A Randomized, Open-label, Two-arm Study to Evaluate the Safety, Efficacy, and Pharmacodynamic Effects of Pozelimab and Cemdisiran Combination Treatment in Patients with Paroxysmal Nocturnal Hemoglobinuria Who Have Received Pozelimab Monotherapy

Regeneron Pharmaceuticals, Inc.0 个研究点目标入组 24 人开始时间: 2021年3月5日最近更新: 2021年5月17日

适应症

试验速览

暂无简介。

•1. Patients with PNH who are receiving treatment with pozelimab monotherapy in the R3918- PNH-1868 study
•2. Provide informed consent signed by study patient
•3. Willing and able to comply with clinic/remote visits and study-related procedures
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 4

•1. 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
•2. 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
•3. Significant protocol deviation(s) in the parent study based on the investigator’s judgment as described in the protocol
•4. 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
•5. Known hypersensitivity to cemdisiran or any component of cemdisiran formulation
•NOTE: Other protocol-defined Exclusion Criteria apply

发起方