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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)

Overview

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

Study Goal

The goal of the study is to evaluate the efficacy and safety of crizanlizumab in SCD patients with priapism.

All drugs are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Eligibility

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

If you're interested in this clinical study, your doctor can help evaluate whether you are eligible to participate. Ask your doctor if your medical history or other treatments you're receiving may conflict with the study protocol. If you meet the eligibility criteria and agree to participate in the study: You will be required to sign an informed consent form (ICF). The ICF contains information about the study, which your doctor can help explain to you before you sign. Your doctor will need to complete the necessary tests to see if you are eligible. As with all clinical trials, you have the right to leave the study at any time, for any reason.

Find a Trial Site Location

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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)

Definitions:
ICF - informed consent form, SCD - sickle cell disease

Last Updated: May 6, 2019

7/19 M-GON-1216062