Chronic Liver Disease Clinical Trial
Official title:
Increlex Treatment of Children With Chronic Liver Disease and Short Stature
A major consequence of chronic liver disease in childhood is growth failure. This is because
a chemical essential for growth called growth factor is created in the liver. Lack of
response to growth hormone in people with chronic liver disease is characterized by high
levels of growth hormone and low levels of growth factors. This growth hormone resistance is
reflected in a variety of factors including insulin resistance and low nutritional intake.
Unfortunately, growth hormone therapy has no effect for children with liver disease. In
addition, failure of normal growth or malnutrition makes liver disease even worse in
children, and growth hormone therapy is not likely to reverse this. A lack of proper
nutrition is associated with hospitalizations and frequent complications. Poor growth is a
predictor of poor outcomes after liver transplantation. Thus the management of children with
liver disease remains a challenge. Children who have successful orthotopic liver transplants
(OLT) show much improvement in some aspects of growth, including skin fold thickness,
mid-arm circumference, and normalization of growth factor levels. However, some studies have
recently reported that the growth of 15-20% of children remains poor even after a liver
transplant. This can be explained by persistent abnormalities in growth factors after
transplant.
Growth factor was found to be a good tool for prognosis in patients with chronic liver
disease. Studies showed that patients with liver cirrhosis and growth factor levels below
normal values showed lower long-term survival rates compared with patients who had above
normal values. This suggests that growth factor can be a good predictor of survival and
early marker of poor liver function. In this case, aggressive feeding may modestly improve
growth factor levels leading to improved growth but it is unlikely that effects will be
optimal. The investigators propose that growth factor administration may have a positive
effect that leads to better growth which is a major predictor of good outcome. To date, no
reports study the use of growth factor in children with chronic liver disease. This study
proposes to examine the effect of growth factor therapy in childhood chronic liver disease.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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