MAP to Provide Access to Crizanlizumab, for Sickle Cell Disease Patients
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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: NCT03720626 |
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Expanded Access Status :
Available
First Posted : October 25, 2018
Last Update Posted : December 23, 2022
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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| Tracking Information | |||||||||
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| First Submitted Date | October 24, 2018 | ||||||||
| First Posted Date | October 25, 2018 | ||||||||
| Last Update Posted Date | December 23, 2022 | ||||||||
| Descriptive Information | |||||||||
| Brief Title | MAP to Provide Access to Crizanlizumab, for Sickle Cell Disease Patients | ||||||||
| Brief Summary | The purpose of this Cohort Treatment Plan is to allow access to crizanlizumab (SEG101) for eligible patients diagnosed with sickle cell disease (SCD) to prevent or reduce the frequency of vaso-occlusive crises (VOC). The patient's Treating Physician should follow the suggested treatment guidelines and comply with all local health authority regulations. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type | Expanded Access | ||||||||
| Expanded Access Type | Treatment IND/Protocol | ||||||||
| Intervention | Drug: crizanlizumab
IV formulation with 30 min infusion, 5mg/kg dosage
Other Name: SEG101
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Expanded Access Status | Available | ||||||||
| Contacts |
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| Listed Location Countries | Not Provided | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03720626 | ||||||||
| Current Responsible Party | Novartis ( Novartis Pharmaceuticals ) | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor | Novartis Pharmaceuticals | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | Novartis | ||||||||
| Verification Date | December 2022 | ||||||||