NCT03744546

Brief Summary

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to ABBV-8E12 prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. 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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 16, 2018

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

First QC Date

November 14, 2018

Last Update Submit

August 16, 2019

Conditions

Keywords

Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme.

Interventions

Solution for infusion

Sponsors & Collaborators

MeSH Terms

Interventions

tilavonemab

Study Officials

  • AbbVie Inc.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2018

First Posted

November 16, 2018

Last Updated

August 20, 2019

Record last verified: 2019-08