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Specified Drug-use Surveillance of Fabhalta Capsules

Active Not RecruitingN/A

Sponsor: Novartis Pharmaceuticals

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Countries: Japan

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 overview

Sex: ALL

Age: 0 Years to 100 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

All patients who received Fabhalta.

·

Exclusion Criteria:

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

Locations (91)

Handa, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Okazaki, Aichi-ken, Japan
Toyohashi, Aichi-ken, Japan
Toyota, Aichi-ken, Japan
Toyota, Aichi-ken, Japan
Hachinohe, Aomori, Japan
Chiba, Chiba, Japan
Funabashi, Chiba, Japan
Kashiwa, Chiba, Japan
Narita, Chiba, Japan
Matsuyama, Ehime, Japan
Fukuoka, Fukuoka, Japan
Kurume, Fukuoka, Japan
Aizu-Wakamatsu, Fukushima, Japan
Kohriyama, Fukushima, Japan
Maebashi, Gunma, Japan
Fukuyama, Hiroshima, Japan
Hakodate, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Amagasaki, Hyōgo, Japan
Ashiya, Hyōgo, Japan
Himeji, Hyōgo, Japan
Kobe, Hyōgo, Japan
Kobe, Hyōgo, Japan
Nishinomiya, Hyōgo, Japan
Nishinomiya, Hyōgo, Japan
Tsukuba, Ibaraki, Japan
+ 61 more on CT.gov