Status:
COMPLETED
Pozelimab and Cemdisiran Combination Treatment in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Who Have Received Pozelimab Monotherapy
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Paroxysmal Nocturnal Hemoglobinuria
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of the study is to evaluate the safety and tolerability of 2 dosing regimens of pozelimab and cemdisiran combination therapy during the open-label treatment period (OLTP) The se...
Eligibility Criteria
Inclusion
- Key
- 1\. Participants with PNH who are receiving treatment with pozelimab monotherapy in the R3918- PNH-1868 study (NCT04162470)
- Key
Exclusion
- Documented, positive polymerase chain reaction (PCR) or equivalent test based on regional recommendations for COVID-19 or suspected SARS-CoV-2 infection as defined in the protocol
- Participants with documented history of liver cirrhosis or participants with liver disease with evidence of currently impaired liver function; or participants with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) as described in the protocol
- Significant protocol deviation(s) in the parent study based on the investigator's judgment as described in the protocol
- Any new condition or worsening of an existing condition which, in the opinion of the investigator, would make the participant unsuitable for enrollment or would jeopardize the safety of the participant
- Known hypersensitivity to cemdisiran or any component of cemdisiran formulation
- NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply
Key Trial Info
Start Date :
July 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04811716
Start Date
July 29 2021
End Date
October 18 2023
Last Update
April 8 2025
Active Locations (13)
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1
Prince of Wales Hospital
Hong Kong, New Territories, Hong Kong, 550540
2
D l Pesti Centrumk rh z Orsz gos Hematol giai s Infektol giai Int zet
Budapest, Nagyvárad Tér 1, Hungary, 1907
3
Hospital Miri
Miri, Sarawak, Malaysia, 98000
4
Hospital Sibu
Sibu, Sarawak, Malaysia, 96000