ID
41343
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 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 This Form has to be filled in at the screening visit. It is used to record whether Informed Consent/Assent has been given by the Subject and also demographic data of the Subject.
Link
https://clinicaltrials.gov/ct2/show/NCT00039858
Keywords
Versions (2)
- 8/31/20 8/31/20 -
- 9/2/20 9/2/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
September 2, 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
Informed Consent/Assent, Demographics
- StudyEvent: ODM
Description
Informed Consent/Assent
Alias
- UMLS CUI-1
- C0021430
Description
Demographics
Alias
- UMLS CUI-1
- C0011298
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
gender
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Duration of gestation
Data type
integer
Measurement units
- weeks
Alias
- UMLS CUI [1]
- C0460089
Description
*Minimum corrected gestational age must be 37 weeks. If <44 weeks, a head ultrasound is required per protocol. (Record head ultrasound results on page 19 - Head Ultrasound Form.)
Data type
integer
Measurement units
- weeks
Alias
- UMLS CUI [1]
- C3831006
Description
Race
Data type
text
Alias
- UMLS CUI [1]
- C0034510
Description
Other race, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C3845569
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Informed Consent/Assent, Demographics
- StudyEvent: ODM
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