NCT03028480|CompletedResults
Long Term Special Drug Use Investigation of Mepolizumab
Nucala® Subcutaneous Injection Special Drug Use Investigation (Long-Term)
Loading search results
Nucala® Subcutaneous Injection Special Drug Use Investigation (Long-Term)
Sponsor study identifier
observational
1,061
0 countries
N/A
Study Start
January 11, 2017
Actual (reported)Primary Completion
November 22, 2023
Actual (reported)Study Completion
November 22, 2023
Actual (reported)This study is a special drug use investigation program of NUCALA (a brand name for Mepolizumab) administered subcutaneously (SC). In this study the information regarding the safety and effectiveness of long term use of NUCALA after subcutaneous injection will be collected from Asthma subjects in daily clinical practice. The observation period per subject will be 52 weeks from the initiation of NUCALA treatment with follow-up investigation for 2 years after the observation period. NUCALA is a registered trademark of the GlaxoSmithKline \[GSK\] group of companies
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 22, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 6, 2017
Actual (reported)January 11, 2017
Actual (reported)January 23, 2017
Actual (reported)November 22, 2023
Actual (reported)November 22, 2023
Actual (reported)September 20, 2024
Actual (reported)Number of Participants Whose Data Entered on Electronic Data Capture (EDC) System
The number of participants whose data was entered in the EDC system up to 14 days from the initiation of NUCALA treatment (Day 1) has been presented.
Up to 14 days from the initiation of NUCALA treatment (Day 1)
Percentage of Participants With Adverse Drug Reaction (ADR)
ADR is defined as a response to a drug which is noxious and unintended, and which occurred at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function. Percentage of participants with ADR were calculated as the number of participants having a particular ADR divided by total number of participants on NUCALA treatment\*100. Percentage values are rounded-off.
Up to 3 years
Number of Participants Showing Response to the Treatment
The number of participants who showed response to the bronchial asthma treatment has been presented.
Up to 1 year
Number of Participants Excluded From Analysis Due to Exacerbation of Asthma
The number of participants excluded from analysis due to exacerbation of asthma has been presented.
Up to 1 year
Response Rate Assessed by Global Assessment of Effectiveness
Up to 1 year
Rate of Exacerbation of Asthma
52 weeks before the initiation of NUCALA treatment (Day 1) and at Week 52 post-treatment
Total Score of Asthma Control Test (ACT) at Indicated Time Points
Baseline, Weeks 12, 24 and 52 after the initiation of NUCALA treatment (Day 1)
Mean Peak Expiratory Flow (PEF) at Indicated Time Points
Baseline, Weeks 12, 24 and 52 after the initiation of NUCALA treatment (Day 1)
Subjects with a refractory asthma whose symptoms are inadequately controlled despite receiving standard asthma medications will be enrolled
Single dose of NUCALA SC will be administered. Dose unit, daily dose frequency, date of administration will be at the investigator discretion.
Subjects receiving NUCALA for the first time for treatment of bronchial asthma (a refractory asthma whose symptoms are inadequately controlled despite receiving standard asthma medications)
Contact the study team to confirm eligibility.
GSK Clinical Trials
GlaxoSmithKline
1,061 participants (actual enrollment reported by the registry).
First Submitted
January 6, 2017
First Posted
January 23, 2017
Study Start
January 11, 2017
Actual (reported)A Trial of Mepolizumab Adjunctive Therapy for the Prevention of Asthma Exacerbations in Urban Children
Number of Participants With Adverse Drug Reactions (ADR)
ADR is defined as a response to a drug which is noxious and unintended, and which occurred at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.
Up to 3 years
Percentage of Participants With Occurrences of Safety Specifications and Priority Investigation Matters
Safety specifications and priority investigation matters included hypersensitivity reaction including anaphylaxis, infections, and malignant tumor. The percentage of participants with occurrences of safety specifications and priority investigation matters have been reported. Percentage values are rounded-off.
Up to 3 years
Primary Completion
November 22, 2023
Actual (reported)Study Completion
November 22, 2023
Actual (reported)Last Updated
September 20, 2024
Results First Posted
September 20, 2024
Record last verified: 2024-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: