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A Study to Evaluate the Safety and Efficacy of Crizanlizumab in Sickle Cell Disease Related Priapism (SPARTAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03938454
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : January 19, 2023
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
The goal of the study is to evaluate the efficacy and safety of crizanlizumab in SCD patients with priapism.

Condition or disease Intervention/treatment Phase
Priapism Drug: crizanlizumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : October 23, 2019
Estimated Primary Completion Date : January 26, 2023
Estimated Study Completion Date : November 3, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Crizanlizumab
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
 Drug: crizanlizumab
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Male patients aged 16 years and above
  • Confirmed diagnosis of SCD by hemoglobin electrophoresis or high performance liquid chromatography. All SCD genotypes are eligible (HbSS, HbSβ0, HbSC, HbSβ+, and others)
  • Experienced 4 or more priapic events (unwanted erection lasting at least 60 minutes) over the 14 weeks preceding study participation
  • Experienced at least 3 priapic events (unwanted erection lasting at least 60 minutes) during the 12 week screening period with at least 1 event occurring within 4 weeks prior to the first treatment.
  • If receiving hydroxyurea/hydroxycarbamide or L-glutamine or erythropoietin stimulating agent or voxelotor, must have been receiving the drug for at least 14 weeks prior to screening and plan to continue taking the drug at the same dose and schedule during the trial
  • If receiving prophylactic treatment for priapism, must have been receiving the drug for at least 14 weeks prior to screening and plan to continue taking the drug at the same dose and schedule during the trial
  • Written informed consent (or assent/ parental consent for minor subjects) prior to any screening procedures

Exclusion criteria:

  • Had penile prosthetic implants or shunts or any other surgical procedure on the penis performed within 12 months prior to consenting are not allowed
  • Took drugs/medications that may induce priapism over the 14 weeks preceding study entry
  • Received leuprolide acetate (Lupron) within 3 months before pre-screening.
  • Had an erection lasting more than 12 hours over the 14 week preceding study entry
  • Had an erection lasting more than 12 hours during the 12 weeks of the screening period

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 usoncology.medinfo@novartis.com
Contact: Novartis Pharmaceuticals

Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03938454    
Other Study ID Numbers: CSEG101AUS05
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: January 19, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Priapism
sickle cell disease
SCD
crizanlizumab
P-selectin
 SEG101
monoclonal antibody
prolonged erection
painful erection
Additional relevant MeSH terms:
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Priapism
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
 Genetic Diseases, Inborn
Penile Diseases
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Male Urogenital Diseases