Follow-up Protocol to Parts A and B Phase II OPN305-102 Study

• Research type

  Research Study

• Full title

  Follow-up Protocol to the Double-Blind Parts A and B of the Phase II Opsona Study OPN305-102 (A Three-Part, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Sequential Adaptive, Phase II Study to Evaluate the Safety, Tolerability and Efficacy of OPN-305, a Humanised Monoclonal Antibody that Blocks Toll-Like Receptor 2, in Renal Transplant Patients at High Risk of Delayed Graft Function)

• IRAS ID

  145102

• Contact name

  Neil Sheerin

• Contact email

  neil.sheerin@ncl.ac.uk

• Sponsor organisation

  Opsona Therapeutics Ltd

• Eudract number

  2012-005767-27

• Research summary

  This is a follow-up Protocol to the Double-Blind Parts A and B of the Phase II Opsona Study OPN305-102 whereby patients were treated for six months on OPN305-102
  The study is a follow-up study out to 12 months following OPN-305 or placebo administration of the clinical status and graft function of patients who participated in and completed the 6-month double-blind part A or B of the phase II study described above. The follow-up of patients who participated in the open-label Phase 0 of the phase II protocol is described in a separate Opsona protocol (OPN305-104).

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  14/NE/0065

• Date of REC Opinion

  31 Mar 2014

• REC opinion

  Favourable Opinion