AG348-C-010

• Research type

  Research Study

• Full title

  A PHASE 2, OPEN-LABEL, MULTICENTER STUDY TO DETERMINE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF AG-348 IN ADULT SUBJECTS WITH NON TRANSFUSION-DEPENDENT THALASSEMIA

• IRAS ID

  250410

• Contact name

  Mark Layton

• Contact email

  m.layton@imperial.ac.uk

• Sponsor organisation

  Agios Pharmaceuticals, Inc.

• Eudract number

  2018-002217-35

• Duration of Study in the UK

  3 years, 0 months, 0 days

• Research summary

  The purpose of this study is to evaluate the efficacy of treatment with AG-348 for the treatment of thalassemia as well as the safety and tolerability of AG-348. The Sponsor also wants to evaluate the amount of study drug that gets into the blood and how long it stays in the blood (pharmacokinetics or PK) and what the study drug does in the body (pharmacodynamics or PD).

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  18/SW/0219

• Date of REC Opinion

  20 Nov 2018

• REC opinion

  Further Information Favourable Opinion