Sickle Cell Disease (STAND)
A Phase III, Multicenter, Randomized, Double-blind Study to Assess Efficacy and Safety of Two Doses of Crizanlizumab Versus Placebo, With or Without Hydroxyurea/ Hydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients With Vaso-Occlusive Crises (STAND).
|This Study Is Recruiting: Phase III||Actual Start Date: [April 29, 2019]||Estimated Completion Date: [September 7, 2027]||Novartis Reference Number: CSEG101A2301|
|Condition: Sickle Cell Disease||Interventions: Crizanlizumab, placebo||Estimated Enrollment: [240 participants]||ClinicalTrials.gov Identifier: NCT03814746|
|This Study Is Recruiting: Phase III||Actual Start Date: [April 29, 2019]|
|Estimated Completion Date: [September 7, 2027]||Novartis Reference Number: CSEG101A2301|
|Condition: Sickle Cell Disease||Interventions: Crizanlizumab, placebo|
|Estimated Enrollment: [240 participants]||ClinicalTrials.gov Identifier: NCT03814746|
The purpose of this study is to compare the efficacy and safety of 2 doses of crizanlizumab (5.0 mg/kg and 7.5 mg/kg) versus placebo in adolescent and adult sickle cell disease (SCD) patients with history of vaso-occlusive crisis (VOC) leading to healthcare visit.
Participants may be eligible to participate if they:
- Are ≥ 12 years of age
- Have a confirmed diagnosis of sickle cell disease
- Experienced at least 2 vaso-occlusive crises leading to healthcare visit within the last 12 months prior to screening
- Meet other eligibility
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To view eligibility requirements for this trial, arms and interventions, trial sites and study design, please click to visit this trial on www.clinicaltrials.gov.
Other sickle cell disease trials you might be interested in:
A Phase II, Multicenter, Open-Label Study to Assess Appropriate Dosing and to Evaluate Safety of Crizanlizumab, With or Without Hydroxyurea/Hydroxycarbamide, in Sequential, Descending Age Groups of Pediatric Sickle Cell Disease Patients With Vaso-Occlusive Crisis.
A Prospective Phase II, Open-Label, Single-arm, Multicenter, Study to Assess Efficacy and Safety of SEG101 (Crizanlizumab), in Sickle Cell Disease Patients With Priapism (SPARTAN)
ICF - informed consent form, SCD - sickle cell disease, VOC - vaso-occlusive crisis
Last Updated: July 31, 2019