Commodore 1

• Research type

  Research Study

• Full title

  A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF CROVALIMAB VERSUS ECULIZUMAB IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) CURRENTLY TREATED WITH COMPLEMENT INHIBITORS

• IRAS ID

  1003391

• Contact name

  Head of EU Product Development Regulatory

• Sponsor organisation

  F.Hoffmann-La Roche Ltd

• Eudract number

  2020-000597-26

• Clinicaltrials.gov Identifier

  NCT04432584

• Research summary

  This study is comparing a new treatment against Soliris, a already approved medication, to evaluate which treatment is safer and more effective for patients with Paroxysmal Nocturnal Hemoblobinuria (PNH), a rare blood disease that causes the red blood cells to break apart, due to a missing protein on the patients blood cells surface while receiving complement inhibitors (medication that can stop the auto attacks of the body, here red blood cells)

• REC name

  West of Scotland REC 1

• REC reference

  21/WS/0008

• Date of REC Opinion

  30 Mar 2021

• REC opinion

  Further Information Favourable Opinion