Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding — TAG  

Hereditary Hemorrhagic Telangiectasia Clinical Trial

Official title: Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding

Status Completed

Clinical Trial Summary

The purpose of this study is to determine whether Thalidomide is effective in the treatment of arteriovenous malformations in the gastrointestinal tract.

Clinical Trial Description

Arteriovenous malformations (AVM's) are the commonest vascular abnormalities of the gut. AVM's or Angiodysplasia may be acquired or inherited as in a hereditary hemorrhagic telangiectasia (HHT). Repeated episodes of gastrointestinal bleeding (GIB), especially in the elderly have been attributed to angiodysplasia. Clinically significant GIB may be also seen in up to 40% of HHT patients, usually in the fourth and fifth decades of life. GIB may manifest both as acute major hemorrhage, slow intermittent blood loss or a combination of these findings and patients may be symptomless, present with acute bleeding or iron deficiency anemia. Recurrent hemorrhage and persistent iron-deficiency anemia is common despite supplemental iron therapy and patients require repeated transfusions. Amongst patients with preexisting co-morbidities, repeated bleeding may lead to significant morbidity and mortality. Furthermore, re-bleeding among these patients consumes a disproportionate share of healthcare resources devoted to multiple admissions, repeated endoscopies and blood transfusions. There are no effective treatment options available currently. The purpose of this study is to determine whether Thalidomide is effective in the treatment of arteriovenous malformations in the gastrointestinal tract. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriovenous Malformation
• Arteriovenous Malformations
• Congenital Abnormalities
• Gastrointestinal Hemorrhage
• Hemangioma
• Hematochezia
• Hereditary Hemorrhagic Telangiectasia
• Melena
• Telangiectasia, Hereditary Hemorrhagic
• Telangiectasis

• NCT number: NCT00389935
• Study type: Interventional
• Source: Northport Veterans Affairs Medical Center
• Status: Completed
• Phase: Phase 2
• Start date: October 2006
• Completion date: July 2011