Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06151938
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-20
First Post:
2023-11-16
Brief Title:
Evaluate Measurement Instruments Relevance in Assessing Effectiveness of ACARIZAX in House Dust Mite Allergic Rhinitis
Sponsor:
ALK-Abelló AS
Organization:
ALK-Abelló AS
Study Overview
Official Title:
A Prospective Observational Study Evaluating Relevance of Measurement Instruments in Assessing Effectiveness of ACARIZAX in the Treatment of Moderate to Severe House Dust Mite Allergic Rhinitis WithWithout Allergic Asthma in Chinese
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is a single-center observational design with a 12-month duration Approximately 100 Chinese adult 18-65 years old and adolescent 12-17 years old with moderate to severe house dust mite HDM allergic rhinitis AR with or without allergic asthma AA who are newly prescribed ACARIZAX will be recruited for evaluation of the relevance of measurement instruments The instruments referred to three patient-report scales of allergic rhinitis symptom and quality-of-life including the Daily symptom score DSS Standardised rhinoconjunctivitis quality-of-life questionnaire RQLQS and Visual analogue scale VAS Other data will be collected to evaluate the effectiveness and safety of ACARIZAX under real-world clinical practices
Detailed Description:
This is a prospective non-interventional observational single-centre open-label study Chinese adult 18-65 years old and adolescent 12-17 years old HDM AR patients who are newly prescribed with ACARIZAX at the discretion of attending physician according to the approved indication by Hainan Provincial Health Commission will be recruited for this study Approximately 100 adult 18-65 years old and adolescent 12-17 years old patients are expected to be enrolled from Hainan Branch Hospital of Ruijin Hospital Patients are included in the study only after the decision for treatment with ACARIZAX has been made and only with the objective of collecting relevant data about clinical effectiveness and safety of treatment with ACARIZAX under real-world conditions No further medical procedures beyond standard care at the discretion of the attending physician are necessary for participation in this study
Over the 13-month study including 12-month of treatment total of 5 scheduled visits will be documented enrolment and first administration of ACARIZAX Visit 1 V0 and subsequent visits performed in 3-month intervals after the first administration at the third month Visit 2 V1 sixth month Visit 3 V2 ninth month Visit 4 V3 and twelfth month Visit 5 V4 respectively The actual number and duration of follow-up visits are according to routine practice and may be changed at the physicians discretion All adverse events AE will be collected from the first dose administration until 30 days after the last dose of ACARIZAX end of study
Over the 13-month study including 12-month of treatment total of 5 scheduled visits will be documented enrolment and first administration of ACARIZAX Visit 1 V0 and subsequent visits performed in 3-month intervals after the first administration at the third month Visit 2 V1 sixth month Visit 3 V2 ninth month Visit 4 V3 and twelfth month Visit 5 V4 respectively The actual number and duration of follow-up visits are according to routine practice and may be changed at the physicians discretion All adverse events AE will be collected from the first dose administration until 30 days after the last dose of ACARIZAX end of study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None