NCT06763848Recruiting
Protein A immuNoaDsorption for the Treatment of Acute Episodes of Neuromyelitis Optica Spectrum Disorder
Protein A Immunoadsorption for the Treatment of Acute Episodes of Neuromyelitis Optica Spectrum Disorder：A Multicenter, Open-label, Superiority, Randomised Trial
Source: ClinicalTrials.gov · Last updated 30 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 144 (estimated)
- First submitted
- 15 Dec 2024
- Start date
- 25 Apr 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Diseases
- Neuromyelitis optica (NMOSD)
- NCT number
- NCT06763848
What you commit to
- Study type: Interventional
- Planned participants: 144
- From 25 Apr 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who have used monoclonal antibodies in the last 6 months, or FcRn antagonists in the last 3 months.
- Participants who must use ACE inhibitors (ACEI) within 1 week before the start of treatment or during the study, and cannot discontinue their use.
Other illness
- Participants who cannot establish peripheral or central venous access, or have a history of allergic reactions to plasmapheresis.
- Severe Bleeding or Bleeding Disorders
- Severe Heart Failure
- Severe Infections
Other
- Women who are pregnant or breastfeeding.
- Participants with contraindications to intravenous methylprednisolone treatment.
Who the study is looking for
- The inclusion criteria for the study are as follows:
- clinical diagnosis of acute Neuromyelitis Optica Spectrum Disorders (NMOSD)
- Age and Gender: Participants must be between 18 and 65 years old, inclusive, with no gender restrictions.
- Serological Marker: Participants must test positive for AQP4-IgG using the cell-based assay (CBA) method.
- Understanding and Consent: Participants or their legal representatives must be able to understand the study's purpose, demonstrate sufficient compliance with the study protocol, and sign the informed consent form.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Third Affiliated Hospital of Sun Yat-Sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.