A large observational study is looking at how doctors manage people with nonalcoholic steatohepatitis (NASH) or nonalcoholic fatty liver disease (NAFL).
The companies started the five-year TARGET-NASH study (NCT02815891) ahead of regulatory approval of new treatments that are in the pipeline. The goal is to build a 15,000-strong registry of patients with NAFL or NASH who are already under treatment. The companies want to evaluate the effectiveness and safety of current medicines and future therapies.
“Allergan is focused on identifying, developing and bringing forward innovative treatments for patients with significant unmet medical needs, such as non-alcoholic steatohepatitis (NASH),” David Nicholson, the company’s chief research and development officer, said in a press release. “NASH is an emerging healthcare crisis affecting both adults and children. This unique collaboration will help to further our collective understanding of the disease, effective modes of treatment and outcomes across the spectrum of patient groups.”
The trial is being conducted at 32 sites across the United States.The first patient enrolled in August 2016, and researchers continue to recruit participants. More information is available by clicking on the clinical trials.gov webpage.
A disease-focused rather than therapy-focused study, it aims to create a better understanding of the history of liver disease. Those conducting the study hope to involve academia, industry, and regulatory agencies.
Researchers will analyze patients’ demographic data, the medications they are taking, other metabolic and cardiovascular diseases they have, and the stages of NAFL and NASH that doctors are treating. They will also evaluate the various treatment regimens.
“TARGET-NASH is critical for the scientific and regulatory community as we prepare for new agents for the treatment of NASH,” said Dr. Arun Sanyal, co-chair of the TARGET-NASH steering committee. “In the immediate term, it will give us a critical understanding of NASH diagnosis and management in the real world across multiple populations. In the longer term, it is the perfect platform to have a deep understanding of the safety and effectiveness of these new agents across populations not included, or underrepresented, in Phase 3 clinical trials.”
In related news
A new review suggests that statins — used primarily to manage cholesterol — may be effective in treating liver inflammation and chronic liver disease.
Statins are often prescribed to people at high risk of cardiovascular disease. The review covered more than 50 studies published in the American Journal of Physiology—Gastrointestinal and Liver Physiology. It suggests that statin use may reduce inflammatory molecules associated with chronic liver disease, leading to improved outcomes in these patients. The full article can be read here.