNOMED CT 2011_0131)
MTHU002305 (LOINC Version 232)
C2911817 (UMLS CUI 2011AA)
Current use of medications that are known to affect nitric oxide synthesis, metabolism or action.
Item
Current use of medications that are known to affect nitric oxide synthesis, metabolism or action.
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0392760 (UMLS CUI 2011AA)
247591002 (SNOMED CT 2011_0131)
C1157570 (UMLS CUI 2011AA)
C1158468 (UMLS CUI 2011AA)
Current use of levodopa.
Item
Current use of levodopa.
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0699991 (UMLS CUI 2011AA)
15383004 (SNOMED CT 2011_0131)
MTHU015998 (LOINC Version 232)
Current use of experimental/other investigational or unregistered drugs that may affect the study outcomes.
Item
Current use of experimental/other investigational or unregistered drugs that may affect the study outcomes.
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
CL415205 (UMLS CUI 2011AA)
C0392760 (UMLS CUI 2011AA)
247591002 (SNOMED CT 2011_0131)
C0683954 (UMLS CUI 2011AA)
Inability to comply with study procedures.
Item
Inability to comply with study procedures.
boolean
C1321605 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
Inability to tolerate oral intake.
Item
Inability to tolerate oral intake.
boolean
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C1512806 (UMLS CUI 2011AA)
History of organ transplantation.
Item
History of organ transplantation.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0029216 (UMLS CUI 2011AA)
10061890 (MedDRA 14.1)
MTHU000173 (LOINC Version 232)
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.
Item
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.
boolean
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
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)
Other significant disease that in the Investigator's opinion would exclude the subject from the trial.
Item
Other significant disease that in the Investigator's opinion would exclude the subject from the trial.
boolean
C0750502 (UMLS CUI 2011AA)
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)
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.
Item
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.
boolean
C0348080 (UMLS CUI 2011AA)
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)
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