Actively Recruiting
Protein A immuNoaDsorption for the Treatment of Acute Episodes of Neuromyelitis Optica Spectrum Disorder
Led by Third Affiliated Hospital, Sun Yat-Sen University · Updated on 2025-04-30
144
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
Sponsors
T
Third Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor
S
Second Affiliated Hospital of Guangzhou Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
To clarify the efficacy and safety of protein A immunoadsorption therapy for acute exacerbations of neuromyelitis optica spectrum disorders(NMOSD), we designed a multicenter, open-label, superiority randomized controlled clinical trial, planning to enroll 144 patients with NMOSD. We plan to treat patients with acute NMOSD using protein A immunoadsorption combined with high-dose intravenous methylprednisolone, and compare this with treatment using high-dose intravenous methylprednisolone alone. The aim is to observe the impact and safety of protein A immunoadsorption on the treatment efficacy for these patients experiencing acute exacerbations of NMOSD, ultimately providing more comprehensive clinical evidence to support treatment protocols for the acute phase of NMOSD.
CONDITIONS
Official Title
Protein A immuNoaDsorption for the Treatment of Acute Episodes of Neuromyelitis Optica Spectrum Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of acute Neuromyelitis Optica Spectrum Disorders (NMOSD)
- Age between 18 and 65 years, any gender
- Positive test for AQP4-IgG by cell-based assay (CBA) method
- Ability to understand the study purpose, comply with the protocol, and provide informed consent
You will not qualify if you...
- Women who are pregnant or breastfeeding
- Unable to establish peripheral or central venous access or history of allergic reactions to plasmapheresis
- Contraindications to intravenous methylprednisolone treatment
- Use of monoclonal antibodies in the last 6 months or FcRn antagonists in the last 3 months
- Need to use ACE inhibitors within 1 week before or during the study and unable to discontinue
- Severe bleeding or bleeding disorders
- Severe heart failure
- Severe infections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 518000
Actively Recruiting
Research Team
W
Wei Qiu, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here