Globally, cirrhosis and liver cancer carries a huge burden and accounts for about 3.5% (2
million) of all deaths every year. Once decompensated, i.e. development of ascites, variceal
bleed, encephalopathy, and jaundice, the life expectancy is markedly reduced to a median of
two years. The definitive treatment in this stage, i.e., liver transplantation is limited by
cost, lack of donors, and life-long immunosuppression.
In addition to complications due to portal hypertension and hepatic insufficiency,
decompensated cirrhosis is associated with malnutrition, sarcopenia, immune dysfunction, and
impaired regeneration. Patients with cirrhosis are growth hormone (GH) resistant, with
reduced insulin-like growth factor, which are linked to malnutrition and poor liver
regeneration in cirrhosis. Diverse preclinical and clinical investigations in vitro and in
vivo, have shown a benefit of GH in GH deficient, elderly and HIV positive patients. GH
therapy in cirrhosis has been shown to improve nitrogen economy and to improve the GH
resistance in a small pilot study by Donaghy et al. Also, GH therapy of short duration has
shown to increase IGF1 levels, IGFBP-3 levels in patients of cirrhosis. GH therapy has also
been shown to improve liver regeneration and protein synthesis after hepatectomy in patients
of HCC with cirrhosis. However, there is a scarcity of data on clinical impact of long term
administration of GH therapy in patients of cirrhosis. Hence, we undertook the present study
to study the effect of growth hormone on clinical outcomes, malnutrition, immune cells and
liver regeneration in patients with cirrhosis.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Postgraduate Institute of Medical Education and Research