Specified Drug-use Surveillance of Fabhalta Capsules

Last updated: January 30, 2026
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Proteinuria

Hemoglobinuria, Paroxysmal

Red Blood Cell Disorders

Treatment

N/A

Clinical Study ID

NCT06606314
CLNP023C11401
  • Ages < 100
  • All Genders

Study Summary

This is a multicenter, single-arm, non-interventional study (NIS) with a central registration system and an all-case surveillance system. The observation period is 48 weeks after the start of treatment with Fabhalta.

Eligibility Criteria

Inclusion

Inclusion Criteria:

All patients who received Fabhalta.

·

Exclusion

Exclusion Criteria:

Patients receiving Fabhalta for an unapproved indication under the Clinical Trials Act or GCP.

Study Design

Total Participants: 100
Study Start date:
September 18, 2024
Estimated Completion Date:
September 30, 2028

Study Description

The observation period will be 48 weeks after the start of treatment with Fabhalta.

For patients in whom treatment with Fabhalta is discontinued within 48 weeks after the start of the treatment, adverse events occurring by the last day of the treatment + 30 days and concomitant drugs will be monitored and recorded in CRFs.

Connect with a study center

  • Novartis Investigative Site

    Handa, Aichi 475-0817
    Japan

    Site Not Available

  • Novartis Investigative Site

    Nagoya, Aichi 453-8511
    Japan

    Site Not Available

  • Novartis Investigative Site

    Okazaki, Aichi 444-8553
    Japan

    Site Not Available

  • Novartis Investigative Site

    Toyohashi, Aichi 441-8570
    Japan

    Site Not Available

  • Novartis Investigative Site

    Toyota, Aichi 471-8513
    Japan

    Site Not Available

  • Novartis Investigative Site

    Handa 1863209, Aichi-ken 1865694 475-0817
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Nagoya 1856057, Aichi-ken 1865694 466-8650
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Okazaki 1854376, Aichi-ken 1865694 444-8553
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Toyohashi 1849846, Aichi-ken 1865694 441-8570
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Toyota 1849814, Aichi-ken 1865694 471-8513
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Hachinohe, Aomori 039-1104
    Japan

    Site Not Available

  • Novartis Investigative Site

    Hachinohe 2130203, Aomori 2130656 039-1104
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Funabashi 1863905, Chiba 2113014 273-8556
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Kashiwa 1859924, Chiba 2113014 277-8567
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Matsuyama, Ehime 790-8524
    Japan

    Site Not Available

  • Novartis Investigative Site

    Matsuyama 1926099, Ehime 1864226 790-8524
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Kurume-city, Fukuoka 830-8543
    Japan

    Site Not Available

  • Novartis Investigative Site

    Fukuoka 1863967, Fukuoka 1863958 810-8563
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Kurume 1858088, Fukuoka 1863958 830-8543
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Fukushima city, Fukushima 960 1295
    Japan

    Site Not Available

  • Novartis Investigative Site

    Aizu-Wakamatsu 6822148, Fukushima 2112922 9693482
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Kohriyama, Fukushima 2112922 963-8022
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Maebashi-city, Gunma 371-0811
    Japan

    Site Not Available

  • Novartis Investigative Site

    Maebashi 1857843, Gunma 1863501 371-0811
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Fukuyama, Hiroshima 720-0001
    Japan

    Site Not Available

  • Novartis Investigative Site

    Fukuyama 1863917, Hiroshima 1862413 720-0001
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Hakodate, Hokkaido 041-0821
    Japan

    Site Not Available

  • Novartis Investigative Site

    Sapporo, Hokkaido 003-0006
    Japan

    Site Not Available

  • Novartis Investigative Site

    Hakodate 2130188, Hokkaido 2130037 041-0821
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Sapporo 2128295, Hokkaido 2130037 064 0804
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Amagasaki, Hyogo 660-8511
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kobe, Hyogo 650-0047
    Japan

    Site Not Available

  • Novartis Investigative Site

    Amagasaki 1865387, Hyōgo 1862047 660-8511
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Ashiya 1864985, Hyōgo 1862047 659-0012
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Himeji 1862627, Hyōgo 1862047 670-8540
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kobe 1859171, Hyōgo 1862047 651-0072
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Nishinomiya 1855207, Hyōgo 1862047 663 8501
    Japan

    Completed

  • Novartis Investigative Site

    Tsukuba, Ibaraki 300-2622
    Japan

    Site Not Available

  • Novartis Investigative Site

    Tsukuba 2110681, Ibaraki 2112669 Ibaraki
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Kanazawa, Ishikawa 920 8641
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kanazawa 1860243, Ishikawa-ken 1861387 920 8641
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Morioka 2111834, Iwate 2112518 020 0066
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Sakaide-city, Kagawa 762-8550
    Japan

    Site Not Available

  • Novartis Investigative Site

    Sakaidechō 1853190, Kagawa-ken 1860834 762-8550
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Kanoya, Kagoshima 893-0024
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kanoya 1860112, Kagoshima-ken 1860825 893-0024
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Isehara, Kanagawa 259-1193
    Japan

