Open Label Study of the Efficacy and Long Term Safety of LUM001, an Apical Sodium-Dependent Bile Acid Transporter Inhibitor (ASBTi), in the Treatment of Cholestatic Liver Disease in Pediatric Patients With Progressive Familial Intrahepatic Cholestasis
Active, no longer recruiting
Phase of Trial: Phase II
Latest Information Update: 31 Oct 2017
At a glance
- Drugs Lopixibat chloride (Primary)
- Indications Intrahepatic cholestasis
- Focus Adverse reactions; Therapeutic Use
- Acronyms INDIGO
- Sponsors Lumena Pharmaceuticals; Shire
- 24 Oct 2017 Interim results at week 48 (n=33) presented at The Liver Meeting 2017: 68th Annual Meeting of the American Association for the Study of Liver Diseases
- 02 Mar 2017 Planned End Date changed from 1 Feb 2018 to 1 Aug 2018.
- 02 Mar 2017 Planned primary completion date changed from 1 Feb 2018 to 1 Aug 2018.