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Dupilumab Compassionate Use Study

Expanded access is currently available for this treatment.
Verified June 2017 by Sally E. Wenzel MD, University of Pittsburgh
Sponsor:
ClinicalTrials.gov Identifier:
NCT03020810
First Posted: January 13, 2017
Last Update Posted: June 27, 2017
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.
Information provided by (Responsible Party):
Sally E. Wenzel MD, University of Pittsburgh
  Purpose
This is a single patient expanded access, compassionate and non-emergency use study that provides patients with severe asthma, who do not qualify for ongoing clinical trials with dupilumab, access to this investigational treatment.

Condition Intervention
Asthma Drug: Dupilumab

Study Type: Expanded Access     What is Expanded Access?
Official Title: Dupilumab Compassionate Use Study

Resource links provided by NLM:


Further study details as provided by Sally E. Wenzel MD, University of Pittsburgh:

Intervention Details:
    Drug: Dupilumab
    The patient will receive a 600 mg subcutaneous dupilumab loading dose on Day 1, and then 300 mg subcutaneous dupilumab every 2 weeks
Detailed Description:

This study is being undertaken to determine whether dupilumab has efficacy in extremely severe asthma, and to allow a very severe asthma patient, who has been tried on nearly every immunosuppressive drug, early access to a potentially effective therapy.

The patient will continue in the study indefinitely. Safety will be evaluated and serious adverse events will be reported.

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Sever systemic corticosteroid dependent asthma for more than 5 years

Exclusion Criteria:

  • Disease other than asthma
  • Circulation eosinophils more than 1500/ul
  • Current smoker or more than 10 pack years

This is a single-patient study. The University of Pittsburgh site is not enrolling new patients.

  Contacts and Locations
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): NCT03020810


Contacts
Contact: Catherine Vitari, RN BSN AE-C 4126479955 vitarica@upmc.edu

Sponsors and Collaborators
Sally E. Wenzel MD
  More Information

Responsible Party: Sally E. Wenzel MD, Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03020810     History of Changes
Other Study ID Numbers: PRO16120334
First Submitted: January 11, 2017
First Posted: January 13, 2017
Last Update Posted: June 27, 2017
Last Verified: June 2017