Efficacy and Safety of N8 in Haemophilia A Subjects
Tracking Information
Start Date ICMJE | April 2009 |
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Estimated Primary Completion Date | August 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: February 9, 2009) | Amount of N8 used and bleeding rates and response to treatment as assessed by the physician, patient or caregiver [ Time Frame: during 6-8 months of treatment ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00840086 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: February 9, 2009) | Inhibitor development [ Time Frame: during 6-8 months of treatment ] [ Designated as safety issue: No ] |
Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Efficacy and Safety of N8 in Haemophilia A Subjects |
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Official Title ICMJE | A Multi-centre, Open-label, Non-controlled Trial on Efficacy and Safety of N8 in Prevention and On-demand Treatment of Bleeding Episodes in Previously Treated Subjects With Haemophilia A. Sub-trial: Efficacy and Safety of N8 in Prevention and Treatment of Bleeding During Surgical Procedures in Subjects With Haemophilia A |
Brief Summary | This trial is conducted in Africa, Asia, Europe, Japan, Oceania, and North and South America. The trial consists of a main trial and a sub-trial. The main trial investigates efficacy and safety of recombinant factor VIII (N8) in haemophilia A subjects, while the sub-trial investigates efficacy and safety of N8 in prevention and treatment of bleeding during surgical procedures. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group 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
Estimated Enrollment ICMJE | 140 | ||||
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Estimated Completion Date | August 2011 | ||||
Estimated Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Male | ||||
Ages | 12 Years to 65 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Brazil, Croatia, Denmark, Germany, Hungary, Israel, Italy, Japan, Russian Federation, Serbia, Spain, Switzerland, Taiwan, Turkey, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00840086 | ||||||||
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Responsible Party | Public Access to Clinical Trials, Novo Nordisk A/S | ||||||||
Study ID Numbers ICMJE | NN7008-3543, EudraCT No: 2008-003960-20 | ||||||||
Study Sponsor ICMJE | Novo Nordisk | ||||||||
Collaborators ICMJE | |||||||||
Investigators ICMJE |
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Information Provided By | Novo Nordisk |
Source: http://clinicaltrials.gov/