Massachusetts General Hospital
MGH has a few in the pipeline that they anticipate to be starting in the next 3-4 months (mainly NASH and HCV). In terms of MGH trials – the LiverResearchGroup@partners.org is a great contact to give out if people are just looking to hear more about what’s available, etc.
* Intercept – drug Obeticholic Acid (ClinicalTrials.gov Identifier: NCT02548351)
Population: NASH + Fibrosis stage 1-3
Study Phase: 3
Treatment period: up to 5 years (interim analysis at 18 months)
Randomization: 1:1:1 (placebo/10mg/25mg)
* Genfit – drug Elafibranor
Population: NASH + Fibrosis (stage 1-4)
Treatment period: 72 weeks with long term treatment rollover (up to 4 additional years)
Study Phase: 3
Randomization: 2:1 (120mcg/placebo)
* Conatus12 – drug Emricasan (ClinicalTrials.gov Identifier: NCT02686762)
Population: NASH + Fibrosis stage 1-3
Treatment period: 72 weeks + 4 weeks follow-up
Study Phase: 2
Randomization: 1:1:1 (placebo/5mg/50mg)
* Novartis – drug LJN452 (ClinicalTrials.gov Identifier: NCT02855164)
Population: NASH + Fibrosis (stage 1-3)
Treatment period: 12 weeks
Study Phase: 2
Randomization: Part A: 1:1:1:1:1 (10mg/30mg/60mg/90mg/placebo)
NASH Cirrhosis
* Conatus14 – Emricasan (ClinicalTrials.gov Identifier: NCT02960204)
Population: NASH + Cirrhosis + Severe Portal Hypertension (HVPG > 12)
Treatment period: 24 weeks
Study Phase: 2
Randomization: 1:1:1:1 (placebo/5mg/25mg/50mg)
HCV
* Gilead – drug Harvoni (ClinicalTrials.gov Identifier: NCT02503735)
Population: Chronic Kidney Disease + HCV
Treatment period: 12 weeks
Study Phase: 4
Randomization: open label (no placebo)
* AbbVie – drug Viekira Pak (ClinicalTrials.gov Identifier: NCT02946034)
Population: Chronic Kidney Disease + HCV
Treatment period: 12 weeks
Study Phase: 4
Randomization: open label (no placebo)
Contact JLGustafson@partners.org (MGH Liver Research Group) for more information.
Phone: 617-724-3836
Email: LiverResearchGroup@partners.org
