Safety and Efficacy of N8 in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543 and NN7008-3545

Status: Recruiting
Phase:
Diagnosis: Pediatric Hematology/Blood Related
NCT ID: NCT00984126 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID:

 

This trial is conducted in Asia, Europe, Japan, Oceania, North America and South America. The aim of this clinical trial is to investigate safety and efficacy of N8 in Haemophilia A patients. This trial is an extension to trials NN7008-3543 (start: March 2009, stop: September 2011) and NN7008-3545 (start: May 2010, stop: January 2012)

 

Conducting Institutions:
Children's Hospital Boston, Dana-Farber Cancer Institute

Overall PI:
Kapil Saxena, MD, Children's Hospital Boston

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

Eligibility Criteria

Inclusion Criteria: - Informed Consent obtained before any trial-related activities - Completion of trial NN7008-3543 or paedriatric trial NN7008-3545 or Japanese trial NN7008-3600 or pharmacokinetic trial NN7008-3893 Exclusion Criteria: - Previous participation in the current trial (defined as withdrawal) or withdrawn subjects from NN7008-3522, NN7008-3543, NN7008-3545, NN7008-3600 or NN7008-3893 after administration of trial product
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