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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00389935
Date of registration: 17/10/2006
Prospective Registration: Yes
Primary sponsor: Northport Veterans Affairs Medical Center
Public title: Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding TAG
Scientific title: Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding
Date of first enrolment: October 2006
Target sample size: 14
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00389935
Study type:  Interventional
Study design:  Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     James Gossage, MD
Address: 
Telephone:
Email:
Affiliation:  Georgia Regents University
Name:     Atul Kumar, MD
Address: 
Telephone:
Email:
Affiliation:  Northport VAMC
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Arteriovenous Malformation
Hematochezia
Hereditary Hemorrhagic Telangiectasia
Melena
Intervention(s)
Drug: Thalidomide
Primary Outcome(s)
Blood Transfusion requirements [Time Frame: 6 months]
Secondary Outcome(s)
Hemoglobin overall complication rate Constipation Neuropathy [Time Frame: 6 month]
Secondary ID(s)
00198
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Georgia Regents University
University of Massachusetts, Worcester
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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