A Study to Evaluate the Safety and Efficacy of Crizanlizumab in Sickle Cell Disease Related Priapism (SPARTAN)
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|ClinicalTrials.gov Identifier: NCT03938454|
Recruitment Status : Not yet recruiting
First Posted : May 6, 2019
Last Update Posted : May 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Priapism||Drug: crizanlizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Estimated Study Start Date :||September 2, 2019|
|Estimated Primary Completion Date :||May 21, 2021|
|Estimated Study Completion Date :||March 4, 2022|
5 mg/kg by intravenous infusion at Week 1 Day 1, Week 3 Day 1 and Day 1 of every 4-week cycle until Week 51
Crizanlizumab is a concentrate for solution for infusion, i.v. use. Supplied in single use 10 mL vials at a concentration of 10 mg/mL. One vial contains 100 mg of crizanlizumab
Other Name: SEG101
- Percent change in priapic events from baseline to 26 weeks [ Time Frame: Baseline up to 26 weeks ]Priapism is defined as an unwanted or painful penile erection lasting at least 60 minutes. The end of the priapic event will be the duration when the unwanted erection has resolved. This event will be self-reported via an electronic reporting system, and this data should be collected throughout the study period.
- Rate of priapic events [ Time Frame: Baseline up to 26 and 52 weeks ]The rate of priapic events is defined as the total number of priapic events for a subject occurring from the date of initial infusion to the last contact date of the Treatment Phase
- Percent change in acute priapic events from baseline to 26 weeks [ Time Frame: Baseline up to 26 and 52 weeks ]An acute priapic event is defined as an unwanted, painful erection that lasts more than 4 hours and need a visit to emergency room.
- Rate of uncomplicated vaso-occlusive crises [ Time Frame: Baseline up to 26 and 52 weeks ]The number of uncomplicated VOC events (defined as an acute event of pain with no known cause for pain other than a vaso occlusive event; and requiring treatment with a parenteral or oral opioids or other parenteral analgesic; but is NOT classified as an acute chest syndrome, hepatic sequestration, splenic sequestration or priapism). Events include both healthcare and self-reported events.
- Rate of complicated vaso-occlusive crises [ Time Frame: Baseline up to 26 and 52 weeks ]The number of complicated VOCs (defined as acute chest syndrome, hepatic sequestration, splenic sequestration, and acute priapism) recorded by healthcare visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03938454
|Contact: Novartis Pharmaceuticalsfirstname.lastname@example.org|
|Contact: Novartis Pharmaceuticals|