RecruitingNCT06606314

Specified Drug-use Surveillance of Fabhalta Capsules

Specified Drug-use Surveillance of Fabhalta Capsules (Paroxysmal Nocturnal Hemoglobinuria, CLNP023C11401)


Sponsor

Novartis Pharmaceuticals

Enrollment

100 participants

Start Date

Sep 18, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 0 YearsMax Age: 100 Years

Inclusion Criteria2

  • All patients who received Fabhalta.
  • ·

Exclusion Criteria1

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

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Locations(92)

Novartis Investigative Site

Handa, Aichi-ken, Japan

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Novartis Investigative Site

Okazaki, Aichi-ken, Japan

Novartis Investigative Site

Toyohashi, Aichi-ken, Japan

Novartis Investigative Site

Toyota, Aichi-ken, Japan

Novartis Investigative Site

Toyota, Aichi-ken, Japan

Novartis Investigative Site

Hachinohe, Aomori, Japan

Novartis Investigative Site

Chiba, Chiba, Japan

Novartis Investigative Site

Funabashi, Chiba, Japan

Novartis Investigative Site

Kashiwa, Chiba, Japan

Novartis Investigative Site

Narita, Chiba, Japan

Novartis Investigative Site

Matsuyama, Ehime, Japan

Novartis Investigative Site

Fukuoka, Fukuoka, Japan

Novartis Investigative Site

Kurume, Fukuoka, Japan

Novartis Investigative Site

Aizu-Wakamatsu, Fukushima, Japan

Novartis Investigative Site

Kohriyama, Fukushima, Japan

Novartis Investigative Site

Maebashi, Gunma, Japan

Novartis Investigative Site

Fukuyama, Hiroshima, Japan

Novartis Investigative Site

Hakodate, Hokkaido, Japan

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Novartis Investigative Site

Amagasaki, Hyōgo, Japan

Novartis Investigative Site

Ashiya, Hyōgo, Japan

Novartis Investigative Site

Himeji, Hyōgo, Japan

Novartis Investigative Site

Kobe, Hyōgo, Japan

Novartis Investigative Site

Kobe, Hyōgo, Japan

Novartis Investigative Site

Nishinomiya, Hyōgo, Japan

Novartis Investigative Site

Nishinomiya, Hyōgo, Japan

Novartis Investigative Site

Tsukuba, Ibaraki, Japan

Novartis Investigative Site

Tsukuba, Ibaraki, Japan

Novartis Investigative Site

Tsukuba, Ibaraki, Japan

Novartis Investigative Site

Morioka, Iwate, Japan

Novartis Investigative Site

Sakaidechō, Kagawa-ken, Japan

Novartis Investigative Site

Kanoya, Kagoshima-ken, Japan

Novartis Investigative Site

Isehara, Kanagawa, Japan

Novartis Investigative Site

Isehara, Kanagawa, Japan

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Novartis Investigative Site

Kyoto, Kyoto, Japan

Novartis Investigative Site

Uji, Kyoto, Japan

Novartis Investigative Site

Ōsaki, Miyagi, Japan

Novartis Investigative Site

Miyazaki, Miyazaki, Japan

Novartis Investigative Site

Nobeoka, Miyazaki, Japan

Novartis Investigative Site

Matsumoto, Nagano, Japan

Novartis Investigative Site

Nagano, Nagano, Japan

Novartis Investigative Site

Suwa, Nagano, Japan

Novartis Investigative Site

Ōmura, Nagasaki, Japan

Novartis Investigative Site

Ikoma, Nara, Japan

Novartis Investigative Site

Nagaoka, Niigata, Japan

Novartis Investigative Site

Beppu, Oita Prefecture, Japan

Novartis Investigative Site

Uruma, Okinawa, Japan

Novartis Investigative Site

Habikino, Osaka, Japan

Novartis Investigative Site

Izumi, Osaka, Japan

Novartis Investigative Site

Moriguchi, Osaka, Japan

Novartis Investigative Site

Suita, Osaka, Japan

Novartis Investigative Site

Saga, Saga-ken, Japan

Novartis Investigative Site

Fukaya, Saitama, Japan

Novartis Investigative Site

Kawagoe, Saitama, Japan

Novartis Investigative Site

Tokorozawa, Saitama, Japan

Novartis Investigative Site

Hikone, Shiga, Japan

Novartis Investigative Site

Ōtsu, Shiga, Japan

Novartis Investigative Site

Rittō, Shiga, Japan

Novartis Investigative Site

Iwata, Shizuoka, Japan

Novartis Investigative Site

Shimotsuga Gun, Tochigi, Japan

Novartis Investigative Site

Shimotsuke, Tochigi, Japan

Novartis Investigative Site

Utsunomiya, Tochigi, Japan

Novartis Investigative Site

Bunkyo Ku, Tokyo, Japan

Novartis Investigative Site

Higashimurayama, Tokyo, Japan

Novartis Investigative Site

Itabashi Ku, Tokyo, Japan

Novartis Investigative Site

Itabashi-ku, Tokyo, Japan

Novartis Investigative Site

Meguro City, Tokyo, Japan

Novartis Investigative Site

Minato-ku, Tokyo, Japan

Novartis Investigative Site

Nerima City, Tokyo, Japan

Novartis Investigative Site

Nerima City, Tokyo, Japan

Novartis Investigative Site

Ōta-ku, Tokyo, Japan

Novartis Investigative Site

Shibuya City, Tokyo, Japan

Novartis Investigative Site

Shinagawa Ku, Tokyo, Japan

Novartis Investigative Site

Shinagawa-ku, Tokyo, Japan

Novartis Investigative Site

Shinjuku Ku, Tokyo, Japan

Novartis Investigative Site

Toyama, Toyama, Japan

Novartis Investigative Site

Tanabe, Wakayama, Japan

Novartis Investigative Site

Kofu, Yamanashi, Japan

Novartis Investigative Site

Fukushima, Japan

Novartis Investigative Site

Ishikawa, Japan

Novartis Investigative Site

Kagoshima, Japan

Novartis Investigative Site

Kumamoto, Japan

Novartis Investigative Site

Kyoto, Japan

Novartis Investigative Site

Kyoto, Japan

Novartis Investigative Site

Niigata, Japan

Novartis Investigative Site

Okayama, Japan

Novartis Investigative Site

Osaka, Japan

Novartis Investigative Site

Shizuoka, Japan

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NCT06606314


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