REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate Its Long Term Safety, Efficacy and Tolerability.
NCT ID: NCT04162470
Last Updated: 2023-06-12
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
24 participants
INTERVENTIONAL
2019-12-03
2022-04-07
Brief Summary
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The secondary objectives of the study are:
* To evaluate the long-term effect of REGN3918 on intravascular hemolysis
* To assess the concentrations of total REGN3918 in serum
* To evaluate the occurrence of the immunogenicity of REGN3918
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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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REGN3918
Participants who have completed 1 of the 2 parent studies (R3918-PNH-1852 \[NCT03946748\] or R3918-PNH-1853)
REGN3918
Subcutaneous (SC) every week (QW) over the treatment period
Interventions
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REGN3918
Subcutaneous (SC) every week (QW) over the treatment period
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Any new condition or worsening of an existing condition which, in the opinion of the investigator, would make the patient unsuitable for enrollment or could interfere with the patient participating in or completing the study
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Regeneron Study Site
Shatin, , Hong Kong
Regeneron Study Site
Budapest, , Hungary
Regeneron Study Site
Miri, Sarawak, Malaysia
Regeneron Study Site
Sibu, Sarawak, Malaysia
Regeneron Study Site
Kuala Terengganu, Terengganu, Malaysia
Regeneron Study Site
Busan, , South Korea
Regeneron Study Site
Seoul, , South Korea
Regeneron Study Site
Seoul, , South Korea
Regeneron Study Site
Seoul, , South Korea
Regeneron Study Site
Seoul, , South Korea
Regeneron Study Site
Seoul, , South Korea
Regeneron Study Site
Taipei, , Taiwan
Regeneron Study Site
Taoyuan, , Taiwan
Regeneron Study Site
Leeds, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-000130-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
R3918-PNH-1868
Identifier Type: -
Identifier Source: org_study_id
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