Hepatitis C Clinical Trial
Official title:
A Phase II, Double-blinded, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Vitalliver in Patients With Decompensated Cirrhosis
Cirrhosis is a diffuse lesion characterized by architectural distortion of the liver because
of collagen deposition and development of nodules of regenerating hepatocytes. It is an
irreversible change that results from diseases characterized by chronic liver injury
(Fujimoto, 2000). Cirrhosis alters the pattern of blood flow through the liver and results
in impaired perfusion of hepatic lobules with intrahepatic and extrahepatic shunting of
blood. This deprives hepatocytes of uniform perfusion by arterial and portal venous blood
resulting in both portal hypertension and other consequences of cirrhosis including impaired
protein synthesis and altered drug metabolism. The histologic diagnosis of cirrhosis
requires the presence of regenerative nodules or pseudolobules completely encircled by
fibrosis such as congenital hepatic fibrosis can result in portal hypertension in the
absence of cirrhosis (Anthony et al., 1977).
The events leading to the development of cirrhosis are generally those of chronic injury
with hepatocyte destruction. Acute severe liver injury as in fulminant viral hepatitis does
not result in cirrhosis and the liver generally returns to normal after recovery. Cirrhosis
can be classified by macroscopic appearance, by cause, and by histologic appearance and
location of liver damage. Micronodular cirrhosis is composed of uniform nodules less than 3
mm in diameter, whereas macronodular cirrhosis has varying size nodules greater than 3 mm
diameter. Mixed nodular cirrhosis has nodules of both sizes. Some liver diseases such as
alcoholic liver disease may present as micronodular cirrhosis and develop larger nodules
with subsequent regeneration of hepatocytes. For this reason, many prefer etiologic
classification (e.g., alcoholic cirrhosis). The designation of cirrhosis as post necrotic,
biliary and portal are still commonly used and imply predominant histologic location of
fibrosis.
Cirrhosis is an irreversible disease, and attempts should be made to stabilize the patient
and to control the cause. Factors that indicate a poor outcome include an elevated
prothrombin time that does not correct itself with parenteral vitamin K, upper
gastrointestinal bleeding caused by varices, ascites refractory to therapy, increased age of
the patient, sever malnutrition, spontaneous bacterial peritonitis, a pronounced increase of
serum bilirubin in the absence of haemolysis, and heptocellular carcinoma (Yeh et al.,
2003). In general, all causes of upper GI bleeding are associated with an increased
mortality in patients with cirrhosis. For those with alcoholic cirrhosis who lack portal
hypertension, survival is similar to an age-matched cohort if alcohol intake is stopped
(Nakamura et al., 1991). If ethanol consumption continues, mortality is higher. Cirrhosis
can be present without clinically significant complications and be identified only at
autopsy or during evaluation of abnormal liver tests (Mendez et al., 2003). However, for
many patients the disease is slowly progressive resulting in one or more complications. The
clinical manifestations of cirrhosis are a result of altered hepatic blood flow through the
liver with intrahepatic shunting causing impaired perfusion of hepatocytes or portal
hypertension with shunting of blood around the liver though portosystemic communications.
The major complications of portal hypertension include oesophageal or gastric varices,
ascites, portosystemic encephalopathy, and hepatorenal-syndrome (Menon & Kamath, 2000). With
impairment of hepatocyte perfusion or reduction of hepatocyte number, altered synthetic
function can result in hypoalbuminemia, hypoprothrombinemia, and changes in drug metabolism.
Vitalliver is a Chinese medicine which is administered in the form of a suppository, which
is uncommon for most Chinese medicines. Medications released from the suppositories are
absorbed directly from the circulation around the rectum and then reach the liver via the
portal vein.
Basic pharmacological studies have shown that Vitalliver has good immunomodulating
functions, increases the activities of T-cells, B-cells and NK cells, therefore this
formulation may have special values in treating liver diseases.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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