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New drug fabhalta under safety watch for rare blood disorder

NCT ID NCT06606314

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 11, 2026 · Updated 4 times

Summary

This study tracks 132 people with PNH who are taking Fabhalta to see how safe it is and what side effects occur. Researchers will monitor infections and check for serious red blood cell breakdown if the drug is stopped. The goal is to better understand the drug's risks in everyday use.

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

132 people

The number who actually took part.

Started

Sep 2024

Expected to finish

Sep 2028

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

All patients who received Fabhalta.

Ages

0 to 100 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: All patients who received Fabhalta. · Exclusion Criteria: Patients receiving Fabhalta for an unapproved indication under the Clinical Trials Act or GCP.

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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

  • Novartis Investigative Site

    Handa, Aichi-ken, 4750817, Japan

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4538511, Japan

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4668650, Japan

  • Novartis Investigative Site

    Okazaki, Aichi-ken, 4448553, Japan

  • Novartis Investigative Site

    Toyohashi, Aichi-ken, 4418570, Japan

  • Novartis Investigative Site

    Toyota, Aichi-ken, 4700343, Japan

  • Novartis Investigative Site

    Toyota, Aichi-ken, 4718513, Japan

  • Novartis Investigative Site

    Hachinohe, Aomori, 0391104, Japan

  • Novartis Investigative Site

    Chiba, Chiba, 2608677, Japan

  • Novartis Investigative Site

    Funabashi, Chiba, 2738556, Japan

  • Novartis Investigative Site

    Kashiwa, Chiba, 2778567, Japan

  • Novartis Investigative Site

    Narita, Chiba, 2868523, Japan

  • Novartis Investigative Site

    Matsuyama, Ehime, 7908524, Japan

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 8108563, Japan

  • Novartis Investigative Site

    Kurume, Fukuoka, 8308543, Japan

  • Novartis Investigative Site

    Aizu-Wakamatsu, Fukushima, 9693482, Japan

  • Novartis Investigative Site

    Kohriyama, Fukushima, 9638022, Japan

  • Novartis Investigative Site

    Maebashi, Gunma, 3710811, Japan

  • Novartis Investigative Site

    Fukuyama, Hiroshima, 7200001, Japan

  • Novartis Investigative Site

    Hakodate, Hokkaido, 0418680, Japan

  • Novartis Investigative Site

    Sapporo, Hokkaido, 0030006, Japan

  • Novartis Investigative Site

    Sapporo, Hokkaido, 0640804, Japan

  • Novartis Investigative Site

    Amagasaki, Hyōgo, 6608511, Japan

  • Novartis Investigative Site

    Ashiya, Hyōgo, 6590012, Japan

  • Novartis Investigative Site

    Himeji, Hyōgo, 6708540, Japan

  • Novartis Investigative Site

    Kobe, Hyōgo, 6500047, Japan

  • Novartis Investigative Site

    Kobe, Hyōgo, 6510072, Japan

  • Novartis Investigative Site

    Nishinomiya, Hyōgo, 663-8241, Japan

  • Novartis Investigative Site

    Nishinomiya, Hyōgo, 6638501, Japan

  • Novartis Investigative Site

    Tsukuba, Ibaraki, 3002622, Japan

  • Novartis Investigative Site

    Tsukuba, Ibaraki, 3004321, Japan

  • Novartis Investigative Site

    Tsukuba, Ibaraki, 3058576, Japan

  • Novartis Investigative Site

    Morioka, Iwate, 0200066, Japan

  • Novartis Investigative Site

    Sakaidechō, Kagawa-ken, 7628550, Japan

  • Novartis Investigative Site

    Kanoya, Kagoshima-ken, 8930024, Japan

  • Novartis Investigative Site

    Isehara, Kanagawa, 2591193, Japan

  • Novartis Investigative Site

    Yokohama, Kanagawa, 2320024, Japan

  • Novartis Investigative Site

