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New hope for PNH patients in china: eculizumab shows promise

NCT ID NCT05886244

Disease control Sponsor: Alexion Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested eculizumab in 25 adults with PNH in China who had not previously taken complement inhibitors. Participants received infusions over 62 weeks. The main goal was to see if the drug reduced LDH levels, a marker of disease activity. Results showed a decrease in LDH, suggesting the drug helped control the disease. Safety was also monitored, with no new concerns beyond known risks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
eculizumab
What this could lead to
If successful, this could provide a treatment option for people with PNH in China, helping control the disease and reduce symptoms.
What could go wrong
This is a small, single-arm study with only 25 participants, so results may not apply broadly. Eculizumab requires lifelong treatment and carries a risk of serious meningococcal infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

25 people

The number who actually took part.

Started

Jul 2023

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult C5 inhibitor naïve PNH patients (age\>=18), which is confirmed by flow cytometry evaluation * Must be vaccinated against N meningitidis Exclusion Criteria: * Meningitidis infection or unresolved meningococcal disease * Significant bone marrow failure * Other significant systemic diseases that might have impact on efficacy and safety assessment

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Conditions

The condition(s) this trial relates to.

Hemoglobinuria, Paroxysmal paroxysmal nocturnal hemoglobinuria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Paroxysmal nocturnal hemoglobinuria

Contacts and locations

Locations

  • Research Site

    Beijing, CN-100730, China

  • Research Site

    Hangzhou, 310003, China

  • Research Site

    Nantong, 226001, China

  • Research Site

    Shanghai, 200040, China

  • Research Site

    Tianjin, 300020, China

  • Research Site

    Tianjin, 300050, China

  • Research Site

    Wuhan, 430022, China

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