Phase 2
Completed N=46
Phase 2 Study of Montelukast for the Treatment of Sickle Cell Anemia
Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0)
Source: ClinicalTrials.gov NCT01960413 ↗
Enrolled (actual)
46
Serious AEs
13.0%
Results posted
Mar 2019
Primary outcomePrimary: Change in Soluble Vascular Cell Adhesion Molecule-1 (sVCAM) — -3.2; 4.17 ng/mL
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Soluble Vascular Cell Adhesion Molecule-1 (sVCAM) |
-3.2; 4.17 | — |
Eligibility Criteria
Inclusion Criteria
- 1)Diagnosis of HbSS, or HbSβ-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
- Judged not likely to be study compliant by his/her hematologist
- History of adverse reaction to montelukast or any of the components of montelukast
- Have used medications known to interact with montelukast such as rifampin, phenobarbital, and gemfibrozil within 4 weeks of enrollment
- Currently being treated with a leukotriene antagonist (montelukast or zileuton) or have used montelukast/zileuton within the last 60 days
- Chronic blood transfusion therapy defined as regularly scheduled transfusions.
- Hemoglobin A greater than15% on hemoglobin analysis
- 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).
- Current participation in another therapeutic trial for SCD
- Known current pregnancy
- Known history of HIV
- Serum creatinine greater than 3 times the site's upper limit of normal
Data sourced from ClinicalTrials.gov (NCT01960413). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.