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Expanded Access to Elezanumab

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: NCT04278235
Expanded Access Status : Available
First Posted : February 20, 2020
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Elezanumab prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Condition or disease Intervention/treatment
Acute Spinal Cord Injury (SCI) Acute Ischemic Stroke Drug: Elezanumab

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Study Type : Expanded Access
Expanded Access Type : Individual Patients, Intermediate-size Population
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Expanded Access to Elezanumab

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Elezanumab
    Solution for intravenous (IV) infusion
    Other Name: ABT-555

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- The participant must not be eligible for an elezanumab clinical trial.


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): NCT04278235


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
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United States, Illinois
Shirley Ryan Ability Lab /ID# 218828 Available
Chicago, Illinois, United States, 60611-3167
NorthShore University HealthSystem - Evanston Hospital /ID# 218255 Available
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04278235    
Other Study ID Numbers: C20-203
C20-284 ( Other Grant/Funding Number: AbbVie )
C20-285 ( Other Grant/Funding Number: AbbVie )
First Posted: February 20, 2020    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
Keywords provided by AbbVie:
Expanded Access
Pre-approval Access
Compassionate Use
Special Access Program
Named Patient Basis
Special Access Scheme
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries