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Phase II Study of Arginine Butyrate With or Without Epoetin alfa in Patients With Thalassemia Intermedia Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Phase II Study of Arginine Butyrate With or Without Epoetin alfa in Patients With Thalassemia Intermedia conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Phase II Study of Arginine Butyrate With or Without Epoetin alfa in Patients With Thalassemia Intermedia Clinical research trials and Phase II Study of Arginine Butyrate With or Without Epoetin alfa in Patients With Thalassemia Intermedia health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Phase II Study of Arginine Butyrate With or Without Epoetin alfa in Patients With Thalassemia Intermedia. Phase II Study of Arginine Butyrate With or Without Epoetin alfa in Patients With Thalassemia Intermedia Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Phase II Study of Arginine Butyrate With or Without Epoetin alfa in Patients With Thalassemia Intermedia clinical trial. Subjects frequently get the best healthcare possible for their Phase II Study of Arginine Butyrate With or Without Epoetin alfa in Patients With Thalassemia Intermedia condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase II Study of Arginine Butyrate With or Without Epoetin alfa in Patients With Thalassemia Intermedia  Phase II Study of Arginine Butyrate With or Without Epoetin alfa in Patients With Thalassemia Intermedia
Phase II Study of Arginine Butyrate With or Without Epoetin alfa in Patients With Thalassemia Intermedia
For Condition: beta-Thalassemia
Status: Recruiting
Sponsor(s): Boston University School of Medicine ,
Synopsis: OBJECTIVES: I. Determine whether arginine butyrate with or without epoetin alfa can stimulate gammaglobin 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 gammaglobin 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.
Details: PROTOCOL OUTLINE: This is a multicenter study. Patients receive arginine butyrate IV over 6-14 hours on days 1-5 of weeks 1-4 and 7-10. Patients then receive maintenance arginine butyrate IV over 6-14 hours on days 1-4 of weeks 13, 15, 17, 19, 21, 23, and 25. Patients who have no medical contraindications (e.g., paraspinal extramedullary hematopoiesis, hypertension, or poorly controlled congestive heart failure) may continue therapy. Patients receive arginine butyrate IV over 6-14 hours on days 1-4 of weeks 27, 29, 31, 33, 35, 37, and 39 and epoetin alfa intramuscularly (IM) or subcutaneously (SC) three times weekly on weeks 27-40. Patients may continue to receive epoetin alfa IM or SC alone three times weekly on weeks 41-52. Patients with severe anemia (hemoglobin less than 7 g/dL) may receive epoetin alfa alone on weeks 1-12 before arginine butyrate induction therapy. Patients who complete therapy at week 26 are followed every 2 weeks for 2 months. Patients who complete therapy at week 40 are followed monthly for 2 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 3 Years/
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of thalassemia intermedia with hemoglobin no greater than 10 g/dL Two beta thalassemia mutations - Must have undergone prior splenectomy or have no palpable spleen --Prior/Concurrent Therapy-- - At least 3 months since prior red blood cell transfusion --Patient Characteristics-- - Performance status: SWOG 0-2 - Hematopoietic: No severe iron overload or ferritin greater than 5,000 ng/mL - Hepatic: Normal hepatic function No active hepatitis - Renal: Normal renal function - Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Must be willing to have vascular access placed No viral disease No contraindication to study compliance
Total Enrollment: 15
Location and Contact Information:
Overall Study Official:
SusanPerrine, Study Chair, Boston University School of Medicine
Boston University School of Medicine *Recruiting*
Boston, Massachusetts, 02118
United States
Recruiting Susan Perrine 617-638-4173
Cancer Research Center *Recruiting*
Boston, Massachusetts, 02118
United States
Recruiting Douglas Faller 617-638-4173
Yale Comprehensive Cancer Center *Recruiting*
New Haven, Connecticut, 06520-8028
United States
Recruiting Howard Pearson 203-785-4638
Clinical Hematology Branch *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Griffin Rodgers 301-402-2418
Mount Sinai School of Medicine *Recruiting*
New York City, New York, 10029
United States
Recruiting George Atweh 212-785-6662
University College London *Recruiting*
London, England, W1W 7EJ
United Kingdom
Recruiting John Porter 171-209-6224
Children's Hospital of Oakland *Recruiting*
Oakland, California, 94609
United States
Recruiting Elliott Vichinsky 415-428-3651
Additional Information:
Study ID Numbers: 199/15337; BUSM-4839
Study Start Date: March 1999
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006136
Other Beta-Thalassemia Studies:
1. Phase II Study of Arginine Butyrate With or Without Epoetin alfa in Patients With Thalassemia Intermedia
2. Safety & Efficacy of ICL670 vs. deferoxamine in Beta-thalassemia patients with iron overload due to blood transfusions
3. Study of ICL670 in iron overload from beta-thalassemia unable to be treated with deferoxamine or chronic anemias
4. Iron Balance Study of DFO and GT56-252 in Patients with Transfusional Iron Overload Secondary to Beta-Thalassemia
5. Thalassemia (Cooley's Anemia) Clinical Research Network (TCRN)
Related Studies:
Other beta-Thalassemia Clinical Trials
Other Massachusetts Clinical Trials
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Phase II Study of Arginine Butyrate With or Without Epoetin alfa in Patients With Thalassemia Intermedia
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