ID
41370
Beskrivning
Study ID: 105043/013 Clinical Study ID: 105043/013 Study Title: An Open-Label Study of Argatroban Injection to Evaluate the Safety and Effectiveness in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin (Protocol SKF105043/013) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00039858 Sponsor: GlaxoSmithKline Collaborators: Encysive Pharmaceuticals Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Argatroban Trade Name: N/A Study Indication: Thrombosis This Study evaluates the safety and the efficacy of i.v. Argatroban treatment in paediatric patients which require anticoagulants but aren't suitable for Heparin treatment. The study consists of screening visit (pre-treatment examination), treatment period of maximum 14 days after reaching therapeutical dose, post-treatment visit (once the treatment is stopped or after 14 days) and a follow-up visit which follows 30 days (+/- 14 days) after clinical resolution of underlying condition or after the end of the 14-day study period. Treatment can be continued after the 14-day study period if needed but such treatment isn't part of this Study. See https://clinicaltrials.gov/ct2/show/NCT00039858 The HIT History Form has to be filled in at the screening visit. It is used to record details of prior Heparin Induced Thrombocytopaenia. To be completed within 7 days before treatment initiation.
Länk
https://clinicaltrials.gov/ct2/show/NCT00039858
Nyckelord
Versioner (1)
- 2020-09-14 2020-09-14 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
14 september 2020
DOI
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Licens
Creative Commons BY-NC 4.0
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Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858
HIT History
- StudyEvent: ODM
Beskrivning
If ‘YES’ was answered for Inclusion Criterion 2a, please give details of the HIT diagnosis and heparin exposure as follows:
Alias
- UMLS CUI-1
- C0272285
- UMLS CUI-2
- C0332157
- UMLS CUI-3
- C0019134
Beskrivning
(dd-mmm-yyyy)
Datatyp
date
Alias
- UMLS CUI [1]
- C2316983
Beskrivning
Platelet Count decrease after heparin initiation
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0392386
- UMLS CUI [1,2]
- C0687676
- UMLS CUI [1,3]
- C1704686
- UMLS CUI [1,4]
- C0019134
Beskrivning
Thrombosis associated with HIT
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0040053
- UMLS CUI [1,2]
- C0332281
- UMLS CUI [1,3]
- C0272285
Beskrivning
*If ‘Yes’, indicate test, date completed, and results: (Check all that apply; note enrollment is not contingent on receipt of results. Complete this form when results are available.)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0272285
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0750484
Beskrivning
HPF4 ELISA
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C4512079
- UMLS CUI [1,2]
- C0014441
Beskrivning
(dd-mmm-yyyy)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C4512079
- UMLS CUI [1,2]
- C0014441
- UMLS CUI [1,3]
- C0011008
Beskrivning
HPF4 ELISA Result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C4512079
- UMLS CUI [1,2]
- C0014441
- UMLS CUI [1,3]
- C0456984
Beskrivning
SRA
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3506382
Beskrivning
(dd-mmm-yyyy)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C3506382
- UMLS CUI [1,2]
- C0011008
Beskrivning
SRA Result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3506382
- UMLS CUI [1,2]
- C0456984
Beskrivning
HIPA
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0919798
Beskrivning
(dd-mmm-yyyy)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0919798
- UMLS CUI [1,2]
- C0011008
Beskrivning
HIPA Result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0919798
- UMLS CUI [1,2]
- C0456984
Beskrivning
HIT confirmatory diagnostic test, other
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0272285
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0750484
- UMLS CUI [1,4]
- C0205394
Beskrivning
HIT confirmatory diagnostic test, other, specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0272285
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0750484
- UMLS CUI [1,4]
- C0205394
- UMLS CUI [1,5]
- C1521902
Beskrivning
(dd-mmm-yyyy)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0272285
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0750484