    Kumamoto, Kumamoto, 8608556, Japan

  • Novartis Investigative Site

    Kyoto, Kyoto, 6038151, Japan

  • Novartis Investigative Site

    Uji, Kyoto, 6110042, Japan

  • Novartis Investigative Site

    Ōsaki, Miyagi, 9896183, Japan

  • Novartis Investigative Site

    Miyazaki, Miyazaki, 8808510, Japan

  • Novartis Investigative Site

    Nobeoka, Miyazaki, 8820835, Japan

  • Novartis Investigative Site

    Matsumoto, Nagano, 3908621, Japan

  • Novartis Investigative Site

    Nagano, Nagano, 3808582, Japan

  • Novartis Investigative Site

    Suwa, Nagano, 3928510, Japan

  • Novartis Investigative Site

    Ōmura, Nagasaki, 8568562, Japan

  • Novartis Investigative Site

    Ikoma, Nara, 6300293, Japan

  • Novartis Investigative Site

    Nagaoka, Niigata, 9402085, Japan

  • Novartis Investigative Site

    Beppu, Oita Prefecture, 8740840, Japan

  • Novartis Investigative Site

    Uruma, Okinawa, 9042293, Japan

  • Novartis Investigative Site

    Habikino, Osaka, 5830872, Japan

  • Novartis Investigative Site

    Izumi, Osaka, 5940071, Japan

  • Novartis Investigative Site

    Moriguchi, Osaka, 5708540, Japan

  • Novartis Investigative Site

    Suita, Osaka, 5650871, Japan

  • Novartis Investigative Site

    Saga, Saga-ken, 8498501, Japan

  • Novartis Investigative Site

    Fukaya, Saitama, 3660052, Japan

  • Novartis Investigative Site

    Kawagoe, Saitama, 3508550, Japan

  • Novartis Investigative Site

    Tokorozawa, Saitama, 3590037, Japan

  • Novartis Investigative Site

    Hikone, Shiga, 5220057, Japan

  • Novartis Investigative Site

    Ōtsu, Shiga, 5200804, Japan

  • Novartis Investigative Site

    Rittō, Shiga, 5203046, Japan

  • Novartis Investigative Site

    Iwata, Shizuoka, 4388550, Japan

  • Novartis Investigative Site

    Shimotsuga Gun, Tochigi, 3210293, Japan

  • Novartis Investigative Site

    Shimotsuke, Tochigi, 3290498, Japan

  • Novartis Investigative Site

    Utsunomiya, Tochigi, 3210974, Japan

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo, 1138431, Japan

  • Novartis Investigative Site

    Higashimurayama, Tokyo, 1898511, Japan

  • Novartis Investigative Site

    Itabashi Ku, Tokyo, 1738606, Japan

  • Novartis Investigative Site

    Itabashi-ku, Tokyo, 1738610, Japan

  • Novartis Investigative Site

    Meguro City, Tokyo, 1538581, Japan

  • Novartis Investigative Site

    Minato-ku, Tokyo, 1058471, Japan

  • Novartis Investigative Site

    Nerima City, Tokyo, 1130033, Japan

  • Novartis Investigative Site

    Nerima City, Tokyo, 1790072, Japan

  • Novartis Investigative Site

    Ōta-ku, Tokyo, 1438541, Japan

  • Novartis Investigative Site

    Shibuya-ku, Tokyo, 1508935, Japan

  • Novartis Investigative Site

    Shinagawa Ku, Tokyo, 1418625, Japan

  • Novartis Investigative Site

    Shinagawa-ku, Tokyo, 1428666, Japan

  • Novartis Investigative Site

    Shinjuku Ku, Tokyo, 1600023, Japan

  • Novartis Investigative Site

    Toyama, Toyama, 9300859, Japan

  • Novartis Investigative Site

    Tanabe, Wakayama, 6468588, Japan

  • Novartis Investigative Site

    Kofu, Yamanashi, 4008506, Japan

  • Novartis Investigative Site

    Fukushima, 9601295, Japan

  • Novartis Investigative Site

    Ishikawa, 9208641, Japan

  • Novartis Investigative Site

    Kagoshima, 8920853, Japan

  • Novartis Investigative Site

    Kyoto, 6048845, Japan

  • Novartis Investigative Site

    Kyoto, 6068507, Japan

  • Novartis Investigative Site

    Niigata, 9518520, Japan

  • Novartis Investigative Site

    Okayama, 7008558, Japan

  • Novartis Investigative Site

    Osaka, 5420081, Japan

  • Novartis Investigative Site

    Shizuoka, 4228527, Japan

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