Specified Drug-use Surveillance of Fabhalta Capsules

Last updated: June 12, 2026
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Red Blood Cell Disorders

White Cell Disorders

Aplastic Anemia

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: 132
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-ken 475-0817
    Japan

    Site Not Available

  • Novartis Investigative Site

    Nagoya, Aichi-ken 453-8511
    Japan

    Site Not Available

  • Novartis Investigative Site

    Okazaki, Aichi-ken 444-8553
    Japan

    Site Not Available

  • Novartis Investigative Site

    Toyohashi, Aichi-ken 441-8570
    Japan

    Site Not Available

  • Novartis Investigative Site

    Toyota, Aichi-ken 470-0343
    Japan

    Site Not Available

  • Novartis Investigative Site

    Nagoya 1856057, Aichi-ken 1865694 453-8511
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Hachinohe, Aomori 0391104
    Japan

    Site Not Available

  • Novartis Investigative Site

    Chiba, Chiba 2608677
    Japan

    Site Not Available

  • Novartis Investigative Site

    Funabashi, Chiba 273-8556
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kashiwa, Chiba 277-8567
    Japan

    Site Not Available

  • Novartis Investigative Site

    Narita, Chiba 286-8523
    Japan

    Site Not Available

  • Novartis Investigative Site

    Matsuyama, Ehime 790-8524
    Japan

    Site Not Available

  • Novartis Investigative Site

    Fukuoka, Fukuoka 810-8563
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kurume, Fukuoka 830-8543
    Japan

    Site Not Available

  • Novartis Investigative Site

    Aizu-Wakamatsu, Fukushima 9693482
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kohriyama, Fukushima 963-8022
    Japan

    Site Not Available

  • Novartis Investigative Site

    Maebashi, Gunma 371-0811
    Japan

    Site Not Available

  • Novartis Investigative Site

    Fukuyama, Hiroshima 720-0001
    Japan

    Site Not Available

  • Novartis Investigative Site

    Hakodate, Hokkaido 0410821
    Japan

    Site Not Available

  • Novartis Investigative Site

    Sapporo, Hokkaido 0030006
    Japan

    Site Not Available

  • Novartis Investigative Site

    Sapporo 2128295, Hokkaido 2130037 003-0006
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Amagasaki, Hyōgo 660-8511
    Japan

    Site Not Available

  • Novartis Investigative Site

    Ashiya, Hyōgo 659-0012
    Japan

    Site Not Available

  • Novartis Investigative Site

    Himeji, Hyōgo 670-8540
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kobe, Hyōgo 6500047
    Japan

    Site Not Available

  • Novartis Investigative Site

    Nishinomiya, Hyōgo 662-0918
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kobe 1859171, Hyōgo 1862047 6500047
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Nishinomiya 1855207, Hyōgo 1862047 663 8501
    Japan

    Completed

  • Novartis Investigative Site

    Tsukuba, Ibaraki 3058576
    Japan

    Site Not Available

  • Novartis Investigative Site

    Tsukuba 2110681, Ibaraki 2112669 300-2622
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Morioka, Iwate 0200066
    Japan

    Site Not Available

  • Novartis Investigative Site

    Sakaidechō, Kagawa-ken 762-8550
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kanoya, Kagoshima-ken 893-0024
    Japan

    Site Not Available

  • Novartis Investigative Site

    Isehara, Kanagawa 259-1193
    Japan

    Site Not Available

  • Novartis Investigative Site

    Yokohama, Kanagawa 232-0024
    Japan

    Site Not Available

  • Novartis Investigative Site

    Yokohama 1848354, Kanagawa 1860291 232 0024
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Kumamoto, Kumamoto 860-8556
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kyoto, Kyoto 603-8151
    Japan

