NASH


NASH (Nonalcoholic Steatohepatitis)

20%-30% of people with non-alcoholic fatty liver disease (NAFLD) gradually progress to non-alcoholic steatohepatitis (NASH) by which stage it is characterised by inflammation and liver damage, including various stages of fibrosis. NASH is massively under-diagnosed, partly because it is a silent disease with few, often-mild symptoms and partly because definitive diagnosis is by histopathology of a liver biopsy which the treating physician or patient may prefer not to perform and/or provide. 

ICON offers expertise in the development and management of all aspects of NASH clinical trials from the earliest development to the late post – marketing environment. Our clinical trial experience includes:

  • NASH experienced project team with proven ability to deliver 
  • NASH therapeutic area expertise 
  • Innovative site selection
  • Focus on recruiting and retaining patients through technology like Firecrest

ICON provides an extensive range of clinical research solutions, along with deep therapeutic area expertise to help you gain insights into the complexities of NASH. Strengthened by the robust infrastructure of a full-service CRO and 26 years of experience in clinical research, our NASH-focused offerings can be engaged anywhere in your clinical development pipeline.

A Range of Clinical Research Solutions for NASH

Download our brochure to learn about our extensive range of clinical research solutions and our therapeutic area of expertise to help you gain insights into the complexities of NASH. 

Navigating NASH Clinical Trials ThumbnailNavigating NASH Clinical TrialsDownload Brochure

Laboratory Services for NASH

ICON’s fully harmonised and standardised global central laboratory services provide analytical methodologies with industry-leading accuracy for key NASH endpoints.

Anatomical/Digital Pathology 

  • Tissue procesing
  • ​Embedding & sectioning
  • H&E staining
  • Long term storage solution
  • Histopathological assessment by NASH pathologists

NASH Biomarker Analysis

  • Fibrosis
  • ​ELF
  • Liver (AST, ALT)
  • Inflammation
  • Protocol-specific genetic markers   

Medical Imaging

ICON Medical Imaging collaborates with a NASH CRN radiologist to provide comprehensive imaging solutions that may partially substitute for invasive liver biopsies during earlier phase studies.

Services include:

  •  Various modalities: MRI-PDFF, MR Elastography, T2* (iron), MRS
  • Documented site training
  • Phantom data collection, QC, and processing
  • Ongoing image collection, QC, and processing
  • Liver ROI generation
  • Expert image-data & quantitative analysis
  • Expert central readers and KOLs

Case Study: Expediting Eligibility Review in Hepatic Steatosis Trials 

Learn how ICON’s medical imaging experts provided strategic advice on the design and development for a randomized, placebo-controlled Phase II study on hepatic steatosis.

Medical Imaging: Expediting Eligibility Review in Hepatic Steatosis Trials ThumbnailMedical Imaging: Expediting Eligibility Review in Hepatic Steatosis TrialsDownload Case Study

Project Management
Our experienced Project Management teams are available to provide support 24/7 and have the proven ability to deliver in all major regions, including the US, EU, and Asia.

Early Phase Services
Expedite and enhance your clinical development programme by taking advantage of our established population of NASH subjects and expert imaging capabilities, including multiparametric MRI techniques. 

Patient Enrolment & Engagement Uncover patients with an underdiagnosed disease

  • Site Alliance Network: ICON’s dedicated Site Alliance Network of 100 hospitals and 900 qualified investigators.    
  • Patient Access: Utilisation of a  regional healthcare system in the United States that covers 1400 clinics, 22 hospitals, and 50 million unique patients. By applying codes within EHRs for NASH, our experts have identified 1,280,087 potential participants.

FIRECREST

Enhance patient engagement and retention with FIRECREST. With robust training features on biopsy requirements, FIRECREST is an ideal solution for investigator sites that lack experience in NASH.

  • Active in over 1000 clinical trials worldwide
  • Platform currently serves more than 440,000 users, including hepatologists and gastroenterologists.

Commercialisation

Optimise phase II and late-phase NASH research through commercial strategy and value-driven communication plans. Our experts provide integrated services for evidence generation, which are designed to enhance value strategy during programme design, product development, and post-marketing.