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New drug fabhalta under Real-World watch in korea for rare blood and kidney diseases

NCT ID NCT07416162

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is monitoring the safety and effectiveness of the drug iptacopan (Fabhalta) in 21 Korean adults with paroxysmal nocturnal hemoglobinuria (PNH) or C3 glomerulopathy (C3G). Researchers will track side effects and lab results from routine medical records. The goal is to see how well the drug works in everyday clinical practice, not in a controlled trial.

What this could mean

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

Active substance
Iptacopan (Fabhalta)
What this could lead to
If successful, this study could confirm that iptacopan is safe and effective for managing PNH and C3G in real-world Korean patients.
What could go wrong
This is a small, observational post-marketing study with only 21 participants, so results may not apply broadly. It is designed to monitor safety, not to prove a cure.

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.

Participants

About 21 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Feb 2029

An estimate. End dates often move.

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.

Who is studied

Adult patients in South Korea who receive iptacopan for the treatment of PNH or C3G during routine clinical practice.

Ages

18 to 99 years

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: 1. Patients aged 18 years or older who have been diagnosed with PNH or C3G. 2. Patients who have received vaccination in accordance with the approved Korean labeling prior to initiating treatment with iptacopan. 3. Patients who are being treated or will be treated with iptacopan in accordance with the approved Korean labeling. 4. Patients who have voluntarily provided consent for study participation (written informed consent). Exclusion criteria: 1. Patients who fall under the contraindications for iptacopan administration according to approved Korean labeling. 2. Patients for whom iptacopan administration is deemed inappropriate based on the investigator's judgment.

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Conditions

The condition(s) this trial relates to.

complement 3 glomerulopathy Hemoglobinuria, Paroxysmal Hemolysis membranoproliferative glomerulonephritis paroxysmal nocturnal hemoglobinuria proteinuria

As listed by the trial registrant

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

C3 glomerulopathy Paroxysmal nocturnal hemoglobinuria

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Novartis Investigative Site

    RECRUITING

    Jeollanam, 519763, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 03080, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 06591, South Korea

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