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FASENRA SCEI for Long-term Use

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ClinicalTrials.gov Identifier: NCT03588546
Recruitment Status : Recruiting
First Posted : July 17, 2018
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date May 25, 2018
First Posted Date July 17, 2018
Last Update Posted Date October 9, 2019
Actual Study Start Date May 31, 2018
Estimated Primary Completion Date April 30, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 4, 2018)
Incidences of adverse drug reactions (ADRs) [all ADRS, unexpected ADRs and key investigational safety specification (serious infection)] [ Time Frame: 1 year ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03588546 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 4, 2018)
Change scores from baseline in Asthma Control Questionnaire (ACQ) with exploring a factor to affect them by patient's background and treatment condition [ Time Frame: 1 year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title FASENRA SCEI for Long-term Use
Official Title FASENRA Subcutaneous Injection 30 mg Syringe Specific Clinical Experience Investigation for Long-term Use
Brief Summary The purpose of the investigation is to confirm the safety and efficacy under the post-marketing actual long-term use of FASENRA Subcutaneous Injection 30 mg Syringe.
Detailed Description

The purpose of the investigation is to confirm the followings under the post-marketing actual long-term use of FASENRA Subcutaneous Injection 30 mg Syringe.

  1. Detection of unexpected Adverse Drug Reactions
  2. To grasp development of Adverse Drug Reactions
  3. To grasp contributing factors possibly having an impact on the safety and efficacy
  4. Development of key investigational safety specification (serious infection).
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The patients treated with Fasenra for the first time due to "Bronchial asthma (only the patients with intractable bronchial asthma which could not be controlled with the existing therapy).
Condition Asthma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 4, 2018)
780
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 30, 2025
Estimated Primary Completion Date April 30, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

-The evaluable patients treated with Fasenra for the first time due to "Bronchial asthma (only the patients with intractable bronchial asthma which could not be controlled with the existing therapy).

Exclusion Criteria:

-No past history of hypersensitivity to the components of Fasenra.

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03588546
Other Study ID Numbers D3250C00057
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party AstraZeneca
Study Sponsor AstraZeneca
Collaborators Not Provided
Investigators
Study Director: Toshimitsu Tokimoto AstraZeneca KK
PRS Account AstraZeneca
Verification Date October 2019