Condition or disease | Intervention/treatment |
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Sickle Cell Disease | Drug: Voxelotor |
The purpose of this program is to provide early access to voxelotor for patients with sickle cell disease who have exhausted alternative treatment options and are ineligible for actively-recruiting clinical trials of voxelotor.
This EAP may continue until such time that voxelotor is commercially available or the Sponsor discontinues the voxelotor EAP. Discontinuation may occur earlier if an individual participant or physician or Sponsor Medical Monitor decides to discontinue treatment.
Study Type : | Expanded Access |
Expanded Access Type : | Individual Patients |
See clinical trials of the intervention/treatment in this expanded access record. | |
Official Title: | An Open-Label, Expanded Access Protocol for Patient With Sickle Cell Disease Who Have No Alternative Treatment Options |
Tracking Information | ||||
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First Submitted Date | May 7, 2019 | |||
First Posted Date | May 9, 2019 | |||
Last Update Posted Date | December 19, 2019 | |||
Descriptive Information | ||||
Brief Title | Expanded Access to Voxelotor for Patients With Sickle Cell Disease Who Have No Alternative Treatment Options | |||
Official Title | An Open-Label, Expanded Access Protocol for Patient With Sickle Cell Disease Who Have No Alternative Treatment Options | |||
Brief Summary | The intent of this open-label, multicenter expanded access program (EAP) is to provide early access to voxelotor prior to market authorization | |||
Detailed Description |
The purpose of this program is to provide early access to voxelotor for patients with sickle cell disease who have exhausted alternative treatment options and are ineligible for actively-recruiting clinical trials of voxelotor. This EAP may continue until such time that voxelotor is commercially available or the Sponsor discontinues the voxelotor EAP. Discontinuation may occur earlier if an individual participant or physician or Sponsor Medical Monitor decides to discontinue treatment. |
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Study Type | Expanded Access | |||
Expanded Access Type | Individual Patients | |||
Condition | Sickle Cell Disease | |||
Intervention | Drug: Voxelotor
Other Name: GBT440
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Publications * | Not Provided | |||
* 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 | Approved for marketing | |||
Eligibility Criteria |
Inclusion Criteria
Exclusion Criteria
The Sponsor Medical Monitor makes the sole and final enrollment determination for any patient. |
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Sex/Gender |
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Ages | 12 Years and older (Child, Adult, Older Adult) | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT03943615 | |||
Other Study ID Numbers | GBT440-037 | |||
Responsible Party | Global Blood Therapeutics | |||
Study Sponsor | Global Blood Therapeutics | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Global Blood Therapeutics | |||
Verification Date | December 2019 |