E07-001: Safety and Efficacy Extension Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients
NCT ID: NCT01194804
Last Updated: 2019-09-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
27 participants
INTERVENTIONAL
2008-04-30
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Eculizumab
Treatment with eculizumab for patients with PNH who have successfully completed the C07-001 protocol
Eculizumab
Each vial contains 30 mL of 10 mg/mL eculizumab; dose of 900 mg intravenous every 14 days.
Interventions
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Eculizumab
Each vial contains 30 mL of 10 mg/mL eculizumab; dose of 900 mg intravenous every 14 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
12 Years
ALL
No
Sponsors
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CMIC Co, Ltd. Japan
INDUSTRY
Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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References
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Kanakura Y, Ohyashiki K, Shichishima T, Okamoto S, Ando K, Ninomiya H, Kawaguchi T, Nakao S, Nakakuma H, Nishimura J, Kinoshita T, Bedrosian CL, Ozawa K, Omine M. Long-term efficacy and safety of eculizumab in Japanese patients with PNH: AEGIS trial. Int J Hematol. 2013 Oct;98(4):406-16. doi: 10.1007/s12185-013-1404-y. Epub 2013 Aug 11.
Other Identifiers
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E07-001
Identifier Type: -
Identifier Source: org_study_id
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