• The proposed study would use a novel approach to prophylaxis, using thalidomide, an oral TNF inhibitor, in conjunction with a betablocker to prevent rebleeding of upper gastrointestinal bleeding in patients with cirrhosis and portal hyperte [ Time Frame: 16 week duration ] [ Designated as safety issue: Yes ]
  

• The secondary endpoint is to examine the impact on progression of liver disease in this population, including development of other complications of chronic liver disease, such as encephalopathy, hepatorenal syndrome and patient survival [ Time Frame: 16 week duration ] [ Designated as safety issue: Yes ]
  

Treatment duration with thalidomide will be for 16 weeks, beginning in the hospital setting immediately after the index bleed, and clinical follow-up additional six months. Follow-up in both the hepatology, outpatient clinic area and the endoscopy suite will occur. Step wise thalidomide dosing will be 100 mg/d once a day at night. If no evidence of toxicity is noted after 5 doses, the dose will be increased to 200 mg/d, and continued on that dose as an outpatient until completion of the study protocol at 16 weeks. Patients will be followed daily while inpatients, and subsequently at two-week intervals upon discharge. Females of child-bearing potential will be seen weekly for the first month and must have a confirmed negative pregnancy test prior to being dispensed the next one week supply of study drug. After the first month, females of child-bearing potential will be seen every two weeks as will all other subjects. Standard follow-up medical care after esophageal variceal bleeding in patients who have undergone endoscopic therapy will include:

follow-up endoscopy at regular intervals until variceal obliteration, using either endoscopic variceal ligation (EVL) or sclerotherapy titrated dose of a nonselective beta blocker (propranolol).

At each follow-up visit, patients will be assessed for development of any interim outcome of interest:

overt upper gastrointestinal bleeding need for transfusion worsening clinical status

Patients will initially be followed daily while hospitalized. outpatient visits will occur every two-week intervals upon discharge. Standard follow-up medical care after esophageal variceal bleeding in patients who have undergone endoscopic therapy will include:

follow-up endoscopy at regular intervals until variceal obliteration, using either endoscopic variceal ligation (EVL) or sclerotherapy titrated dose of a nonselective beta blocker (propranolol).

At each follow-up visit, patients will be assessed for development of any interim outcome of interest:

overt upper gastrointestinal bleeding need for transfusion worsening clinical status the need for TIPS, liver transplantation or death. In addition, patients and their families will be questioned for any evidence of potential toxicity as assessed by using the CTC Toxicity grade version 3, or adverse outcomes by one of the study investigators as well as a nurse coordinator, using a standardized questionnaire along with a regular clinical