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Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding

This study is currently recruiting participants.
Verified by Northport Veterans Affairs Medical Center, August 2007

Sponsors and Collaborators: Northport Veterans Affairs Medical Center
Stony Brook University
Medical College of Georgia
Information provided by: Northport Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT00389935
  Purpose

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


Condition Intervention Phase
Arteriovenous Malformation
Hereditary Hemorrhagic Telangiectasia
Hematochezia
Melena
Drug: Thalidomide 50 - 200 mg once at nightime
Phase IV

Genetics Home Reference related topics:   hemophilia    hereditary hemorrhagic telangiectasia   

MedlinePlus related topics:   Arteriovenous Malformations    Gastrointestinal Bleeding   

ChemIDplus related topics:   Thalidomide   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Screening, Longitudinal, Defined Population, Prospective Study
Official Title:   Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding

Further study details as provided by Northport Veterans Affairs Medical Center:

Estimated Enrollment:   40
Study Start Date:   October 2006
Estimated Study Completion Date:   July 2008

Detailed Description:

Arteriovenous malformations (AVM's) are the most common vascular abnormalities of the gut. Angiodysplasia may be an acquired disorder or inherited as in a hereditary hemorrhagic telangiectasia (HHT). Repeated episodes of obscure 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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Patients must be 18 years of age or older
  • Patient must have had greater than 2 episodes of overt bleeding over last 2 years requiring > 4 units of PRBC for bleeding 20 AVM. AVM's should have been identified at optical/capsule endoscopy or angiography.
  • Patients must have adequate hematologic, renal and liver function (i.e. Platelets ≥ 100,000/mm3, Creatinine ≤ 1.7mg/dl, Total Bilirubin ≤ 1.5mg/dl, Transaminases ≤ 4 times above the upper limits of the institutional norm)
  • Patients must be able to provide written informed consent. Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods (described in detail under thalidomide drug information section) to avoid conception. Women of child-bearing potential must have a negative pregnancy test prior to treatment on this protocol. Men taking thalidomide must agree to use latex condoms every time they have sex with women since it has been shown that thalidomide is found in semen. All patients must agree to participate in the S.T.E.P.S.® program (System for Thalidomide Education and Prescribing Safety). All patients must be educated under the requirements of the S.T.E.P.S.® program. Patients are required to complete a S.T.E.P.S.® survey and sign and additional consent form indicating that they understand all information provided to them as part of the S.T.E.P.S.® educational counseling.
  • Estimated life expectancy must be greater than 2 months.

Exclusion Criteria:

  • Pregnant and/ or lactating female
  • Personal history of thromboembolic disease
  • History of seizure activity
  • History of neoplasm except basal cell carcinoma in-situ
  • History of severe neuropathies
  • Women of child bearing potential
  • Inability to comply with the protocol
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389935

Contacts
Contact: Atul Kumar, MD     631-261-4400 ext 5765    
Contact: Robert Shaw, MD     631-261-4400 ext 2472    

Locations
United States, New York
Northport VAMC     Recruiting
      Northport, New York, United States, 11768
      Contact: Atul Kumar, MD     631-261-4400 ext 5765     atul.kumar2@va.gov    

Sponsors and Collaborators
Northport Veterans Affairs Medical Center
Stony Brook University
Medical College of Georgia

Investigators
Principal Investigator:     Atul Kumar, MD     Northport VAMC    
  More Information


Study ID Numbers:   00198
First Received:   October 17, 2006
Last Updated:   August 30, 2007
ClinicalTrials.gov Identifier:   NCT00389935
Health Authority:   United States: Institutional Review Board;   United States: Federal Government

Keywords provided by Northport Veterans Affairs Medical Center:
Gastrointestinal Bleeding  
Arteriovenous Malformation  
Angiodysplasia  
Hereditary Hemorrhagic Telangiectasia  
Obscure Bleeding  

Study placed in the following topic categories:
Thalidomide
Hereditary hemorrhagic telangiectasia
Cardiovascular Abnormalities
Hematologic Diseases
Telangiectasia, Hereditary Hemorrhagic
Gastrointestinal Diseases
Blood Coagulation Disorders
Gastrointestinal Hemorrhage
Vascular Diseases
Hemorrhage
Hemostatic Disorders
Hemorrhagic Disorders
Digestive System Diseases
Telangiectasis
Vascular Malformations
Arteriovenous Malformations
Congenital Abnormalities

Additional relevant MeSH terms:
Anti-Infective Agents
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Immunosuppressive Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Anti-Bacterial Agents
Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Leprostatic Agents

ClinicalTrials.gov processed this record on September 19, 2008




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