Secondary Prophylaxis of Gastrointestinal Bleeding in Cirrhotic Patients Using THALIDOMIDE

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00787436
• Date of registration: 05/11/2008
• Primary sponsor: The Cleveland Clinic
• Public title: Secondary Prophylaxis of Gastrointestinal Bleeding in Cirrhotic Patients Using THALIDOMIDE
• Scientific title: Secondary Prophylaxis of Gastrointestinal Bleeding in Cirrhotic Patients Using Thalidomide
• Date of first enrolment: May 2006
• Target sample size: 100
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00787436
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Countries of recruitment

United States

Contacts

• Name: Paula Freeman-Vida, B.S. R.N

Key inclusion & exclusion criteria

Inclusion Criteria:

- Endoscopic confirmation or portal hypertension related GI bleeding

- Over the age of 18 with the ability to willingly sign an informed consent

- Adequate performance status and cognitive ability

- Patients must be willing to comply with all FDA-mandated prescribing and safety while
taking Thalidomide

- Hemodynamically stable with no evidence of ongoing bleeding (defined as a Hgb that
has not varied by more than 10% over 12 hour period.)

Exclusion Criteria:

- No other serious illness or medical condition including unstable cardiac disease
requiring treatment, new onset crescendo or rest angina. Stable exertional angina is
acceptable.

- No history of significant neurological or psychiatric disorders including psychotic
disorders, dementia, or seizures or active infection



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Gastrointestinal Hemorrhage

Portal Hypertension

Intervention(s)

Drug: Thalidomide

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

Secondary ID(s)

34-0714585

CEL-20237

FWA00005367

IRB00000536

OSR-20070905-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Celgene Corporation