    Site Not Available

  • Novartis Investigative Site

    Uji, Kyoto 611-0042
    Japan

    Site Not Available

  • Novartis Investigative Site

    Ōsaki, Miyagi 989-6183
    Japan

    Site Not Available

  • Novartis Investigative Site

    Miyazaki, Miyazaki 880-8510
    Japan

    Site Not Available

  • Novartis Investigative Site

    Nobeoka, Miyazaki 882-0835
    Japan

    Site Not Available

  • Novartis Investigative Site

    Matsumoto, Nagano 3908621
    Japan

    Site Not Available

  • Novartis Investigative Site

    Nagano, Nagano 3808582
    Japan

    Site Not Available

  • Novartis Investigative Site

    Suwa, Nagano 392-8510
    Japan

    Site Not Available

  • Novartis Investigative Site

    Ōmura, Nagasaki 856-8562
    Japan

    Site Not Available

  • Novartis Investigative Site

    Ikoma, Nara 630-0293
    Japan

    Site Not Available

  • Novartis Investigative Site

    Nagaoka, Niigata 940-2085
    Japan

    Site Not Available

  • Novartis Investigative Site

    Beppu, Oita Prefecture 874-0840
    Japan

    Site Not Available

  • Novartis Investigative Site

    Uruma, Okinawa 904-2293
    Japan

    Site Not Available

  • Novartis Investigative Site

    Habikino, Osaka 583-0872
    Japan

    Site Not Available

  • Novartis Investigative Site

    Izumi, Osaka 594-0071
    Japan

    Site Not Available

  • Novartis Investigative Site

    Moriguchi, Osaka 570-8540
    Japan

    Site Not Available

  • Novartis Investigative Site

    Suita, Osaka 565-0871
    Japan

    Site Not Available

  • Novartis Investigative Site

    Saga, Saga-ken 849-8501
    Japan

    Site Not Available

  • Novartis Investigative Site

    Fukaya, Saitama 366-0052
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kawagoe, Saitama 3508550
    Japan

    Site Not Available

  • Novartis Investigative Site

    Tokorozawa, Saitama 359-0037
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kawagoe 1859740, Saitama 1853226 350 8550
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Hikone, Shiga 522-0057
    Japan

    Site Not Available

  • Novartis Investigative Site

    Rittō, Shiga 520-3046
    Japan

    Site Not Available

  • Novartis Investigative Site

    Ōtsu, Shiga 520-0804
    Japan

    Site Not Available

  • Novartis Investigative Site

    Iwata, Shizuoka 438-8550
    Japan

    Site Not Available

  • Novartis Investigative Site

    Shimotsuga Gun, Tochigi 3210293
    Japan

    Site Not Available

  • Novartis Investigative Site

    Shimotsuke, Tochigi 329-0498
    Japan

    Site Not Available

  • Novartis Investigative Site

    Utsunomiya, Tochigi 321-0974
    Japan

    Site Not Available

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo 1138431
    Japan

    Site Not Available

  • Novartis Investigative Site

    Bunkyo ku, Tokyo 113-8431
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Higashimurayama, Tokyo 189-8511
    Japan

    Site Not Available

  • Novartis Investigative Site

    Itabashi Ku, Tokyo 1738606
    Japan

    Site Not Available

  • Novartis Investigative Site

    Itabashi-ku, Tokyo 1738610
    Japan

    Site Not Available

  • Novartis Investigative Site

    Meguro City, Tokyo 153-8581
    Japan

    Site Not Available

  • Novartis Investigative Site

    Minato-ku, Tokyo 105-8471
    Japan

    Site Not Available

  • Novartis Investigative Site

    Nerima, Tokyo 113-0033
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Nerima City, Tokyo 113-0033
    Japan

    Site Not Available

  • Novartis Investigative Site

    Shibuya City, Tokyo 150-8935
    Japan

    Site Not Available

  • Novartis Investigative Site

    Shinagawa Ku, Tokyo 1418625
    Japan

    Site Not Available

  • Novartis Investigative Site

    Shinagawa-ku, Tokyo 1428666
    Japan

    Site Not Available

  • Novartis Investigative Site

    Shinjuku Ku, Tokyo 160-0023
    Japan

    Site Not Available

  • Novartis Investigative Site

    Ōta-ku, Tokyo 1438541
    Japan

    Site Not Available

  • Novartis Investigative Site

    Nerima City 11790394, Tokyo 1850144 179-0072
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Toyama, Toyama 930-0859
    Japan

    Site Not Available

  • Novartis Investigative Site

    Tanabe, Wakayama 646-8588
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kofu, Yamanashi 400-8506
    Japan

    Site Not Available

  • Novartis Investigative Site

    Fukushima, 9601295
    Japan

    Site Not Available

  • Novartis Investigative Site

    Fukushima 2112923, 960 1295
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Ishikawa, 9208641
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kagoshima, 892-0853
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kyoto 1857910, 604-8845
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Niigata, 9518520
    Japan

    Site Not Available

  • Novartis Investigative Site

    Niigata 1855431, 951 8520
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Okayama, 7008558
    Japan

    Site Not Available

  • Novartis Investigative Site

    Osaka, 542-0081
    Japan

    Site Not Available

  • Novartis Investigative Site

    Shizuoka, 422-8527
    Japan

    Site Not Available

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