ID
41479
Description
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 - See https://clinicaltrials.gov/ct2/show/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. The Supplemental HIT Assay Data Page is used to record any HIT Assays performed during the course of the Study.
Link
https://clinicaltrials.gov/ct2/show/NCT00039858
Keywords
Versions (1)
- 10/24/20 10/24/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 24, 2020
DOI
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License
Creative Commons BY-NC 4.0
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Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858
Supplemental HIT Assay Data Page
- StudyEvent: ODM
Description
Supplemental HIT Assay Data Page
Alias
- UMLS CUI-1
- C0522876
- UMLS CUI-2
- C1706499
Description
Type of HIT assay
Data type
integer
Alias
- UMLS CUI [1,1]
- C0332307
- UMLS CUI [1,2]
- C0522876
Description
Comments
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0522876
Description
HIT assay result
Data type
text
Alias
- UMLS CUI [1,1]
- C0522876
- UMLS CUI [1,2]
- C1274040
Similar models
Supplemental HIT Assay Data Page
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
C1706499 (UMLS CUI-2)
C0522876 (UMLS CUI [1,2])