Sickle Cell Disease (SPARTAN)
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)
|This Study Is Recruiting: Phase II||Actual Start Date: [April 1, 2019]||Estimated Completion Date: [March 31, 2021]||Novartis Reference Number: CSEG101AUS05|
|Condition: Sickle Cell Disease||Interventions: Crizanlizumab||Estimated Enrollment: [56 participants]||ClinicalTrials.gov Identifier: NCT03938454|
|This Study Is Recruiting: Phase II||Actual Start Date: [April 1, 2019]|
|Estimated Completion Date: [March 31, 2021]||Novartis Reference Number: CSEG101AUS05|
|Condition: Sickle Cell Disease||Interventions: Crizanlizumab|
|Estimated Enrollment: [56 participants]||ClinicalTrials.gov Identifier: NCT03938454|
The goal of the study is to evaluate the efficacy and safety of crizanlizumab in SCD patients with priapism.
Participants may be eligible to participate if they:
- Are male and ≥16 years of age
- Have a confirmed diagnosis of sickle cell disease
- Experienced at least 4 or more priapic events over the 14-week prescreening period
- Experienced at least 3 priapic events during the 12-week screening period with at least 1 event occurring within 4 weeks prior to first treatment
- 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 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)
ICF - informed consent form, SCD - sickle cell disease
Last Updated: May 6, 2019