Status:
WITHDRAWN
Secondary Prophylaxis of Gastrointestinal Bleeding in Cirrhotic Patients Using THALIDOMIDE
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
Celgene Corporation
Conditions:
Gastrointestinal Hemorrhage
Portal Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The natural history of cirrhosis has a symptomatic and asymptomatic stage. The symptoms include the development of ascites, hepatic encephalopathy, or variceal bleeding. The development of portal hype...
Detailed Description
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 hepat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00787436
Start Date
May 1 2006
End Date
January 1 2010
Last Update
July 31 2013
Active Locations (1)
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1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44109