- UMLS CUI [1,4]
- C0205394
- UMLS CUI [1,5]
- C0011008
Beskrivning
HIT confirmatory diagnostic test, other, result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0272285
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0750484
- UMLS CUI [1,4]
- C0205394
- UMLS CUI [1,5]
- C0456984
Beskrivning
If ‘YES’ was answered for Inclusion Criterion 2b, please give details of the most recent positive HIT test history and prior heparin exposure as follows:
Alias
- UMLS CUI-1
- C1513491
- UMLS CUI-2
- C0272285
- UMLS CUI-3
- C0456984
Beskrivning
(dd-mmm-yyyy)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C0272285
- UMLS CUI [1,3]
- C0011008
Beskrivning
Which HIT test was done? (Check all that apply, enter date and results; note enrollment is not contingent on receipt of results.)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C4512079
- UMLS CUI [1,2]
- C0014441
Beskrivning
(dd-mmm-yyyy)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C4512079
- UMLS CUI [1,2]
- C0014441
- UMLS CUI [1,3]
- C0011008
Beskrivning
HPF4 ELISA Result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C4512079
- UMLS CUI [1,2]
- C0014441
- UMLS CUI [1,3]
- C0456984
Beskrivning
SRA
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3506382
Beskrivning
(dd-mmm-yyyy)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C3506382
- UMLS CUI [1,2]
- C0011008
Beskrivning
SRA Result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3506382
- UMLS CUI [1,2]
- C0456984
Beskrivning
HIPA
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0919798
Beskrivning
(dd-mmm-yyyy)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0919798
- UMLS CUI [1,2]
- C0011008
Beskrivning
HIPA Result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0919798
- UMLS CUI [1,2]
- C0456984
Beskrivning
HIT confirmatory diagnostic test, other
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0272285
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0750484
- UMLS CUI [1,4]
- C0205394
Beskrivning
HIT confirmatory diagnostic test, other, specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0272285
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0750484
- UMLS CUI [1,4]
- C0205394
- UMLS CUI [1,5]
- C1521902
Beskrivning
(dd-mmm-yyyy)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0272285
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0750484
- UMLS CUI [1,4]
- C0205394
- UMLS CUI [1,5]
- C0011008
Beskrivning
HIT confirmatory diagnostic test, other, result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0272285
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0750484
- UMLS CUI [1,4]
- C0205394
- UMLS CUI [1,5]
- C0456984
Beskrivning
Platelet Count decrease after heparin initiation
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0392386
- UMLS CUI [1,2]
- C0687676
- UMLS CUI [1,3]
- C1704686
- UMLS CUI [1,4]
- C0019134
Beskrivning
Platelet count drop
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0392386
Beskrivning
Platelet count drop
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0392386
Beskrivning
Platelet count drop
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0392386
Beskrivning
Thrombosis associated with HIT
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0040053
- UMLS CUI [1,2]
- C0332281
- UMLS CUI [1,3]
- C0272285
Beskrivning
Please fill in the Heparin Exposure section unless YES ticked.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0332157
- UMLS CUI [1,2]
- C0019134
- UMLS CUI [1,3]
- C1511726
- UMLS CUI [1,4]
- C0439673
- UMLS CUI [2,1]
- C0332157
- UMLS CUI [2,2]
- C0019134
- UMLS CUI [2,3]
- C1511726
- UMLS CUI [2,4]
- C0686905
Beskrivning
If ‘YES’ was answered for Inclusion Criterion 2c, please provide details of all previous heparin exposure/data:
Alias
- UMLS CUI-1
- C0205156
- UMLS CUI-2
- C0332157
- UMLS CUI-3
- C0019134
- UMLS CUI-4
- C0205197
Beskrivning
Please fill in the Heparin Exposure section unless YES ticked.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0332157
- UMLS CUI [1,2]
- C0019134
- UMLS CUI [1,3]
- C1511726
- UMLS CUI [1,4]
- C0439673
- UMLS CUI [2,1]
- C0332157
- UMLS CUI [2,2]
- C0019134
- UMLS CUI [2,3]
- C1511726
- UMLS CUI [2,4]
- C0686905
Beskrivning
If ‘YES’ was answered for Inclusion Criterion 2d, what was the underlying condition?
