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
Tracking Information
Start Date ICMJE | October 2009 |
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Estimated Primary Completion Date | April 2010 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: September 24, 2009) |
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Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00984126 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: September 24, 2009) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | 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 |
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Official Title ICMJE | Safety and Efficacy of N8 in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A |
Brief Summary | 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: August 2011) and NN7008-3545 (start: April 2010, stop: January 2012) |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Haemophilia A |
Intervention ICMJE |
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Study Arms / Comparison Groups | A: Experimental Interventions:
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Recruitment Information
Recruitment Status ICMJE | Recruiting | ||||
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Estimated Enrollment ICMJE | 145 | ||||
Estimated Completion Date | June 2018 | ||||
Estimated Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Male | ||||
Ages | 6 Months to 70 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Brazil, Croatia, Denmark, Germany, Israel, Russian Federation, Serbia, Spain, Switzerland, Taiwan, Turkey, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00984126 | ||||
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Responsible Party | Public Access to Clinical Trials, Novo Nordisk A/S | ||||
Study ID Numbers ICMJE | NN7008-3568, EudraCT No: 2008-005945-46, UTN: U1111-1111-9377 | ||||
Study Sponsor ICMJE | Novo Nordisk | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Novo Nordisk |
Source: http://clinicaltrials.gov/