ID
41367
Descripción
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
Palabras clave
Versiones (1)
- 14/9/20 14/9/20 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
14 de septiembre de 2020
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 4.0
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Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858
Eligibility Criteria
- StudyEvent: ODM
Descripción
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Descripción
(dd-mmm-yyyy)
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1320303
Descripción
Gender and age
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0001779
- UMLS CUI [2]
- C0079399
Descripción
Complete appropriate sections on HIT History Form.
Tipo de datos
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
Descripción
Anticoagulation required | positive HIT test | current thrombocytopenia absent
Tipo de datos
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
Descripción
Alternative anticoagulation required | suspected diagnosis of HIT | previous heparin exposure | absence of current platelet count | absence of HIT antibody data
Tipo de datos
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
Descripción
Alternative anticoagulation required | AT-III deficiency | heparin resistance
Tipo de datos
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
Descripción
Informed consent | Informed assent
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0021430
- UMLS CUI [2]
- C5205794
Descripción
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Descripción
(dd-mmm-yyyy)
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1320303
Descripción
Argatroban contraincidation | trial participation dangerous to subject due to medical condition
Tipo de datos
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
Descripción
Unexplained increase of aPPT value | absence of heparin
Tipo de datos
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
Descripción
bleeding diathesis
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0005779
Descripción
INR increased | absence of warfarin therapy
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0525032
- UMLS CUI [1,2]
- C0205217
- UMLS CUI [2,1]
- C0043031
- UMLS CUI [2,2]
- C0332197
Descripción
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
Tipo de datos
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
Descripción
Recent use of investigational medication | Other investigational drug planned during study period
Tipo de datos
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
Descripción
Hypersensitivity to Argatroban
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0048470
- UMLS CUI [1,2]
- C0020517
Descripción
Gender | childbearing potential | pregnancy | serum beta-HCG positive | breastfeeding | sexually active, contraception inadequate | IUD | oral contraceptives
Tipo de datos
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
Descripción
Thrombolytic medication | tPA
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0040044
- UMLS CUI [2]
- C0032143
Descripción
Neonate | corrected gestational age | bleeding in head on untrasonography
Tipo de datos
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])