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Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding (TAG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00389935
Recruitment Status : Completed
First Posted : October 19, 2006
Last Update Posted : August 2, 2011
Sponsor:
Collaborators:
Augusta University
University of Massachusetts, Worcester
Information provided by:
Northport Veterans Affairs Medical Center

Study Description
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Brief Summary:
The purpose of this study is to determine whether Thalidomide is effective in the treatment of arteriovenous malformations in the gastrointestinal tract.

Condition or disease Intervention/treatment Phase
Arteriovenous Malformation Hereditary Hemorrhagic Telangiectasia Hematochezia Melena Drug: Thalidomide Phase 2

Detailed 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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding
Study Start Date : October 2006
Actual Primary Completion Date : June 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Thalidomide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Drug: Thalidomide
Thalidomide 50 - 200 mg once at nightime


Outcome Measures
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Primary Outcome Measures :
  1. Blood Transfusion requirements [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Hemoglobin overall complication rate Constipation Neuropathy [ Time Frame: 6 month ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 ≤ 2.5mg/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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389935


Locations
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United States, Georgia
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Massachusetts
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, New York
Northport VAMC
Northport, New York, United States, 11768
Sponsors and Collaborators
Northport Veterans Affairs Medical Center
Augusta University
University of Massachusetts, Worcester
Investigators
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Principal Investigator: Atul Kumar, MD Northport VAMC
Principal Investigator: James Gossage, MD Augusta University
More Information
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Responsible Party: Atul Kumar, US Veterans Affairs Medical Center Northport
ClinicalTrials.gov Identifier: NCT00389935    
Other Study ID Numbers: 00198
First Posted: October 19, 2006    Key Record Dates
Last Update Posted: August 2, 2011
Last Verified: July 2011
Keywords provided by Northport Veterans Affairs Medical Center:
Gastrointestinal Bleeding
Arteriovenous Malformation
Angiodysplasia
Hereditary Hemorrhagic Telangiectasia
Obscure Bleeding
Additional relevant MeSH terms:
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Hemangioma
Gastrointestinal Hemorrhage
Telangiectasis
Arteriovenous Malformations
Telangiectasia, Hereditary Hemorrhagic
Congenital Abnormalities
Hemorrhage
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Malformations
Cardiovascular Abnormalities
Neoplasms, Vascular Tissue
 Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Hemorrhagic Disorders
Hematologic Diseases
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances