Phase II Study of Arginine Butyrate With or Without Epoetin Alfa in Patients With Thalassemia Intermedia
Completed · Phase 2
Conditions studied: Beta-Thalassemia
In brief
OBJECTIVES: I. Determine whether arginine butyrate with or without epoetin alfa can stimulate gamma-globin chain production to a degree that decreases anemia and results in hematologic improvement in patients with thalassemia intermedia. II. Determine whether a proportional increase in gamma-globin synthesis and mRNA and an improvement in nonalfa and alfaglobin chain imbalance by at least 10% over baseline correlate with improved hematologic response in these patients when treated with this regimen. III. Determine whether a decrease in hemolysis, as assayed by a decrease in LDH, compared to baseline levels correlates with improved hematologic response in these patients when treated with this regimen. IV. Determine whether any particular genotypes are more responsive than others to this therapy in these patients. V. Determine whether baseline epoetin alfa levels, gender, and/or baseline reticulocyte counts (or percent circulating nucleated erythroblasts) correlate with improved hematologic response in these patients when treated with this regimen.
Key facts
- Study ID
- NCT00006136
- Run by
- Boston University
- People needed
- 15
- Starts
- 1999-03-01
- Last updated by the study team
- 2005-11-08
Who can join
Age: 3 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Children's Hospital of Oakland — Oakland, California, United States
- Yale Comprehensive Cancer Center — New Haven, Connecticut, United States
- Clinical Hematology Branch — Bethesda, Maryland, United States
- Boston University School of Medicine — Boston, Massachusetts, United States
- Cancer Research Center — Boston, Massachusetts, United States
- Mount Sinai School of Medicine — New York, New York, United States
- University College London — London, England, United Kingdom
Full record on ClinicalTrials.gov
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