Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding (TAG)

This study has been completed.
Sponsor:
Collaborators:
Georgia Regents University
University of Massachusetts, Worcester
Information provided by:
Northport Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00389935
First received: October 17, 2006
Last updated: August 1, 2011
Last verified: July 2011

October 17, 2006
August 1, 2011
October 2006
June 2011   (final data collection date for primary outcome measure)
Blood Transfusion requirements [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00389935 on ClinicalTrials.gov Archive Site
Hemoglobin overall complication rate Constipation Neuropathy [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding
Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding

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

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Arteriovenous Malformation
  • Hereditary Hemorrhagic Telangiectasia
  • Hematochezia
  • Melena
Drug: Thalidomide
Thalidomide 50 - 200 mg once at nightime
Experimental: Treatment
Intervention: Drug: Thalidomide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
July 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00389935
00198
Yes
Atul Kumar, US Veterans Affairs Medical Center Northport
Northport Veterans Affairs Medical Center
  • Georgia Regents University
  • University of Massachusetts, Worcester
Principal Investigator: Atul Kumar, MD Northport VAMC
Principal Investigator: James Gossage, MD Georgia Regents University
Northport Veterans Affairs Medical Center
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP