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An Expanded Access Study to Assess Brensocatib for Participants With Non-Cystic Fibrosis Bronchiectasis

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: NCT05344508
Expanded Access Status : Available
First Posted : April 25, 2022
Last Update Posted : January 12, 2023
Sponsor:
Information provided by (Responsible Party):
Insmed Incorporated

Study Description
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Brief Summary:
The purpose of this study is to allow early access to brensocatib for participants with non-cystic fibrosis bronchiectasis (NCFBE) who have successfully completed the INS1007301 ASPEN Clinical trial.

Condition or disease Intervention/treatment
Non-Cystic Fibrosis Bronchiectasis Drug: Brensocatib

Detailed Description:
Participants will receive brensocatib 10 mg, oral tablets, once daily.
Study Design
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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Brensocatib in Patients With Non-Cystic Fibrosis Bronchiectasis

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Drug: Brensocatib
    Brensocatib tablets
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Participant had agreed to provide their informed consent to participate per local requirements.
  • Participant had successfully completed Clinical Trial INS 1007-301 ASPEN, including the End of study Visit 12 prior to receiving treatment.
  • Requests for Post-Trial access for brensocatib had come from ASPEN investigator.
  • Had received brensocatib treatment.

Exclusion Criteria:

  • Participant had experienced a serious adverse event deemed to be related to brensocatib during the study and required permanent participant is continuation.
  • The participant is immunocompromised or chronically treated with any investigational or commercialized immunomodulatory agent that is directed to any component of the adaptive or innate immune systems.

Note: The use of any immunomodulatory agents (including but not limited to: bortezomib, ixazomib, thalidomide, cyclophosphamide, mycophenolate, Janus kinase inhibitors, IFN-γ, and azathioprine) is prohibited during the program.

  • The participant had undergone continuous use of high dose non-steroidal anti-inflammatory drugs.
  • The participant had undergone chronic use of systemic steroids for any chronic condition, except steroids with topical anti-inflammatory activities (ie, oral budesonide).
  • Participant had planned to receive live attenuated vaccines during the program (treatment must be postponed until 4 weeks after the last dose of drug).
  • Participant had planned to use investigational drugs.
Contacts and Locations
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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): NCT05344508


Contacts
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Contact: Insmed Medical Information 1-844-446-7633 medicalinformation@insmed.com

Sponsors and Collaborators
Insmed Incorporated
More Information
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Responsible Party: Insmed Incorporated
ClinicalTrials.gov Identifier: NCT05344508    
Other Study ID Numbers: INS1007-EAP
First Posted: April 25, 2022    Key Record Dates
Last Update Posted: January 12, 2023
Last Verified: January 2023
Keywords provided by Insmed Incorporated:
Cathepsin G
CKD-EPI
NCFBE
Additional relevant MeSH terms:
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Bronchiectasis
Fibrosis
Pathologic Processes
Bronchial Diseases
Respiratory Tract Diseases