ID
41367
Beschrijving
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.
Link
https://clinicaltrials.gov/ct2/show/NCT00039858
Trefwoorden
Versies (1)
- 14-09-20 14-09-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
14 september 2020
DOI
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Licentie
Creative Commons BY-NC 4.0
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Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858
Eligibility Criteria
- StudyEvent: ODM
Beschrijving
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beschrijving
(dd-mmm-yyyy)
Datatype
date
Alias
- UMLS CUI [1]
- C1320303
Beschrijving
Gender and age
Datatype
text
Alias
- UMLS CUI [1]
- C0001779
- UMLS CUI [2]
- C0079399
Beschrijving
Complete appropriate sections on HIT History Form.
Datatype
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
Beschrijving
Anticoagulation required | positive HIT test | current thrombocytopenia absent
Datatype
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
Beschrijving
Alternative anticoagulation required | suspected diagnosis of HIT | previous heparin exposure | absence of current platelet count | absence of HIT antibody data
Datatype
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
Beschrijving
Alternative anticoagulation required | AT-III deficiency | heparin resistance
Datatype
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
Beschrijving
Informed consent | Informed assent
Datatype
text
Alias
- UMLS CUI [1]
- C0021430
- UMLS CUI [2]
- C5205794
Beschrijving
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beschrijving
(dd-mmm-yyyy)
Datatype
date
Alias
- UMLS CUI [1]
- C1320303
Beschrijving
Argatroban contraincidation | trial participation dangerous to subject due to medical condition
Datatype
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
Beschrijving
Unexplained increase of aPPT value | absence of heparin
Datatype
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
Beschrijving
bleeding diathesis
Datatype
text
Alias
- UMLS CUI [1]
- C0005779
Beschrijving
INR increased | absence of warfarin therapy
Datatype
text
Alias
- UMLS CUI [1,1]
- C0525032
- UMLS CUI [1,2]
- C0205217
- UMLS CUI [2,1]
- C0043031
- UMLS CUI [2,2]
- C0332197
Beschrijving
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
Datatype
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
Beschrijving
Recent use of investigational medication | Other investigational drug planned during study period
Datatype
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
Beschrijving
Hypersensitivity to Argatroban
Datatype
text
Alias
- UMLS CUI [1,1]
- C0048470
- UMLS CUI [1,2]
- C0020517
Beschrijving
Gender | childbearing potential | pregnancy | serum beta-HCG positive | breastfeeding | sexually active, contraception inadequate | IUD | oral contraceptives
Datatype
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
Beschrijving
Thrombolytic medication | tPA
Datatype
text
Alias
- UMLS CUI [1]
- C0040044
- UMLS CUI [2]
- C0032143
Beschrijving
Neonate | corrected gestational age | bleeding in head on untrasonography
Datatype
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])