ID

41463

Descrição

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 Head Ultrasound Form has to be filled only for neonate patients with a corrected gestational age of <44 weeks at enrollment, three times during the study at three timepoints: 1) Baseline up to 96 hours before treatment initiation; and 2) Up to 24 hours after becoming therapeutically anticoagulated; and 3) No more than 24 hours following discontinuation of treatment infusion or at the 30-day follow-up visit, whichever comes first.

Link

https://clinicaltrials.gov/ct2/show/NCT00039858

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Versões (1)

1. 18/10/2020 18/10/2020 -

Titular dos direitos

GlaxoSmithKline

Transferido a

18 de outubro de 2020

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