Date: 2017-04-20
Type of information: Clinical research agreement
Compound:
Company: Allergan (Ireland) TARGET PharmaSolutions
Therapeutic area: Hepatic diseases - Liver diseases
Type agreement: clinical research
Action mechanism:
Disease: NASH (non-alcoholic steatohepatitis), NAFLD (non-alcoholic fatty liver disease)
Details: • On April 20, 2017, Allergan announced that it will collaborate with TARGET PharmaSolutions, a clinical data company focused on real world evidence, on its TARGET-NASH study. TARGET-NASH is a five-year longitudinal observational study that looks at patients with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH). TARGET-NASH was launched in advance of related drug approvals in order to help facilitate a greater understanding of the impact of NASH and future treatment options. TARGET-NASH involves academia, industry, regulatory agencies and the NASH/NAFLD community. The first patient enrollment occurred August 1, 2016, and over the course of the five-year study the program looks to enroll 15,000 adults and children with NAFLD or NASH. The study design is disease focused, not drug specific, allowing for continuous acquisition of natural history and outcomes data as new drugs enter the market and clinical treatment paradigms evolve. TARGET PharmaSolutions' TARGET study model is based on the success of HCV-TARGET, a case study in Hepatitis C. Formed in 2011 by Drs. Michael Fried, MD (University of North Carolina) and David Nelson, MD (University of Florida), HCV-TARGET has enrolled over 10,000 patients and has generated data that has been used by physicians, payers, and regulatory agencies around the world.
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