Alias
- UMLS CUI-1
- C0272375
- UMLS CUI-2
- C4722602
- UMLS CUI-3
- C0348080
Beskrivning
Underlying condition of antithrombin III deficiency
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0272375
- UMLS CUI [1,2]
- C4722602
- UMLS CUI [1,3]
- C0348080
Beskrivning
Alternative anticoagulation required | Other underlying disease, specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0003281
- UMLS CUI [1,2]
- C1523987
- UMLS CUI [1,3]
- C1514873
- UMLS CUI [2,1]
- C4722602
- UMLS CUI [2,2]
- C0012634
- UMLS CUI [2,3]
- C0205394
- UMLS CUI [2,4]
- C1521902
Beskrivning
Heparin Exposure
Alias
- UMLS CUI-1
- C0332157
- UMLS CUI-2
- C0019134
Beskrivning
Please select to which criterion is the following data related. If one entry is related to multiple criteria, please fill in multiple times to include all of them.
Datatyp
text
Alias
- UMLS CUI [1]
- C1512693
Beskrivning
Type of heparin
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0019134
- UMLS CUI [1,2]
- C0332307
Beskrivning
Types of heparin - Comments
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0019134
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0947611
Beskrivning
(dd-mmm-yyyy)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0019134
- UMLS CUI [1,2]
- C0808070
Beskrivning
(dd-mmm-yyyy)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0019134
- UMLS CUI [1,2]
- C0806020
Beskrivning
Route of heparin admission
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0019134
- UMLS CUI [1,2]
- C0013153
Beskrivning
Route of heparin admission - other, specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0019134
- UMLS CUI [1,2]
- C0013153
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1521902
Similar models
HIT History
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C0332157 (UMLS CUI-2)
C0019134 (UMLS CUI-3)
C0687676 (UMLS CUI [1,2])
C1704686 (UMLS CUI [1,3])
C0019134 (UMLS CUI [1,4])
C0332281 (UMLS CUI [1,2])
C0272285 (UMLS CUI [1,3])
C0430022 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
C0014441 (UMLS CUI [1,2])
C0014441 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0014441 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0430022 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0430022 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C1521902 (UMLS CUI [1,5])
C0430022 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,5])
C0430022 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0456984 (UMLS CUI [1,5])
C0272285 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
C0272285 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0014441 (UMLS CUI [1,2])
C0014441 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0014441 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0430022 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0430022 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C1521902 (UMLS CUI [1,5])
C0430022 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,5])
C0430022 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0456984 (UMLS CUI [1,5])
C0687676 (UMLS CUI [1,2])
C1704686 (UMLS CUI [1,3])
C0019134 (UMLS CUI [1,4])
C0332281 (UMLS CUI [1,2])
C0272285 (UMLS CUI [1,3])
C0019134 (UMLS CUI [1,2])
C1511726 (UMLS CUI [1,3])
C0439673 (UMLS CUI [1,4])
C0332157 (UMLS CUI [2,1])
C0019134 (UMLS CUI [2,2])
C1511726 (UMLS CUI [2,3])
C0686905 (UMLS CUI [2,4])
C0332157 (UMLS CUI-2)
C0019134 (UMLS CUI-3)
C0205197 (UMLS CUI-4)
C0019134 (UMLS CUI [1,2])
C1511726 (UMLS CUI [1,3])
C0439673 (UMLS CUI [1,4])
C0332157 (UMLS CUI [2,1])
C0019134 (UMLS CUI [2,2])
C1511726 (UMLS CUI [2,3])
C0686905 (UMLS CUI [2,4])
C4722602 (UMLS CUI-2)
C0348080 (UMLS CUI-3)
C4722602 (UMLS CUI [1,2])
C0348080 (UMLS CUI [1,3])
C1523987 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C4722602 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C1521902 (UMLS CUI [2,4])
C0332307 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])