Obeticholic acid in bile acid diarrhoea (v1.0)

• Research type

  Research Study

• Full title

  Obeticholic acid treatment in patients with bile acid diarrhoea: an open-label, pilot study of mechanisms, safety and symptom response

• IRAS ID

  17441

• Contact name

  Julian Walters

• Sponsor organisation

  Imperial College Healthcare NHS Trust

• Eudract number

  2011-003777-28

• ISRCTN Number

  n/a

• Research summary

  We propose to develop studies of obeticholic acid (OCA) in patients with bile acid diarrhoea. OCA is a semi-synthetic bile acid, also known as 6a-ethyl-chenodeoxycholic acid or INT-747, and is a potent farn'soid-X-receptor (FXR) agon'st. Preliminary data suggests that patients with bile acid diarrhoea have impaired production of the ileal hormone Fibroblast Growth Factor 19 (FGF19). FGF19 is stimulated by FXR agonists, and regulates bile acid synthesis. This study is a pilot, proof-of-concept, open-label study to investigate whether OCA can'stimulate FGF19 in bile acid diarrhoea patients to provide a safe and effective treatment.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  12/LO/0123

• Date of REC Opinion

  7 Feb 2012

• REC opinion

  Favourable Opinion