Sickle Cell Anemia (HbSS, or HbSß-thalassemia0) Clinical Trial
Official title:
Phase 2 Study of Montelukast for the Treatment of Sickle Cell Anemia (Also Known as the Montelukast Trial in Sickle Cell Anemia)
| Verified date | March 2019 |
| Source | Vanderbilt University Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
In this feasibility trial, the investigators will compare participants treated with montelukast and hydroxyurea to those treated with placebo and hydroxyurea for a total of 8 weeks.
| Status | Completed |
| Enrollment | 46 |
| Est. completion date | March 2018 |
| Est. primary completion date | March 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - 1)Diagnosis of HbSS, or HbSĂ-thalassemia0, confirmed by hemoglobin analysis - 2)Males and females age 16 years to 70 years old - 3)Greater than 2 episodes of pain in the last 12 months - 4)On a stable dose of hydroxyurea for at least 2 months and a stable hemoglobin Exclusion Criteria: 1. Judged not likely to be study compliant by his/her hematologist 2. History of adverse reaction to montelukast or any of the components of montelukast 3. Have used medications known to interact with montelukast such as rifampin, phenobarbital, and gemfibrozil within 4 weeks of enrollment 4. Currently being treated with a leukotriene antagonist (montelukast or zileuton) or have used montelukast/zileuton within the last 60 days 5. Chronic blood transfusion therapy defined as regularly scheduled transfusions. 6. Hemoglobin A greater than15% on hemoglobin analysis 7. Individuals with a current physician diagnosis of asthma (within last 12 months) or requires continuous supplemental oxygen, or predicted or current use of asthma medications (inhaled corticosteroids, but participants taking bronchodilators will be allowed to participate). 8. Current participation in another therapeutic trial for SCD 9. Known current pregnancy 10. Known history of HIV 11. Serum creatinine greater than 3 times the site's upper limit of normal |
| Country | Name | City | State |
|---|---|---|---|
| United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| Lead Sponsor | Collaborator |
|---|---|
| Vanderbilt University Medical Center | Blood Center of Wisconsin, Medical College of Wisconsin |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Soluble Vascular Cell Adhesion Molecule-1 (sVCAM) | The primary outcome measure is based on a 30% reduction, which would be ~106 ng/ml reduction. The study was designed with 25 in each group in order to explore all three aims and potential confounders. However, if the investigators are not able to accrue 25 subjects in each arm, the investigators would still be able to detect a 30% difference in sVCAM with 17 subjects in each group. The 95% confidence interval for detecting a 30% difference is between 204 ng/ml and 290 ng/ml (or an 18-42% reduction in sVCAM). Importantly, the lower limit of the 95% confidence interval (18%) is still a clinically relevant reduction in sVCAM. Thus, if the investigators detect a 30% or larger difference in sVCAM in this study, the investigators will be assured that, based on the 95% confidence interval, these data are clinically important. | baseline to eight weeks |