Status:
TERMINATED
TRF-1101 Assessment in Sickle Cell Disease
Lead Sponsor:
TRF Pharma, Inc
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study is designed to assess the safety, tolerability, and activity of TRF-1101 on microvascular blood flow, vascular endothelial injury, and vasoocclusive pain associated with sickle cell disease...
Eligibility Criteria
Inclusion
- Be 18 years of age or older at the time of informed consent;
- Have a diagnosis of homozygous sickle cell anemia or sickle cell-beta° thalassemia;
- Have had 2 - 10 documented pain crises in the past year (pain crises are defined as visits to a medical clinic, Emergency Department or hospital, being bedridden and requiring constant analgesia at home for at least three days, or having a three-day interruption of life's activities \[i.e., school, work, planned leisure activity\] because of pain);
- If female and of child bearing potential, have a negative serum or urine pregnancy test and be using an effective birth-control method with a history of reliability for the individual patient (use of mifepristone is not allowed);
- Be properly informed of the nature and risks of the clinical investigation, be willing and able to comply with all clinical investigation-related procedures and assessments, and sign an Institutional Review Board (IRB) approved Informed Consent Form prior to entering the clinical investigation.
Exclusion
- Have a history of abnormal bleeding, stroke, moya moya vascular malformations, or any other contraindication to anticoagulation;
- Be currently taking anticoagulant or thrombolytic medication;
- Be currently taking an endothelin receptor antagonist, e.g., bosentan (Tracleer®);
- Have a known sensitivity or allergy to heparin or related drugs;
- Have a history of thrombocytopenia (platelet count \< 100 x 103/mm3) induced by heparin or related drugs;
- Have had fewer than 2 documented pain crises in the past year;
- Have had a pain crisis within one month of screening or randomization;
- If currently on or recently discontinued hydroxyurea treatment, have initiated or discontinued treatment or changed regimen within the past 6 months;
- Have had a transfusion within last 120 days or have HbA% \> 15% from prior transfusion;
- Creatinine levels \> 1.53 mg/dL (135 umol/L);
- ALT levels ≥ 3 times normal;
- Platelet count \< 100 x 103/mm3;
- INR \> 2.0;
- Be unable to tolerate oral medications;
- Have unreliable venous access;
- Be noncompliant with regular care;
- Have a positive pregnancy test, be currently lactating, or be trying to become pregnant;
- Have participation in an investigational drug or medical device study within previous 30 days;
- Have any other condition or circumstance that in the opinion of the Investigator makes the patient a poor candidate for participation in the study.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00773890
Start Date
July 1 2008
End Date
May 1 2009
Last Update
May 11 2009
Active Locations (6)
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1
Howard University
Washington D.C., District of Columbia, United States, 20060
2
Medical College of Georgia
Augusta, Georgia, United States, 30912
3
University of Illinios Medical Center
Chicago, Illinois, United States, 60612
4
Boston Medical Center
Boston, Massachusetts, United States, 02118