ID
41367
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 Eligibility Criteria Form has to be filled in at the screening visit. It determines the eligibility of the subject to participate in the study.
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
Eligibility Criteria
- StudyEvent: ODM
Beskrivning
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beskrivning
(dd-mmm-yyyy)
Datatyp
date
Alias
- UMLS CUI [1]
- C1320303
Beskrivning
Gender and age
Datatyp
text
Alias
- UMLS CUI [1]
- C0001779
- UMLS CUI [2]
- C0079399
Beskrivning
Complete appropriate sections on HIT History Form.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0272285
- UMLS CUI [1,2]
- C1301725
- UMLS CUI [2,1]
- C0032181
- UMLS CUI [2,2]
- C0547047
- UMLS CUI [2,3]
- C0332282
- UMLS CUI [2,4]
- C0019134
- UMLS CUI [3,1]
- C0032181
- UMLS CUI [3,2]
- C0547047
- UMLS CUI [3,3]
- C1298908
- UMLS CUI [3,4]
- C0681841
- UMLS CUI [3,5]
- C1523987
Beskrivning
Anticoagulation required | positive HIT test | current thrombocytopenia absent
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0003281
- UMLS CUI [1,2]
- C1514873
- UMLS CUI [2,1]
- C1319556
- UMLS CUI [2,2]
- C1514241
- UMLS CUI [3,1]
- C0040034
- UMLS CUI [3,2]
- C0521116
- UMLS CUI [3,3]
- C0332197
Beskrivning
Alternative anticoagulation required | suspected diagnosis of HIT | previous heparin exposure | absence of current platelet count | absence of HIT antibody data
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0003281
- UMLS CUI [1,2]
- C1523987
- UMLS CUI [1,3]
- C1514873
- UMLS CUI [2,1]
- C0272285
- UMLS CUI [2,2]
- C0332147
- UMLS CUI [3,1]
- C0019134
- UMLS CUI [3,2]
- C0205156
- UMLS CUI [3,3]
- C0332157
- UMLS CUI [4,1]
- C0032181
- UMLS CUI [4,2]
- C0521116
- UMLS CUI [4,3]
- C0332197
- UMLS CUI [5,1]
- C1546437
- UMLS CUI [5,2]
- C0744812
Beskrivning
Alternative anticoagulation required | AT-III deficiency | heparin resistance
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0003281
- UMLS CUI [1,2]
- C1523987
- UMLS CUI [1,3]
- C1514873
- UMLS CUI [2]
- C0272375
- UMLS CUI [3]
- C1167838
Beskrivning
Informed consent | Informed assent
Datatyp
text
Alias
- UMLS CUI [1]
- C0021430
- UMLS CUI [2]
- C5205794
Beskrivning
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beskrivning
(dd-mmm-yyyy)
Datatyp
date
Alias
- UMLS CUI [1]
- C1320303
Beskrivning
Argatroban contraincidation | trial participation dangerous to subject due to medical condition
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0048470
- UMLS CUI [1,2]
- C1301624
- UMLS CUI [2,1]
- C3843040
- UMLS CUI [2,2]
- C1444641
- UMLS CUI [2,3]
- C1113679
- UMLS CUI [2,4]
- C2348568
Beskrivning
Unexplained increase of aPPT value | absence of heparin
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0030605
- UMLS CUI [1,2]
- C0205217
- UMLS CUI [1,3]
- C4288071
- UMLS CUI [2,1]
- C0019134
- UMLS CUI [2,2]
- C0332197
Beskrivning
bleeding diathesis
Datatyp
text
Alias
- UMLS CUI [1]
- C0005779
Beskrivning
INR increased | absence of warfarin therapy
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0525032
- UMLS CUI [1,2]
- C0205217
- UMLS CUI [2,1]
- C0043031
- UMLS CUI [2,2]
- C0332197
Beskrivning
Known site of bleeding | bleeding tendency | GI bleeding | hematuria | hemorragic CVA | retroperitoneal hematoma | diabetic retinopathy | hemorrhagic pericardial effusion | hemorrhagic pleural effusion | bleeding risk greater than thrombosis risk
Datatyp
text
Alias
- UMLS CUI [1]
- C3258161
- UMLS CUI [2]
- C1458140
- UMLS CUI [3]
- C0017181
- UMLS CUI [4]
- C0018965
- UMLS CUI [5]
- C0553692
- UMLS CUI [6]
