Extension Study of RA101495 for Patients With PNH Who Have Completed a Zilucoplan (RA101495) Clinical Study
NCT ID: NCT03225287
Last Updated: 2023-09-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
19 participants
INTERVENTIONAL
2017-07-17
2021-10-26
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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Zilucoplan (RA101495)
Subjects will continue to receive the final maintenance dose they were receiving in the qualifying study
Zilucoplan (RA101495)
Subjects will continue to receive the final maintenance dose they were receiving in the qualifying study.
Interventions
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Zilucoplan (RA101495)
Subjects will continue to receive the final maintenance dose they were receiving in the qualifying study.
Eligibility Criteria
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Inclusion Criteria
* Evidence of ongoing clinical benefit in the opinion of the Investigator
Exclusion Criteria
* Current systemic infection or suspicion of active bacterial infection
18 Years
ALL
No
Sponsors
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Ra Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Dr. Anita Hill
Role: STUDY_CHAIR
St James' Institute of Oncology
Locations
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Investigative Site 4
Los Angeles, California, United States
Investigative Site 19
Dallas, Texas, United States
Investigative Site 3
Gosford, , Australia
Investigative Site 5
Melbourne, , Australia
Investigative Site 10
Toronto, , Canada
Investigative Site 14
Helsinki, , Finland
Investigative Site 9
Ulm, , Germany
Investigative Site 17
Budapest, , Hungary
Investigative Site 13
Christchurch, , New Zealand
Investigative Site 12
Hamilton, , New Zealand
Investigative Site 6
Leeds, , United Kingdom
Investigative Site 7
London, , United Kingdom
Countries
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References
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Kulasekararaj AG, Lehtinen AE, Forsyth C, Gandhi S, Griffin M, Korper S, Mikala G, Muus P, Overgaard U, Patriquin CJ, Pullon H, Shen YM, Spearing R, Szer J, De la Borderie G, Duda PW, Farzaneh-Far R, Ragunathan S, Sayegh CE, Vadysirisack DD, Schrezenmeier H. Phase II trials of zilucoplan in paroxysmal nocturnal hemoglobinuria. Haematologica. 2024 Mar 1;109(3):929-935. doi: 10.3324/haematol.2022.281780. No abstract available.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-003523-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RA101495-01.202
Identifier Type: -
Identifier Source: org_study_id
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