    Site Not Available

  • Novartis Investigative Site

    Yokohama city, Kanagawa 232 0024
    Japan

    Site Not Available

  • Novartis Investigative Site

    Isehara 1861449, Kanagawa 1860291 259-1193
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Yokohama 1848354, Kanagawa 1860291 2320024
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Uji 1849372, Kyoto 1857907 611-0042
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Osaki, Miyagi 989-6183
    Japan

    Site Not Available

  • Novartis Investigative Site

    Ōsaki 6822188, Miyagi 2111888 989-6183
    Japan

    Completed

  • Novartis Investigative Site

    Miyazaki 1856717, Miyazaki 1856710 880-8510
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Nobeoka 1855095, Miyazaki 1856710 882-0835
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Suwa, Nagano 392-8510
    Japan

    Site Not Available

  • Novartis Investigative Site

    Matsumoto 1857519, Nagano 1856210 3908621
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Nagano 1856215, Nagano 1856210 3808582
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Suwa 1851368, Nagano 1856210 392-8510
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Omura, Nagasaki 856-8562
    Japan

    Site Not Available

  • Novartis Investigative Site

    Ōmura 1854093, Nagasaki 1856156 856-8562
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Nagaoka 1856199, Niigata 1855429 940-2085
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Beppu, Oita 874-0840
    Japan

    Site Not Available

  • Novartis Investigative Site

    Beppu 1864750, Oita Prefecture 1854484 874-0840
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Uruma, Okinawa 904-2293
    Japan

    Site Not Available

  • Novartis Investigative Site

    Uruma 6822153, Okinawa 1854345 904-2293
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Habikino City, Osaka 583-0872
    Japan

    Site Not Available

  • Novartis Investigative Site

    Moriguchi, Osaka 570-8540
    Japan

    Site Not Available

  • Novartis Investigative Site

    Habikino 6825496, Osaka 1853904 583-0872
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Izumi 1861107, Osaka 1853904 594-0071
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Moriguchi 1856584, Osaka 1853904 570-8540
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Suita 1851483, Osaka 1853904 565 0871
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Saga-city, Saga 849-8501
    Japan

    Site Not Available

  • Novartis Investigative Site

    Saga 1853303, Saga-ken 1853299 849-8501
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Fukaya, Saitama 366-0052
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kawagoe, Saitama 350 8550
    Japan

    Site Not Available

  • Novartis Investigative Site

    Fukaya 11611661, Saitama 1853226 366-0052
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Kawagoe 1859740, Saitama 1853226 3508550
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Tokorozawa 1850181, Saitama 1853226 359-0037
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Hikone, Shiga 522-0057
    Japan

    Site Not Available

  • Novartis Investigative Site

    Hikone 1862636, Shiga 1852553 522-0057
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Iwata, Shizuoka 438-8550
    Japan

    Site Not Available

  • Novartis Investigative Site

    Iwata 1861171, Shizuoka 1851715 438-8550
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Shimotsuke 6822175, Tochigi 1850310 329-0498
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Bunkyo ku, Tokyo 113-8431
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Nerima, Tokyo 179-0072
    Japan

    Site Not Available

  • Novartis Investigative Site

    Shinagawa ku, Tokyo 141 8625
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo 1850144 1138431
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Higashimurayama 7279570, Tokyo 1850144 189-8511
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Itabashi Ku, Tokyo 1850144 173 8606
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Itabashi-ku, Tokyo 1850144 1738610
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Meguro City 11790374, Tokyo 1850144 153-8581
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Minato-ku, Tokyo 1850144 105-8471
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Nerima City 11790394, Tokyo 1850144 113-0033
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Shinagawa Ku, Tokyo 1850144 141 8625
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Shinagawa-ku, Tokyo 1850144 1428666
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Shinjuku Ku, Tokyo 1850144 160-0023
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Ōta-ku 8469289, Tokyo 1850144 143 8541
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Toyama 1849876, Toyama 1849872 930-0859
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Tanabe 1850708, Wakayama 1848938 646-8588
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Kofu 1859100, Yamanashi 1848649 400-8506
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Fukushima 2112923, 9601295
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Kagoshima 1860827, 892-0853
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Kumamoto 1858421, 860-8556
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Kyoto, 606 8507
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kyoto 1857910, 604-8845
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Miyazaki, 880-8510
    Japan

    Site Not Available

  • Novartis Investigative Site

    Niigata, 951 8520
    Japan

    Site Not Available

  • Novartis Investigative Site

    Niigata 1855431, 9518520
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Osaka, 542-0081
    Japan

    Site Not Available

  • Novartis Investigative Site

    Osaka 1853909, 542-0081
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Shizuoka, 422-8527
    Japan

    Site Not Available

  • Novartis Investigative Site

    Shizuoka 1851717, 422-8527
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Toyama, 930-0859
    Japan

    Site Not Available

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