- C0341512
- UMLS CUI [7]
- C0011884
- UMLS CUI [8]
- C3670880
- UMLS CUI [9]
- C0585110
- UMLS CUI [10,1]
- C3251812
- UMLS CUI [10,2]
- C0439093
- UMLS CUI [10,3]
- C0040053
- UMLS CUI [10,4]
- C0035647
Beskrivning
Recent use of investigational medication | Other investigational drug planned during study period
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013230
- UMLS CUI [1,2]
- C0332185
- UMLS CUI [2,1]
- C0013230
- UMLS CUI [2,2]
- C0205394
- UMLS CUI [2,3]
- C1301732
- UMLS CUI [2,4]
- C0347984
- UMLS CUI [2,5]
- C2347804
Beskrivning
Hypersensitivity to Argatroban
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0048470
- UMLS CUI [1,2]
- C0020517
Beskrivning
Gender | childbearing potential | pregnancy | serum beta-HCG positive | breastfeeding | sexually active, contraception inadequate | IUD | oral contraceptives
Datatyp
text
Alias
- UMLS CUI [1]
- C0079399
- UMLS CUI [2]
- C3831118
- UMLS CUI [3]
- C0032961
- UMLS CUI [4,1]
- C0430060
- UMLS CUI [4,2]
- C1514241
- UMLS CUI [5]
- C0006147
- UMLS CUI [6,1]
- C0241028
- UMLS CUI [6,2]
- C0700589
- UMLS CUI [6,3]
- C0205412
- UMLS CUI [7]
- C0021900
- UMLS CUI [8]
- C0009905
Beskrivning
Thrombolytic medication | tPA
Datatyp
text
Alias
- UMLS CUI [1]
- C0040044
- UMLS CUI [2]
- C0032143
Beskrivning
Neonate | corrected gestational age | bleeding in head on untrasonography
Datatyp
text
Alias
- UMLS CUI [1]
- C0021289
- UMLS CUI [2]
- C3831006
- UMLS CUI [3,1]
- C0018670
- UMLS CUI [3,2]
- C0019080
- UMLS CUI [3,3]
- C0041618
Similar models
Eligibility Criteria
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2])
C1301725 (UMLS CUI [1,2])
C0032181 (UMLS CUI [2,1])
C0547047 (UMLS CUI [2,2])
C0332282 (UMLS CUI [2,3])
C0019134 (UMLS CUI [2,4])
C0032181 (UMLS CUI [3,1])
C0547047 (UMLS CUI [3,2])
C1298908 (UMLS CUI [3,3])
C0681841 (UMLS CUI [3,4])
C1523987 (UMLS CUI [3,5])
C1514873 (UMLS CUI [1,2])
C1319556 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0040034 (UMLS CUI [3,1])
C0521116 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C1523987 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0272285 (UMLS CUI [2,1])
C0332147 (UMLS CUI [2,2])
C0019134 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C0332157 (UMLS CUI [3,3])
C0032181 (UMLS CUI [4,1])
C0521116 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C1546437 (UMLS CUI [5,1])
C0744812 (UMLS CUI [5,2])
C1523987 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0272375 (UMLS CUI [2])
C1167838 (UMLS CUI [3])
C5205794 (UMLS CUI [2])
C1301624 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
C0205217 (UMLS CUI [1,2])
C4288071 (UMLS CUI [1,3])
C0019134 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0205217 (UMLS CUI [1,2])
C0043031 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1458140 (UMLS CUI [2])
C0017181 (UMLS CUI [3])
C0018965 (UMLS CUI [4])
C0553692 (UMLS CUI [5])
C0341512 (UMLS CUI [6])
C0011884 (UMLS CUI [7])
C3670880 (UMLS CUI [8])
C0585110 (UMLS CUI [9])
C3251812 (UMLS CUI [10,1])
C0439093 (UMLS CUI [10,2])
C0040053 (UMLS CUI [10,3])
C0035647 (UMLS CUI [10,4])
C0332185 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
C0347984 (UMLS CUI [2,4])
C2347804 (UMLS CUI [2,5])
C0020517 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
C0430060 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
C0006147 (UMLS CUI [5])
C0241028 (UMLS CUI [6,1])
C0700589 (UMLS CUI [6,2])
C0205412 (UMLS CUI [6,3])
C0021900 (UMLS CUI [7])
C0009905 (UMLS CUI [8])
C0032143 (UMLS CUI [2])
C3831006 (UMLS CUI [2])
C0018670 (UMLS CUI [3,1])
C0019080 (UMLS CUI [3,2])
C0041618 (UMLS CUI [3,3])