CDSCO Panel Grants Roche's Protocol Amendment Proposal For Crovalimab study
Written By : Dr. Divya Colin
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-03-16 12:00 GMT | Update On 2024-03-21 15:31 GMT
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New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Roche's protocol amendment proposal for the clinical trial titled "A study evaluating the efficacy, safety, pharmacokinetics, and pharmacodynamics of crovalimab in pediatric participants with the atypical hemolytic uremic syndrome (aHUS) (COMMUTE-p)".
This came after the drug major Roche presented protocol amendment version 4 dated 29 July 2022 and version 5 dated 18 May 2023, protocol No.:BO42354. This study aims to evaluate the efficacy and safety of crovalimab in pediatric participants with aHUS.
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