Real-World Treatment Study of Soliris (Eculizumab)

NCT06448715 | Completed

• 1 other identifier: D7412R00001
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 2

Brief Summary

As part of a post-approval commitment, the Korean health authority requests a study to characterize safety and effectiveness in patients who are treated with Soliris in normal clinical practice settings. This study is designed to assess the known safety profile or identify previously unsuspected adverse reactions and to evaluate the effectiveness of Soliris under conditions of routine daily medical practice in Korea. This study will provide information on the population of Korean patients who are treated with Soliris.

Conditions

Observational

Outcome Measures

Primary Outcomes (1)

• safety assessment of soliris

  Safety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs), unexpected AEs/ADRs)

  24 weeks

Secondary Outcomes (1)

• efficacy assessment of Soliris

  24 weeks

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

According to the medical judgment of the investigator, patients who received Soliris in accordance with product label will be enrolled if they meet all the inclusion criteria and none of the exclusion criteria.

You may qualify if:

• Patients aged 19 or older with NMOSD positive for anti-aquaporin-4 (AQP-4) antibody who are receiving or starting treatment with Soliris according to the product label
• Patients who have been vaccinated against Neisseria meningitidis at least 2 weeks prior to receiving the first dose of Soliris. However, patients who receive Soliris within 2 weeks after Neisseria meningitidis vaccination should receive treatment with appropriate prophylactic antibiotics for 2 weeks after vaccination
• Patient who understood and consented to the written informed consent provided.

You may not qualify if:

• Patients with hypersensitivity to eculizumab, murine protein, or any other component of Soliris
• Patients with untreated serious Neisseria meningitidis infection.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Research Site

Goyang-si, South Korea

Location

Research Site

Seoul, South Korea

Location

Related Links

• CSR Synopsis

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 7, 2024
• Study Start: May 28, 2024
• Primary Completion: January 3, 2025
• Study Completion: January 3, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

KR (2)