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FAsenra Safety Trial in India

NCT05384938 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2024-12-11

Study results available
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Summary

Benralizumab is a humanised, afucosylated, monoclonal antibody that binds specifically to the human interlukin-5 (IL-5) receptor alpha subunit (IL-5Rα) of target cells such as eosinophils and basophils (Takatsu et al, 1994; Toba et al, 1999; Pelaia et al, 2020).

Benralizumab was generally well tolerated by patients in clinical trials, with no apparent safety concerns.

This study shall be conducted at 10 centers across India. The primary outcome measures will be

* Percentage of AEs a, SAEs, and TEAEs
* Nature, incidence, and severity of AEs including unexpected adverse drug reactions
* Percentage of patients with AEs that lead to study treatment discontinuations.

Conditions

  • In Adult Patients of Severe Asthma With Eosinophilic Phenotype in India

Interventions

BIOLOGICAL

Benralizumab

Prospective, Single-arm Study to Assess the Safety of Fasenra® (Benralizumab) in Adult Patients of Severe Asthma with Eosinophilic Phenotype in India

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-19
Primary Completion
2023-07-01
Completion
2023-07-01

Countries

  • India

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05384938 on ClinicalTrials.gov